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Luis Bahamondes - One of the best experts on this subject based on the ideXlab platform.

  • control of endometriosis associated pain with etonogestrel releasing contraceptive implant and 52 mg levonorgestrel releasing intrauterine system randomized clinical trial
    Fertility and Sterility, 2018
    Co-Authors: Nelsilene Mota Carvalho, Deborah Margatho, Kleber Cursino, Cristina Laguna Benettipinto, Luis Bahamondes
    Abstract:

    Objective To assess the efficacy of an etonogestrel (ENG)-releasing contraceptive implant or the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) in the control of endometriosis-associated pelvic pain. Design Noninferiority randomized clinical trial in which women with endometriosis were assigned to use an ENG implant (experimental treatment) or an LNG-IUS (active comparator). Monthly follow-up visits were conducted up to 6 months. Setting University teaching hospital. Patient(s) One hundred three women, with endometriosis-associated chronic pelvic pain, dysmenorrhea, or both for more than 6 months. In cases of deep endometriosis, vaginal ultrasonography and magnetic resonance imaging were used as additional diagnostic tools. Intervention(s) The ENG implant or the LNG-IUS were inserted within the first 5 days of the menstrual cycle. Main Outcome Measure(s) Daily scores of noncyclic pelvic pain and dysmenorrhea were evaluated using a daily visual analogue scale. Health-related quality of life was evaluated using the Endometriosis Health Profile-30 questionnaire at baseline and up to 6 months. Bleeding patterns were assessed daily from a menstrual calendar. Result(s) Both contraceptives improved significantly the mean visual analogue scale endometriosis-associated pelvic pain and dysmenorrhea, without significant differences between treatment group profiles. Health-related quality of life improved significantly in all domains of the core and modular segments of the Endometriosis Health Profile-30 questionnaire, with no difference between both treatment groups. The most common bleeding patterns at 180 days of follow-up were amenorrhea and infrequent bleeding and infrequent bleeding and spotting among ENG implant and LNG-IUS users, respectively. Conclusion(s) In this noninferiority study both contraceptives improved significantly pelvic pain, dysmenorrhea, and health-related quality of life in endometriosis. Clinical Trial Registration Number Clinicaltrials.gov under number NCT02480647 .

  • a multicenter randomized clinical trial of etonogestrel and levonorgestrel contraceptive implants with nonrandomized copper intrauterine device controls effect on weight variations up to 3 years after placement
    Contraception, 2018
    Co-Authors: Luis Bahamondes, Moazzam Ali, Vivian Brache, Ndema Habib
    Abstract:

    Abstract Objectives To evaluate weight changes in women randomized to either the etonogestrel (ENG)- or the levonorgestrel (LNG)-releasing contraceptive implants and to compare with users of the TCu380A intrauterine device (IUD). Study design A multicenter randomized trial with 1:1 allocation ratio of the ENG and the LNG implants with nonrandomized, age-matched control group of women choosing TCu380A IUD. The primary objective was to assess contraceptive efficacy and method continuation rates and, secondarily, the incidence of common complaints and side effects (including weight changes) associated with use of the three contraceptives. All women were enrolled in nine centers at seven countries. Weight change was evaluated from time at device(s) placement. Confounders were sociodemographic, baseline weight and body mass index, center and time from insertion. We used a linear mixed-effects regression modeling with random intercept and slope. Weight was compared between the two implants groups and between the implants and the IUD groups through linear mixed multivariable regression model. Results A total of 995, 997 and 971 users in the ENG implant, LNG implant and IUD groups, respectively, were included. At 36 months of use, ENG and LNG implant users had similar significant mean weight increase of 3.0 kg [95% confidence interval (CI) 2.5–3.5] and 2.9 kg (95% CI 2.4–3.4), respectively (p Conclusions ENG and LNG implant as well as IUD users had a small but significant weight increase with little clinical significance during the 3 years of follow-up, and it was slightly higher among implant than IUD users weighing >50 kg. Implications These findings must be useful for clinicians to counsel implant users which could improve method continuation.

  • extended use up to 5 years of the etonogestrel releasing subdermal contraceptive implant comparison to levonorgestrel releasing subdermal implant
    Human Reproduction, 2016
    Co-Authors: Moazzam Ali, Luis Bahamondes, Sihem Landoulsi, Ayse Akin, Vivian Brache, Ndema Habib, David Hubacher
    Abstract:

