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Jeffrey F Peipert - One of the best experts on this subject based on the ideXlab platform.
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prolonged use of the Etonogestrel implant and levonorgestrel intrauterine device 2 years beyond food and drug administration approved duration
American Journal of Obstetrics and Gynecology, 2017Co-Authors: Erin Swor, Jeffrey F PeipertAbstract:Background The subdermal contraceptive implant and the 52-mg levonorgestrel intrauterine device are currently Food and Drug Administration approved for 3 and 5 years of use, respectively. Limited available data suggested both of these methods are effective beyond that time. Demonstration of prolonged effectiveness will improve the cost-effectiveness of the device, and potentially patient continuation and satisfaction. Objective We sought to evaluate the effectiveness of the contraceptive implant and the 52-mg hormonal intrauterine device in women using the method for 2 years beyond the current Food and Drug Administration–approved duration. Study Design We initiated this ongoing prospective cohort study in January 2012. We are enrolling women using the contraceptive implant or 52-mg levonorgestrel intrauterine device for a minimum of 3 and 5 years, respectively (started intrauterine device in ≥2007 or implant in ≥2009). Demographic and reproductive health histories, as well as objective body mass index, were collected. Implant users were offered periodic venipuncture for analysis of serum Etonogestrel levels. The primary outcome, unintended pregnancy rate, was calculated per 100 woman-years. We analyzed baseline demographic characteristics using χ 2 test and Fisher exact test, and compared serum Etonogestrel levels stratified by body mass index using the Kruskal-Wallis test. Results Implant users (n = 291) have contributed 444.0 woman-years of follow-up. There have been no documented pregnancies in implant users during the 2 years of postexpiration follow-up. Calculated failure rates in the fourth and fifth years for the implant are calculated as 0 (1-sided 97.5% confidence interval, 0–1.48) per 100 woman-years at 4 years and 0 (1-sided 97.5% confidence interval, 0–2.65) per 100 woman-years at 5 years. Among 496 levonorgestrel intrauterine device users, 696.9 woman-years of follow-up have been completed. Two pregnancies have been reported. The failure rate in the sixth year of use of the levonorgestrel intrauterine device is calculated as 0.25 (95% confidence interval, 0.04–1.42) per 100 woman-years; failure rate during the seventh year is 0.43 (95% confidence interval, 0.08–2.39) per 100 woman-years. Among implant users with serum Etonogestrel results, the median Etonogestrel level was 207.7 pg/mL (range 63.8-802.6 pg/mL) at the time of method expiration, 166.1 pg/mL (range 67.9 25.0–470.5 pg/mL) at the end of the fourth year, and 153.0 pg/mL (range 72.1-538.8 pg/mL) at the end of the fifth year. Median Etonogestrel levels were compared by body mass index at each time point and a statistical difference was noted at the end of 4 years of use with overweight women having the highest serum Etonogestrel (195.9; range 25.0-450.5 pg/mL) when compared to normal (178.9; range 87.0-463.7 pg/mL) and obese (137.9; range 66.0-470.5 pg/mL) women ( P = .04). Conclusion This study indicates that the contraceptive implant and 52-mg hormonal intrauterine device continue to be highly effective for at least 2 additional years of use. Serum Etonogestrel evaluation demonstrates median levels remain above the ovulation threshold of 90 pg/mL for women in all body mass index classes.
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use of the Etonogestrel implant and levonorgestrel intrauterine device beyond the u s food and drug administration approved duration
Obstetrics & Gynecology, 2015Co-Authors: Colleen Mcnicholas, Erin Swor, Ragini Maddipati, Qiuhong Zhao, Jeffrey F PeipertAbstract:OBJECTIVE: To evaluate the effectiveness of the contraceptive implant and the 52-mg hormonal intrauterine device (IUD) in women using the method beyond the current U.S. Food and Drug Administration (FDA)-approved duration of 3 and 5 years respectively. METHODS: Women willing to continue using their implant or 52-mg levonorgestrel IUD beyond the FDA-approved duration were followed prospectively for contraceptive effectiveness. Unintended pregnancy rate per 100 women-years was calculated. Implant users are offered periodic venipuncture for analysis of serum Etonogestrel levels. The Kruskal-Wallis test was used to compare the Etonogestrel levels across body mass index (BMI) groups. RESULTS: Implant users (n=237) have contributed 229.4 women-years of follow-up with 123 using the Etonogestrel implant for 4 years and 34 using it for 5 years. Zero pregnancies have been documented for a failure rate of 0 (one-sided 97.5% confidence interval [CI] 0-1.61) per 100 women-years. Among 263 levonorgestrel IUD users 197.7 women-years of follow-up have been completed. One pregnancy was confirmed for a failure rate of 0.51 (95% CI 0.01-2.82) per 100 women-years. Among implant users with serum Etonogestrel results the median and range of Etonogestrel level at 3 years of use was 188.8 pg/mL (range 63.8-802.6 pg/mL) and 177.0 pg/mL (67.9-470.5 pg/mL) at 4 years of use. Etonogestrel levels did not differ by BMI at either time point (3 years: P=.79; 4 years: P=.47). CONCLUSION: Preliminary findings indicate the contraceptive implant and 52-mg hormonal IUD continue to be highly effective for an additional year beyond the FDA-approved 3 and 5 years. Serum Etonogestrel levels indicate the implant contains adequate hormone for ovulation suppression at the end of both 3 and 4 years of use. LEVEL OF EVIDENCE: II.