    Study question Is it possible to extend the use of the 3-year one-rod etonogestrel (ENG)-releasing subdermal contraceptive implant to 5 years? Summary answer The extended use of the one-rod ENG-releasing subdermal contraceptive implant showed 100% efficacy in years 4 and 5. What is known already The initial regulated trials on the ENG-releasing subdermal contraceptive implant conducted in the 1990 s were designed to measure cumulative 3-year efficacy. The ENG-implant has both well established safety and efficacy for up to 3 years. Pharmacokinetic data on ENG show high levels at 3 years and some previous clinical research confirms efficacy beyond the current approved duration of 3 years. Today, many women, because the labeled duration has been reached, have the ENG implant removed at 3 years, increasing costs, inconvenience and risks. Study design size, duration For the first 3 years, this study was an open-label, multi-centre randomized trial comparing the 3-year ENG implant to the 5-year levonorgestrel (LNG)-releasing implant. After 3 years, a subset of 390 ENG participants, consented to extended use. We compared efficacy, side effects and removal procedures of both implants. We used Kaplan-Meier (K-M) analysis. We included an observational cohort of copper intrauterine device (IUD) users as non-users of hormonal contraceptive method for comparative purposes. Participants/materials, setting, methods The study took place in family planning clinics in seven countries worldwide. Women were enlisted after an eligibility check and informed consent, and 1328 women were enrolled: 390, 522 and 416 in the ENG-implant, LNG-implant and IUD groups, respectively. Main results and the role of chance Over 200 women used the ENG implant for at least 5 years. No pregnancies occurred during the additional 2 years of follow up in the ENG or LNG implant group. The overall 5-year K-M cumulative pregnancy rates for ENG- and LNG- implants were 0.6 per 100 women-years (W-Y) [95% confidence interval (CI): 0.2-1.8] and 0.8 per 100 W-Y [95% CI: 0.2-2.3], respectively. Complaints of bleeding changes were similar; however, ENG-users were more likely than LNG-users to experience heavy bleeding (p Limitations, reasons for caution Few women were ≤19 years old or nulligravida. Although there was no weight limit for enrolment in the study, the number of women ≥70 kg were few. Wider implications of the findings The results from this study corroborate previous evidence showing high contraceptive efficacy through 4 years for the ENG-implant. Data through 5 years are a novel contribution and further proof of the product's capability to provide safe and effective contraception that rivals the current 5-year LNG-subdermal implant. The findings provide valuable information for policy makers, family planning programmers and clinicians that the ENG-releasing subdermal implant is still highly effective up to 5 years after insertion. Compared to previous efforts, our study population was geographically diverse and our study had the highest number of participants completing at least 5 years of use. Trial registration The trial was registered as ISRCTN33378571. Study funding/competing interests The contraceptive devices and funds for conduct of the study were provided by the United Nations Development Programme/United Nations Population Fund/World Health Organization (WHO)/UNICEF/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), WHO. This report contains the collective views of an international group of experts, and does not necessarily represent the decisions or the stated policy of the WHO. All stated authors have no conflict of interest, except Dr Hubacher who reported grants from United States Agency for International Development, during the conduct of the study; other from Advisory Boards (Teva, Bayer, OCON), outside the submitted work.

  • a 3 year multicentre randomized controlled trial of etonogestrel and levonorgestrel releasing contraceptive implants with non randomized matched copper intrauterine device controls
    Human Reproduction, 2015
    Co-Authors: Luis Bahamondes, Moazzam Ali, Vivian Brache, Ndema Habib, O Meirik, Sihem Landoulsi
    Abstract:

    STUDY QUESTION: Is there any difference in the clinical performance of the 3-year one-rod etonogestrel (ENG)- and the 5-year two-rod levonorgestrel (LNG)-releasing contraceptive implants during 3 years of insertion and between implant and intrauterine device (IUD) contraception in particular complaints possibly related to hormonal contraceptives? SUMMARY ANSWER: The cumulative contraceptive effectiveness after 3 years and method continuation through 2.5 years were not significantly different between ENG and LNG implants but both outcomes were significantly worse in the non-randomized age-matched group of IUD users than in the combined implant group. WHAT IS KNOWN ALREADY: ENG- and LNG-releasing implants are safe and highly efficacious contraceptives with pregnancy rates reported to be 0.0-0.5 per 100 women-years (W-Y). No head-to-head comparative study of the two implants has been undertaken and little information is available on comparisons of complaints of side effects of implant and copper IUD users. STUDY DESIGN SIZE DURATION: This was an open parallel group RCT with 1:1 allocation ratio of the ENG and the LNG implants with non-randomized control group of women choosing TCu380A IUD to address lack of reliable data on common side effects typically attributed to the use of progestogen-only contraceptives. After device(s) placement follow-ups were at 2 weeks 3 and 6 months and semi-annually thereafter for 3 years or until pregnancy removal or expulsion of the implant/IUD occurred. PARTICIPANTS SETTING METHODS: The study took place in family planning clinics in Brazil Chile Dominican Republic Hungary Thailand Turkey and Zimbabwe. Women seeking long-term contraception were enlisted after an eligibility check and informed consent and 2982 women were enrolled: 1003 1005 and 974 in the ENG-implant LNG-implant and IUD groups respectively; 995 997 and 971 respectively were included in the per protocol analysis reported here. MAIN RESULTS AND THE ROLE OF CHANCE: ENG and LNG implants each had the same 3-year cumulative pregnancy rate of 0.4 per 100 W-Y [95% confidence interval (CI) 0.1-1.4]. A weight of >/=70 kg at admission was unrelated to pregnancy. Method continuation rates for ENG and LNG implants at 2.5 years were 69.8 (95% CI 66.8-72.6) and 71.8 per 100 W-Y (68.8-74.5) and at 3 years 12.1 (95% CI 5.2-22.0) and 52.0 per 100 W-Y (95% CI 41.8-61.2) respectively. Bleeding disturbances the most frequent reason for method discontinuation were significantly more common in the ENG group [16.7 (95% CI 14.4-19.3)] than in the LNG group [12.5 (95% CI 10.5-14.9)] (P 0.019). The 3-year cumulative loss to follow-up was lower in the ENG- than in the LNG-implant group 8.1 (95% CI 6.4-10.2) and 14.4 per 100 W-Y (95% CI 12.1-17.1) respectively. The median duration of implant removal was 50 s shorter among women with ENG than among women with LNG implant (P /=70 kg was <20% and <8% were obese. WIDER IMPLICATIONS OF THE FINDINGS: Findings of the study can inform policy makers and clinicians about choice of implant but also about TCu380A IUD in relation to implants. STUDY FUNDING/COMPETING INTERESTS: UNDP/UNFPA/WHO/UNICEF/World Bank Special Programme of Research Development and Research Training in Human Reproduction (HRP) Department of Reproductive Health and Research (RHR) World Health Organization (WHO). This report contains the views of an international expert group and does not necessarily represent the decisions or the stated policy of the WHO. TRIAL REGISTRATION: ISRCTN33378571 registered on 22 March 2004. The first participant was enrolled on 12 May 2003. (c) The Author 2015. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions please email: journals.permissions@oup.com.

Ndema Habib - One of the best experts on this subject based on the ideXlab platform.

  • a multicenter randomized clinical trial of etonogestrel and levonorgestrel contraceptive implants with nonrandomized copper intrauterine device controls effect on weight variations up to 3 years after placement
    Contraception, 2018
    Co-Authors: Luis Bahamondes, Moazzam Ali, Vivian Brache, Ndema Habib
    Abstract:

    Abstract Objectives To evaluate weight changes in women randomized to either the etonogestrel (ENG)- or the levonorgestrel (LNG)-releasing contraceptive implants and to compare with users of the TCu380A intrauterine device (IUD). Study design A multicenter randomized trial with 1:1 allocation ratio of the ENG and the LNG implants with nonrandomized, age-matched control group of women choosing TCu380A IUD. The primary objective was to assess contraceptive efficacy and method continuation rates and, secondarily, the incidence of common complaints and side effects (including weight changes) associated with use of the three contraceptives. All women were enrolled in nine centers at seven countries. Weight change was evaluated from time at device(s) placement. Confounders were sociodemographic, baseline weight and body mass index, center and time from insertion. We used a linear mixed-effects regression modeling with random intercept and slope. Weight was compared between the two implants groups and between the implants and the IUD groups through linear mixed multivariable regression model. Results A total of 995, 997 and 971 users in the ENG implant, LNG implant and IUD groups, respectively, were included. At 36 months of use, ENG and LNG implant users had similar significant mean weight increase of 3.0 kg [95% confidence interval (CI) 2.5–3.5] and 2.9 kg (95% CI 2.4–3.4), respectively (p Conclusions ENG and LNG implant as well as IUD users had a small but significant weight increase with little clinical significance during the 3 years of follow-up, and it was slightly higher among implant than IUD users weighing >50 kg. Implications These findings must be useful for clinicians to counsel implant users which could improve method continuation.

  • extended use up to 5 years of the etonogestrel releasing subdermal contraceptive implant comparison to levonorgestrel releasing subdermal implant
    Human Reproduction, 2016
    Co-Authors: Moazzam Ali, Luis Bahamondes, Sihem Landoulsi, Ayse Akin, Vivian Brache, Ndema Habib, David Hubacher
    Abstract:

    Study question Is it possible to extend the use of the 3-year one-rod etonogestrel (ENG)-releasing subdermal contraceptive implant to 5 years? Summary answer The extended use of the one-rod ENG-releasing subdermal contraceptive implant showed 100% efficacy in years 4 and 5. What is known already The initial regulated trials on the ENG-releasing subdermal contraceptive implant conducted in the 1990 s were designed to measure cumulative 3-year efficacy. The ENG-implant has both well established safety and efficacy for up to 3 years. Pharmacokinetic data on ENG show high levels at 3 years and some previous clinical research confirms efficacy beyond the current approved duration of 3 years. Today, many women, because the labeled duration has been reached, have the ENG implant removed at 3 years, increasing costs, inconvenience and risks. Study design size, duration For the first 3 years, this study was an open-label, multi-centre randomized trial comparing the 3-year ENG implant to the 5-year levonorgestrel (LNG)-releasing implant. After 3 years, a subset of 390 ENG participants, consented to extended use. We compared efficacy, side effects and removal procedures of both implants. We used Kaplan-Meier (K-M) analysis. We included an observational cohort of copper intrauterine device (IUD) users as non-users of hormonal contraceptive method for comparative purposes. Participants/materials, setting, methods The study took place in family planning clinics in seven countries worldwide. Women were enlisted after an eligibility check and informed consent, and 1328 women were enrolled: 390, 522 and 416 in the ENG-implant, LNG-implant and IUD groups, respectively. Main results and the role of chance Over 200 women used the ENG implant for at least 5 years. No pregnancies occurred during the additional 2 years of follow up in the ENG or LNG implant group. The overall 5-year K-M cumulative pregnancy rates for ENG- and LNG- implants were 0.6 per 100 women-years (W-Y) [95% confidence interval (CI): 0.2-1.8] and 0.8 per 100 W-Y [95% CI: 0.2-2.3], respectively. Complaints of bleeding changes were similar; however, ENG-users were more likely than LNG-users to experience heavy bleeding (p Limitations, reasons for caution Few women were ≤19 years old or nulligravida. Although there was no weight limit for enrolment in the study, the number of women ≥70 kg were few. Wider implications of the findings The results from this study corroborate previous evidence showing high contraceptive efficacy through 4 years for the ENG-implant. Data through 5 years are a novel contribution and further proof of the product's capability to provide safe and effective contraception that rivals the current 5-year LNG-subdermal implant. The findings provide valuable information for policy makers, family planning programmers and clinicians that the ENG-releasing subdermal implant is still highly effective up to 5 years after insertion. Compared to previous efforts, our study population was geographically diverse and our study had the highest number of participants completing at least 5 years of use. Trial registration The trial was registered as ISRCTN33378571. Study funding/competing interests The contraceptive devices and funds for conduct of the study were provided by the United Nations Development Programme/United Nations Population Fund/World Health Organization (WHO)/UNICEF/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), WHO. This report contains the collective views of an international group of experts, and does not necessarily represent the decisions or the stated policy of the WHO. All stated authors have no conflict of interest, except Dr Hubacher who reported grants from United States Agency for International Development, during the conduct of the study; other from Advisory Boards (Teva, Bayer, OCON), outside the submitted work.