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use of the Etonogestrel releasing contraceptive implant
Expert Review of Obstetrics & Gynecology, 2013Co-Authors: Jaclyn M Grentzer, Colleen Mcnicholas, Jeffrey F PeipertAbstract:The single-rod, Etonogestrel-releasing, subdermal implant (ENG implant) is the most effective, long-acting reversible method of contraception available. The failure rate of the ENG implant is 0.05%, which makes it more effective than female sterilization. It is discreet, easy to insert and remove, has no effect on future fertility and is associated with a number of noncontraceptive health benefits. The ENG implant is safe and effective when used in the postpartum and postabortion setting, and in women who have contraindications to estrogen. The most common reason cited for discontinuation is irregular and unpredictable bleeding. However, structured, preinsertion counseling can increase continuation and user satisfaction.
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continuation of the Etonogestrel implant in women undergoing immediate postabortion placement
Contraception, 2012Co-Authors: Tessa Madden, Qiuhong Zhao, David L Eisenberg, Christina Buckel, Gina M Secura, Jeffrey F PeipertAbstract:Objective To estimate whether women who receive an immediate postabortion Etonogestrel subdermal implant have higher discontinuation rates than women who undergo an interval insertion (insertion not associated with a recent pregnancy).
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contraceptive failure rates of Etonogestrel subdermal implants in overweight and obese women
Obstetrics & Gynecology, 2012Co-Authors: Jennifer A Wade, Jeffrey F Peipert, Tessa Madden, Qiuhong Zhao, Gina M SecuraAbstract:Objective To estimate the contraceptive failure rates of the Etonogestrel subdermal contraceptive implant in overweight and obese women, and compare failure rates to women of normal weight and women using intrauterine devices (IUDs).
Maryam Guiahi - One of the best experts on this subject based on the ideXlab platform.
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a pilot study on the effect of isotretinoin on serum Etonogestrel concentrations in contraceptive implant users
Contraception, 2020Co-Authors: Aaron Lazorwitz, Anne R Davis, Rebecca A Seale, Maryam GuiahiAbstract:Abstract Objective To explore the pharmacokinetic interaction between isotretinoin, a cytochrome P-450 (CYP) inducer and potent teratogen, and the Etonogestrel contraceptive implant. Study design We enrolled healthy reproductive-age women initiating isotretinoin and using an Etonogestrel implant. We compared serum Etonogestrel concentrations at baseline and after four and nine weeks of isotretinoin co-administration using a validated assay. Results Among eight implant users, all serum Etonogestrel concentrations remained >90 pg/mL during isotretinoin co-administration with no significant changes from baseline (p = 0.25, Friedman’s test). Conclusion In this exploratory study, we found that isotretinoin did not cause serum Etonogestrel concentrations to fall below the threshold for ovulatory suppression ( Implications Reproductive-age women treated with isotretinoin require reliable contraception to prevent pregnancies impacted by teratogenic-effects. This small study demonstrates that contraceptive implant users maintained serum Etonogestrel concentrations above the threshold for consistent ovulatory suppression during isotretinoin co-administration. The contraceptive implant remains an appropriate option for patients considering isotretinoin therapy.
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relationship between patient characteristics and serum Etonogestrel concentrations in contraceptive implant users
Contraception, 2019Co-Authors: Aaron Lazorwitz, Maryam Guiahi, Christina L Aquilante, Jeanelle Sheeder, Stephanie B TealAbstract:Abstract Objective To determine whether serum Etonogestrel concentrations in contraceptive implant users are associated with certain individual patient characteristics. Study design We enrolled reproductive-age women using Etonogestrel contraceptive implants between 12–36 months duration and measured a single serum Etonogestrel concentration. Participants also completed a questionnaire about demographics. Results We enrolled 350 participants; median age was 22.5 years (range 18.0–39.1), median months of implant use was 26.0 (range 12.0–36.0), and median body mass index was 25.7 kg/m2 (range 18.5–52.0). Our study population was primarily white/Caucasian (46.6% [163/350]) and Hispanic/Latina ethnicity (51.4% [180/350]). The median serum Etonogestrel concentration was 137.4 pg/ml and Etonogestrel concentrations varied 12.4 fold in the population (range 55.8–695.1 pg/ml). Using forward stepwise linear regression, months of implant use (β=−1.74, p Conclusions Individuals demonstrated a wide variability in serum Etonogestrel concentrations, which can potentially affect side-effect profiles and efficacy. Increasing body mass index and longer duration of implant use were associated with small decreases in serum Etonogestrel concentrations, while self-reported Black/African American race was associated with a non-significant increase. Despite these findings, most of Etonogestrel variability was unaccounted for, suggesting that other clinical, pharmacologic, and genetic factors contributing to variability in Etonogestrel concentrations remain to be determined. Implications Although increases in body mass index are associated with lower Etonogestrel levels in contraceptive implant users, the majority of women will maintain serum concentrations that consistently suppress ovulation. Furthermore, certain patient characteristics can only explain a small portion (13%) of the variability in serum Etonogestrel levels among contraceptive implant users.