  • a 3 year multicentre randomized controlled trial of etonogestrel and levonorgestrel releasing contraceptive implants with non randomized matched copper intrauterine device controls
    Human Reproduction, 2015
    Co-Authors: Luis Bahamondes, Moazzam Ali, Vivian Brache, Ndema Habib, O Meirik, Sihem Landoulsi
    Abstract:

    STUDY QUESTION: Is there any difference in the clinical performance of the 3-year one-rod etonogestrel (ENG)- and the 5-year two-rod levonorgestrel (LNG)-releasing contraceptive implants during 3 years of insertion and between implant and intrauterine device (IUD) contraception in particular complaints possibly related to hormonal contraceptives? SUMMARY ANSWER: The cumulative contraceptive effectiveness after 3 years and method continuation through 2.5 years were not significantly different between ENG and LNG implants but both outcomes were significantly worse in the non-randomized age-matched group of IUD users than in the combined implant group. WHAT IS KNOWN ALREADY: ENG- and LNG-releasing implants are safe and highly efficacious contraceptives with pregnancy rates reported to be 0.0-0.5 per 100 women-years (W-Y). No head-to-head comparative study of the two implants has been undertaken and little information is available on comparisons of complaints of side effects of implant and copper IUD users. STUDY DESIGN SIZE DURATION: This was an open parallel group RCT with 1:1 allocation ratio of the ENG and the LNG implants with non-randomized control group of women choosing TCu380A IUD to address lack of reliable data on common side effects typically attributed to the use of progestogen-only contraceptives. After device(s) placement follow-ups were at 2 weeks 3 and 6 months and semi-annually thereafter for 3 years or until pregnancy removal or expulsion of the implant/IUD occurred. PARTICIPANTS SETTING METHODS: The study took place in family planning clinics in Brazil Chile Dominican Republic Hungary Thailand Turkey and Zimbabwe. Women seeking long-term contraception were enlisted after an eligibility check and informed consent and 2982 women were enrolled: 1003 1005 and 974 in the ENG-implant LNG-implant and IUD groups respectively; 995 997 and 971 respectively were included in the per protocol analysis reported here. MAIN RESULTS AND THE ROLE OF CHANCE: ENG and LNG implants each had the same 3-year cumulative pregnancy rate of 0.4 per 100 W-Y [95% confidence interval (CI) 0.1-1.4]. A weight of >/=70 kg at admission was unrelated to pregnancy. Method continuation rates for ENG and LNG implants at 2.5 years were 69.8 (95% CI 66.8-72.6) and 71.8 per 100 W-Y (68.8-74.5) and at 3 years 12.1 (95% CI 5.2-22.0) and 52.0 per 100 W-Y (95% CI 41.8-61.2) respectively. Bleeding disturbances the most frequent reason for method discontinuation were significantly more common in the ENG group [16.7 (95% CI 14.4-19.3)] than in the LNG group [12.5 (95% CI 10.5-14.9)] (P 0.019). The 3-year cumulative loss to follow-up was lower in the ENG- than in the LNG-implant group 8.1 (95% CI 6.4-10.2) and 14.4 per 100 W-Y (95% CI 12.1-17.1) respectively. The median duration of implant removal was 50 s shorter among women with ENG than among women with LNG implant (P /=70 kg was <20% and <8% were obese. WIDER IMPLICATIONS OF THE FINDINGS: Findings of the study can inform policy makers and clinicians about choice of implant but also about TCu380A IUD in relation to implants. STUDY FUNDING/COMPETING INTERESTS: UNDP/UNFPA/WHO/UNICEF/World Bank Special Programme of Research Development and Research Training in Human Reproduction (HRP) Department of Reproductive Health and Research (RHR) World Health Organization (WHO). This report contains the views of an international expert group and does not necessarily represent the decisions or the stated policy of the WHO. TRIAL REGISTRATION: ISRCTN33378571 registered on 22 March 2004. The first participant was enrolled on 12 May 2003. (c) The Author 2015. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions please email: journals.permissions@oup.com.

Moazzam Ali - One of the best experts on this subject based on the ideXlab platform.

  • a multicenter randomized clinical trial of etonogestrel and levonorgestrel contraceptive implants with nonrandomized copper intrauterine device controls effect on weight variations up to 3 years after placement
    Contraception, 2018
    Co-Authors: Luis Bahamondes, Moazzam Ali, Vivian Brache, Ndema Habib
    Abstract:

    Abstract Objectives To evaluate weight changes in women randomized to either the etonogestrel (ENG)- or the levonorgestrel (LNG)-releasing contraceptive implants and to compare with users of the TCu380A intrauterine device (IUD). Study design A multicenter randomized trial with 1:1 allocation ratio of the ENG and the LNG implants with nonrandomized, age-matched control group of women choosing TCu380A IUD. The primary objective was to assess contraceptive efficacy and method continuation rates and, secondarily, the incidence of common complaints and side effects (including weight changes) associated with use of the three contraceptives. All women were enrolled in nine centers at seven countries. Weight change was evaluated from time at device(s) placement. Confounders were sociodemographic, baseline weight and body mass index, center and time from insertion. We used a linear mixed-effects regression modeling with random intercept and slope. Weight was compared between the two implants groups and between the implants and the IUD groups through linear mixed multivariable regression model. Results A total of 995, 997 and 971 users in the ENG implant, LNG implant and IUD groups, respectively, were included. At 36 months of use, ENG and LNG implant users had similar significant mean weight increase of 3.0 kg [95% confidence interval (CI) 2.5–3.5] and 2.9 kg (95% CI 2.4–3.4), respectively (p Conclusions ENG and LNG implant as well as IUD users had a small but significant weight increase with little clinical significance during the 3 years of follow-up, and it was slightly higher among implant than IUD users weighing >50 kg. Implications These findings must be useful for clinicians to counsel implant users which could improve method continuation.

  • extended use up to 5 years of the etonogestrel releasing subdermal contraceptive implant comparison to levonorgestrel releasing subdermal implant
    Human Reproduction, 2016
    Co-Authors: Moazzam Ali, Luis Bahamondes, Sihem Landoulsi, Ayse Akin, Vivian Brache, Ndema Habib, David Hubacher
    Abstract:

    Study question Is it possible to extend the use of the 3-year one-rod etonogestrel (ENG)-releasing subdermal contraceptive implant to 5 years? Summary answer The extended use of the one-rod ENG-releasing subdermal contraceptive implant showed 100% efficacy in years 4 and 5. What is known already The initial regulated trials on the ENG-releasing subdermal contraceptive implant conducted in the 1990 s were designed to measure cumulative 3-year efficacy. The ENG-implant has both well established safety and efficacy for up to 3 years. Pharmacokinetic data on ENG show high levels at 3 years and some previous clinical research confirms efficacy beyond the current approved duration of 3 years. Today, many women, because the labeled duration has been reached, have the ENG implant removed at 3 years, increasing costs, inconvenience and risks. Study design size, duration For the first 3 years, this study was an open-label, multi-centre randomized trial comparing the 3-year ENG implant to the 5-year levonorgestrel (LNG)-releasing implant. After 3 years, a subset of 390 ENG participants, consented to extended use. We compared efficacy, side effects and removal procedures of both implants. We used Kaplan-Meier (K-M) analysis. We included an observational cohort of copper intrauterine device (IUD) users as non-users of hormonal contraceptive method for comparative purposes. Participants/materials, setting, methods The study took place in family planning clinics in seven countries worldwide. Women were enlisted after an eligibility check and informed consent, and 1328 women were enrolled: 390, 522 and 416 in the ENG-implant, LNG-implant and IUD groups, respectively. Main results and the role of chance Over 200 women used the ENG implant for at least 5 years. No pregnancies occurred during the additional 2 years of follow up in the ENG or LNG implant group. The overall 5-year K-M cumulative pregnancy rates for ENG- and LNG- implants were 0.6 per 100 women-years (W-Y) [95% confidence interval (CI): 0.2-1.8] and 0.8 per 100 W-Y [95% CI: 0.2-2.3], respectively. Complaints of bleeding changes were similar; however, ENG-users were more likely than LNG-users to experience heavy bleeding (p Limitations, reasons for caution Few women were ≤19 years old or nulligravida. Although there was no weight limit for enrolment in the study, the number of women ≥70 kg were few. Wider implications of the findings The results from this study corroborate previous evidence showing high contraceptive efficacy through 4 years for the ENG-implant. Data through 5 years are a novel contribution and further proof of the product's capability to provide safe and effective contraception that rivals the current 5-year LNG-subdermal implant. The findings provide valuable information for policy makers, family planning programmers and clinicians that the ENG-releasing subdermal implant is still highly effective up to 5 years after insertion. Compared to previous efforts, our study population was geographically diverse and our study had the highest number of participants completing at least 5 years of use. Trial registration The trial was registered as ISRCTN33378571. Study funding/competing interests The contraceptive devices and funds for conduct of the study were provided by the United Nations Development Programme/United Nations Population Fund/World Health Organization (WHO)/UNICEF/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), WHO. This report contains the collective views of an international group of experts, and does not necessarily represent the decisions or the stated policy of the WHO. All stated authors have no conflict of interest, except Dr Hubacher who reported grants from United States Agency for International Development, during the conduct of the study; other from Advisory Boards (Teva, Bayer, OCON), outside the submitted work.

  • a 3 year multicentre randomized controlled trial of etonogestrel and levonorgestrel releasing contraceptive implants with non randomized matched copper intrauterine device controls
    Human Reproduction, 2015
    Co-Authors: Luis Bahamondes, Moazzam Ali, Vivian Brache, Ndema Habib, O Meirik, Sihem Landoulsi
    Abstract:

    STUDY QUESTION: Is there any difference in the clinical performance of the 3-year one-rod etonogestrel (ENG)- and the 5-year two-rod levonorgestrel (LNG)-releasing contraceptive implants during 3 years of insertion and between implant and intrauterine device (IUD) contraception in particular complaints possibly related to hormonal contraceptives? SUMMARY ANSWER: The cumulative contraceptive effectiveness after 3 years and method continuation through 2.5 years were not significantly different between ENG and LNG implants but both outcomes were significantly worse in the non-randomized age-matched group of IUD users than in the combined implant group. WHAT IS KNOWN ALREADY: ENG- and LNG-releasing implants are safe and highly efficacious contraceptives with pregnancy rates reported to be 0.0-0.5 per 100 women-years (W-Y). No head-to-head comparative study of the two implants has been undertaken and little information is available on comparisons of complaints of side effects of implant and copper IUD users. STUDY DESIGN SIZE DURATION: This was an open parallel group RCT with 1:1 allocation ratio of the ENG and the LNG implants with non-randomized control group of women choosing TCu380A IUD to address lack of reliable data on common side effects typically attributed to the use of progestogen-only contraceptives. After device(s) placement follow-ups were at 2 weeks 3 and 6 months and semi-annually thereafter for 3 years or until pregnancy removal or expulsion of the implant/IUD occurred. PARTICIPANTS SETTING METHODS: The study took place in family planning clinics in Brazil Chile Dominican Republic Hungary Thailand Turkey and Zimbabwe. Women seeking long-term contraception were enlisted after an eligibility check and informed consent and 2982 women were enrolled: 1003 1005 and 974 in the ENG-implant LNG-implant and IUD groups respectively; 995 997 and 971 respectively were included in the per protocol analysis reported here. MAIN RESULTS AND THE ROLE OF CHANCE: ENG and LNG implants each had the same 3-year cumulative pregnancy rate of 0.4 per 100 W-Y [95% confidence interval (CI) 0.1-1.4]. A weight of >/=70 kg at admission was unrelated to pregnancy. Method continuation rates for ENG and LNG implants at 2.5 years were 69.8 (95% CI 66.8-72.6) and 71.8 per 100 W-Y (68.8-74.5) and at 3 years 12.1 (95% CI 5.2-22.0) and 52.0 per 100 W-Y (95% CI 41.8-61.2) respectively. Bleeding disturbances the most frequent reason for method discontinuation were significantly more common in the ENG group [16.7 (95% CI 14.4-19.3)] than in the LNG group [12.5 (95% CI 10.5-14.9)] (P 0.019). The 3-year cumulative loss to follow-up was lower in the ENG- than in the LNG-implant group 8.1 (95% CI 6.4-10.2) and 14.4 per 100 W-Y (95% CI 12.1-17.1) respectively. The median duration of implant removal was 50 s shorter among women with ENG than among women with LNG implant (P /=70 kg was <20% and <8% were obese. WIDER IMPLICATIONS OF THE FINDINGS: Findings of the study can inform policy makers and clinicians about choice of implant but also about TCu380A IUD in relation to implants. STUDY FUNDING/COMPETING INTERESTS: UNDP/UNFPA/WHO/UNICEF/World Bank Special Programme of Research Development and Research Training in Human Reproduction (HRP) Department of Reproductive Health and Research (RHR) World Health Organization (WHO). This report contains the views of an international expert group and does not necessarily represent the decisions or the stated policy of the WHO. TRIAL REGISTRATION: ISRCTN33378571 registered on 22 March 2004. The first participant was enrolled on 12 May 2003. (c) The Author 2015. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions please email: journals.permissions@oup.com.

Vivian Brache - One of the best experts on this subject based on the ideXlab platform.

  • a multicenter randomized clinical trial of etonogestrel and levonorgestrel contraceptive implants with nonrandomized copper intrauterine device controls effect on weight variations up to 3 years after placement
    Contraception, 2018
    Co-Authors: Luis Bahamondes, Moazzam Ali, Vivian Brache, Ndema Habib
    Abstract:

    Abstract Objectives To evaluate weight changes in women randomized to either the etonogestrel (ENG)- or the levonorgestrel (LNG)-releasing contraceptive implants and to compare with users of the TCu380A intrauterine device (IUD). Study design A multicenter randomized trial with 1:1 allocation ratio of the ENG and the LNG implants with nonrandomized, age-matched control group of women choosing TCu380A IUD. The primary objective was to assess contraceptive efficacy and method continuation rates and, secondarily, the incidence of common complaints and side effects (including weight changes) associated with use of the three contraceptives. All women were enrolled in nine centers at seven countries. Weight change was evaluated from time at device(s) placement. Confounders were sociodemographic, baseline weight and body mass index, center and time from insertion. We used a linear mixed-effects regression modeling with random intercept and slope. Weight was compared between the two implants groups and between the implants and the IUD groups through linear mixed multivariable regression model. Results A total of 995, 997 and 971 users in the ENG implant, LNG implant and IUD groups, respectively, were included. At 36 months of use, ENG and LNG implant users had similar significant mean weight increase of 3.0 kg [95% confidence interval (CI) 2.5–3.5] and 2.9 kg (95% CI 2.4–3.4), respectively (p Conclusions ENG and LNG implant as well as IUD users had a small but significant weight increase with little clinical significance during the 3 years of follow-up, and it was slightly higher among implant than IUD users weighing >50 kg. Implications These findings must be useful for clinicians to counsel implant users which could improve method continuation.

  • extended use up to 5 years of the etonogestrel releasing subdermal contraceptive implant comparison to levonorgestrel releasing subdermal implant
    Human Reproduction, 2016
    Co-Authors: Moazzam Ali, Luis Bahamondes, Sihem Landoulsi, Ayse Akin, Vivian Brache, Ndema Habib, David Hubacher
    Abstract:

    Study question Is it possible to extend the use of the 3-year one-rod etonogestrel (ENG)-releasing subdermal contraceptive implant to 5 years? Summary answer The extended use of the one-rod ENG-releasing subdermal contraceptive implant showed 100% efficacy in years 4 and 5. What is known already The initial regulated trials on the ENG-releasing subdermal contraceptive implant conducted in the 1990 s were designed to measure cumulative 3-year efficacy. The ENG-implant has both well established safety and efficacy for up to 3 years. Pharmacokinetic data on ENG show high levels at 3 years and some previous clinical research confirms efficacy beyond the current approved duration of 3 years. Today, many women, because the labeled duration has been reached, have the ENG implant removed at 3 years, increasing costs, inconvenience and risks. Study design size, duration For the first 3 years, this study was an open-label, multi-centre randomized trial comparing the 3-year ENG implant to the 5-year levonorgestrel (LNG)-releasing implant. After 3 years, a subset of 390 ENG participants, consented to extended use. We compared efficacy, side effects and removal procedures of both implants. We used Kaplan-Meier (K-M) analysis. We included an observational cohort of copper intrauterine device (IUD) users as non-users of hormonal contraceptive method for comparative purposes. Participants/materials, setting, methods The study took place in family planning clinics in seven countries worldwide. Women were enlisted after an eligibility check and informed consent, and 1328 women were enrolled: 390, 522 and 416 in the ENG-implant, LNG-implant and IUD groups, respectively. Main results and the role of chance Over 200 women used the ENG implant for at least 5 years. No pregnancies occurred during the additional 2 years of follow up in the ENG or LNG implant group. The overall 5-year K-M cumulative pregnancy rates for ENG- and LNG- implants were 0.6 per 100 women-years (W-Y) [95% confidence interval (CI): 0.2-1.8] and 0.8 per 100 W-Y [95% CI: 0.2-2.3], respectively. Complaints of bleeding changes were similar; however, ENG-users were more likely than LNG-users to experience heavy bleeding (p Limitations, reasons for caution Few women were ≤19 years old or nulligravida. Although there was no weight limit for enrolment in the study, the number of women ≥70 kg were few. Wider implications of the findings The results from this study corroborate previous evidence showing high contraceptive efficacy through 4 years for the ENG-implant. Data through 5 years are a novel contribution and further proof of the product's capability to provide safe and effective contraception that rivals the current 5-year LNG-subdermal implant. The findings provide valuable information for policy makers, family planning programmers and clinicians that the ENG-releasing subdermal implant is still highly effective up to 5 years after insertion. Compared to previous efforts, our study population was geographically diverse and our study had the highest number of participants completing at least 5 years of use. Trial registration The trial was registered as ISRCTN33378571. Study funding/competing interests The contraceptive devices and funds for conduct of the study were provided by the United Nations Development Programme/United Nations Population Fund/World Health Organization (WHO)/UNICEF/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), WHO. This report contains the collective views of an international group of experts, and does not necessarily represent the decisions or the stated policy of the WHO. All stated authors have no conflict of interest, except Dr Hubacher who reported grants from United States Agency for International Development, during the conduct of the study; other from Advisory Boards (Teva, Bayer, OCON), outside the submitted work.

  • a 3 year multicentre randomized controlled trial of etonogestrel and levonorgestrel releasing contraceptive implants with non randomized matched copper intrauterine device controls
    Human Reproduction, 2015
    Co-Authors: Luis Bahamondes, Moazzam Ali, Vivian Brache, Ndema Habib, O Meirik, Sihem Landoulsi
    Abstract:

    STUDY QUESTION: Is there any difference in the clinical performance of the 3-year one-rod etonogestrel (ENG)- and the 5-year two-rod levonorgestrel (LNG)-releasing contraceptive implants during 3 years of insertion and between implant and intrauterine device (IUD) contraception in particular complaints possibly related to hormonal contraceptives? SUMMARY ANSWER: The cumulative contraceptive effectiveness after 3 years and method continuation through 2.5 years were not significantly different between ENG and LNG implants but both outcomes were significantly worse in the non-randomized age-matched group of IUD users than in the combined implant group. WHAT IS KNOWN ALREADY: ENG- and LNG-releasing implants are safe and highly efficacious contraceptives with pregnancy rates reported to be 0.0-0.5 per 100 women-years (W-Y). No head-to-head comparative study of the two implants has been undertaken and little information is available on comparisons of complaints of side effects of implant and copper IUD users. STUDY DESIGN SIZE DURATION: This was an open parallel group RCT with 1:1 allocation ratio of the ENG and the LNG implants with non-randomized control group of women choosing TCu380A IUD to address lack of reliable data on common side effects typically attributed to the use of progestogen-only contraceptives. After device(s) placement follow-ups were at 2 weeks 3 and 6 months and semi-annually thereafter for 3 years or until pregnancy removal or expulsion of the implant/IUD occurred. PARTICIPANTS SETTING METHODS: The study took place in family planning clinics in Brazil Chile Dominican Republic Hungary Thailand Turkey and Zimbabwe. Women seeking long-term contraception were enlisted after an eligibility check and informed consent and 2982 women were enrolled: 1003 1005 and 974 in the ENG-implant LNG-implant and IUD groups respectively; 995 997 and 971 respectively were included in the per protocol analysis reported here. MAIN RESULTS AND THE ROLE OF CHANCE: ENG and LNG implants each had the same 3-year cumulative pregnancy rate of 0.4 per 100 W-Y [95% confidence interval (CI) 0.1-1.4]. A weight of >/=70 kg at admission was unrelated to pregnancy. Method continuation rates for ENG and LNG implants at 2.5 years were 69.8 (95% CI 66.8-72.6) and 71.8 per 100 W-Y (68.8-74.5) and at 3 years 12.1 (95% CI 5.2-22.0) and 52.0 per 100 W-Y (95% CI 41.8-61.2) respectively. Bleeding disturbances the most frequent reason for method discontinuation were significantly more common in the ENG group [16.7 (95% CI 14.4-19.3)] than in the LNG group [12.5 (95% CI 10.5-14.9)] (P 0.019). The 3-year cumulative loss to follow-up was lower in the ENG- than in the LNG-implant group 8.1 (95% CI 6.4-10.2) and 14.4 per 100 W-Y (95% CI 12.1-17.1) respectively. The median duration of implant removal was 50 s shorter among women with ENG than among women with LNG implant (P /=70 kg was <20% and <8% were obese. WIDER IMPLICATIONS OF THE FINDINGS: Findings of the study can inform policy makers and clinicians about choice of implant but also about TCu380A IUD in relation to implants. STUDY FUNDING/COMPETING INTERESTS: UNDP/UNFPA/WHO/UNICEF/World Bank Special Programme of Research Development and Research Training in Human Reproduction (HRP) Department of Reproductive Health and Research (RHR) World Health Organization (WHO). This report contains the views of an international expert group and does not necessarily represent the decisions or the stated policy of the WHO. TRIAL REGISTRATION: ISRCTN33378571 registered on 22 March 2004. The first participant was enrolled on 12 May 2003. (c) The Author 2015. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions please email: journals.permissions@oup.com.

Sihem Landoulsi - One of the best experts on this subject based on the ideXlab platform.

  • extended use up to 5 years of the etonogestrel releasing subdermal contraceptive implant comparison to levonorgestrel releasing subdermal implant
    Human Reproduction, 2016
    Co-Authors: Moazzam Ali, Luis Bahamondes, Sihem Landoulsi, Ayse Akin, Vivian Brache, Ndema Habib, David Hubacher
    Abstract:

    Study question Is it possible to extend the use of the 3-year one-rod etonogestrel (ENG)-releasing subdermal contraceptive implant to 5 years? Summary answer The extended use of the one-rod ENG-releasing subdermal contraceptive implant showed 100% efficacy in years 4 and 5. What is known already The initial regulated trials on the ENG-releasing subdermal contraceptive implant conducted in the 1990 s were designed to measure cumulative 3-year efficacy. The ENG-implant has both well established safety and efficacy for up to 3 years. Pharmacokinetic data on ENG show high levels at 3 years and some previous clinical research confirms efficacy beyond the current approved duration of 3 years. Today, many women, because the labeled duration has been reached, have the ENG implant removed at 3 years, increasing costs, inconvenience and risks. Study design size, duration For the first 3 years, this study was an open-label, multi-centre randomized trial comparing the 3-year ENG implant to the 5-year levonorgestrel (LNG)-releasing implant. After 3 years, a subset of 390 ENG participants, consented to extended use. We compared efficacy, side effects and removal procedures of both implants. We used Kaplan-Meier (K-M) analysis. We included an observational cohort of copper intrauterine device (IUD) users as non-users of hormonal contraceptive method for comparative purposes. Participants/materials, setting, methods The study took place in family planning clinics in seven countries worldwide. Women were enlisted after an eligibility check and informed consent, and 1328 women were enrolled: 390, 522 and 416 in the ENG-implant, LNG-implant and IUD groups, respectively. Main results and the role of chance Over 200 women used the ENG implant for at least 5 years. No pregnancies occurred during the additional 2 years of follow up in the ENG or LNG implant group. The overall 5-year K-M cumulative pregnancy rates for ENG- and LNG- implants were 0.6 per 100 women-years (W-Y) [95% confidence interval (CI): 0.2-1.8] and 0.8 per 100 W-Y [95% CI: 0.2-2.3], respectively. Complaints of bleeding changes were similar; however, ENG-users were more likely than LNG-users to experience heavy bleeding (p Limitations, reasons for caution Few women were ≤19 years old or nulligravida. Although there was no weight limit for enrolment in the study, the number of women ≥70 kg were few. Wider implications of the findings The results from this study corroborate previous evidence showing high contraceptive efficacy through 4 years for the ENG-implant. Data through 5 years are a novel contribution and further proof of the product's capability to provide safe and effective contraception that rivals the current 5-year LNG-subdermal implant. The findings provide valuable information for policy makers, family planning programmers and clinicians that the ENG-releasing subdermal implant is still highly effective up to 5 years after insertion. Compared to previous efforts, our study population was geographically diverse and our study had the highest number of participants completing at least 5 years of use. Trial registration The trial was registered as ISRCTN33378571. Study funding/competing interests The contraceptive devices and funds for conduct of the study were provided by the United Nations Development Programme/United Nations Population Fund/World Health Organization (WHO)/UNICEF/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), WHO. This report contains the collective views of an international group of experts, and does not necessarily represent the decisions or the stated policy of the WHO. All stated authors have no conflict of interest, except Dr Hubacher who reported grants from United States Agency for International Development, during the conduct of the study; other from Advisory Boards (Teva, Bayer, OCON), outside the submitted work.

  • a 3 year multicentre randomized controlled trial of etonogestrel and levonorgestrel releasing contraceptive implants with non randomized matched copper intrauterine device controls
    Human Reproduction, 2015
    Co-Authors: Luis Bahamondes, Moazzam Ali, Vivian Brache, Ndema Habib, O Meirik, Sihem Landoulsi
    Abstract:

    STUDY QUESTION: Is there any difference in the clinical performance of the 3-year one-rod etonogestrel (ENG)- and the 5-year two-rod levonorgestrel (LNG)-releasing contraceptive implants during 3 years of insertion and between implant and intrauterine device (IUD) contraception in particular complaints possibly related to hormonal contraceptives? SUMMARY ANSWER: The cumulative contraceptive effectiveness after 3 years and method continuation through 2.5 years were not significantly different between ENG and LNG implants but both outcomes were significantly worse in the non-randomized age-matched group of IUD users than in the combined implant group. WHAT IS KNOWN ALREADY: ENG- and LNG-releasing implants are safe and highly efficacious contraceptives with pregnancy rates reported to be 0.0-0.5 per 100 women-years (W-Y). No head-to-head comparative study of the two implants has been undertaken and little information is available on comparisons of complaints of side effects of implant and copper IUD users. STUDY DESIGN SIZE DURATION: This was an open parallel group RCT with 1:1 allocation ratio of the ENG and the LNG implants with non-randomized control group of women choosing TCu380A IUD to address lack of reliable data on common side effects typically attributed to the use of progestogen-only contraceptives. After device(s) placement follow-ups were at 2 weeks 3 and 6 months and semi-annually thereafter for 3 years or until pregnancy removal or expulsion of the implant/IUD occurred. PARTICIPANTS SETTING METHODS: The study took place in family planning clinics in Brazil Chile Dominican Republic Hungary Thailand Turkey and Zimbabwe. Women seeking long-term contraception were enlisted after an eligibility check and informed consent and 2982 women were enrolled: 1003 1005 and 974 in the ENG-implant LNG-implant and IUD groups respectively; 995 997 and 971 respectively were included in the per protocol analysis reported here. MAIN RESULTS AND THE ROLE OF CHANCE: ENG and LNG implants each had the same 3-year cumulative pregnancy rate of 0.4 per 100 W-Y [95% confidence interval (CI) 0.1-1.4]. A weight of >/=70 kg at admission was unrelated to pregnancy. Method continuation rates for ENG and LNG implants at 2.5 years were 69.8 (95% CI 66.8-72.6) and 71.8 per 100 W-Y (68.8-74.5) and at 3 years 12.1 (95% CI 5.2-22.0) and 52.0 per 100 W-Y (95% CI 41.8-61.2) respectively. Bleeding disturbances the most frequent reason for method discontinuation were significantly more common in the ENG group [16.7 (95% CI 14.4-19.3)] than in the LNG group [12.5 (95% CI 10.5-14.9)] (P 0.019). The 3-year cumulative loss to follow-up was lower in the ENG- than in the LNG-implant group 8.1 (95% CI 6.4-10.2) and 14.4 per 100 W-Y (95% CI 12.1-17.1) respectively. The median duration of implant removal was 50 s shorter among women with ENG than among women with LNG implant (P /=70 kg was <20% and <8% were obese. WIDER IMPLICATIONS OF THE FINDINGS: Findings of the study can inform policy makers and clinicians about choice of implant but also about TCu380A IUD in relation to implants. STUDY FUNDING/COMPETING INTERESTS: UNDP/UNFPA/WHO/UNICEF/World Bank Special Programme of Research Development and Research Training in Human Reproduction (HRP) Department of Reproductive Health and Research (RHR) World Health Organization (WHO). This report contains the views of an international expert group and does not necessarily represent the decisions or the stated policy of the WHO. TRIAL REGISTRATION: ISRCTN33378571 registered on 22 March 2004. The first participant was enrolled on 12 May 2003. (c) The Author 2015. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions please email: journals.permissions@oup.com.