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influence of genetic variants on steady state Etonogestrel concentrations among contraceptive implant users
Obstetrics & Gynecology, 2019Co-Authors: Aaron Lazorwitz, Maryam Guiahi, Christina L Aquilante, Kris Oreschak, Jeanelle Sheeder, Stephanie B TealAbstract:OBJECTIVE:To identify genetic variants that influence steady-state Etonogestrel concentrations among contraceptive implant users.METHODS:We enrolled healthy, reproductive-age women in our pharmacogenomic study using Etonogestrel implants for 12–36 months without concomitant use of hepatic enzyme ind
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the effect of carbamazepine on Etonogestrel concentrations in contraceptive implant users
Contraception, 2016Co-Authors: Aaron Lazorwitz, Anne R Davis, Maryke Swartz, Maryam GuiahiAbstract:Abstract Objective The objective was to determine the impact of carbamazepine on the pharmacokinetics and pharmacodynamics of the Etonogestrel contraceptive implant. Study design We enrolled healthy, reproductive-age women using an Etonogestrel implant for 1–3 years. We measured Etonogestrel levels at baseline and following 3 weeks of coadministered carbamazepine titrated up to 300 mg twice daily. We also evaluated for ovarian follicle-like structures and endometrial thickness using transvaginal ultrasound at the baseline and 3-week visits. Results We enrolled 13 women; 10 completed study procedures. Participants' mean age was 25.6 years (±5.6), mean body mass index was 30.4 (±7.3), and median duration of implant use was 23 months (range 15–35). The median Etonogestrel concentrations before and after carbamazepine coadministration were 158.1 pg/mL (range 128–347) and 50.9 pg/mL (range 39–202), respectively (p=.005). In 8 of 10 subjects, the Etonogestrel concentration was below the threshold for ovulatory suppression ( Conclusions Women using a contraceptive implant experienced significant reductions in Etonogestrel concentrations following coadministration of 600 mg of carbamazepine. We did not find significant pharmacodynamic changes during this abbreviated follow-up period. Implications Carbamazepine use significantly reduces serum Etonogestrel concentrations in women using an Etonogestrel contraceptive implant, with the majority of participants having Etonogestrel concentrations below the threshold for ovulatory suppression. Our findings suggest that treatment with carbamazepine might increase the risk of pregnancy in Etonogestrel implant users.
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short term treatment of bothersome bleeding for Etonogestrel implant users using a 14 day oral contraceptive pill regimen a randomized controlled trial
Obstetrics & Gynecology, 2015Co-Authors: Maryam Guiahi, Jeanelle Sheeder, Madeline Mcbride, Stephanie B TealAbstract:OBJECTIVE: To understand whether using oral contraceptive pills (OCPs) results in temporary interruption of bleeding for Etonogestrel contraceptive implant users during a 14-day course. METHODS: In this double-blind trial we randomly assigned Etonogestrel implant users reporting 7 consecutive days or more of bothersome bleeding to receive 14 pills of study drug (150 microgram levonorgestrel and 30 microgram ethinyl estradiol combined OCPs) or an identical-appearing placebo. The primary outcome was the proportion of women in each group who stopped bleeding during therapy and continued to report no bleeding at the end of therapy. Prespecified secondary outcomes were number of days until temporary interruption of bleeding occurred number of days without bleeding during therapy and number of days to recurrence of bleeding after discontinuation of therapy. We hypothesized that temporary interruption of bleeding would occur in 80% of the treatment group compared with 20% in the control group; using 80% power we needed a sample size of 26 women. We performed intent-to-treat analysis. RESULTS: From November 2013 through December 2014 66 women were screened and 32 were randomized: OCPs (n=16) or placebo (n=16). The majority was young Caucasian women with reported bleeding as extremely or very annoying; groups had similar baseline characteristics. Participants randomized OCPs were more likely (14 of 16 [87.5%+/-16.2%] compared with six of 16 [37.5%+/-23.7%]) to have a temporary interruption of bleeding during the study drug period (odds ratio 11.7 95% confidence interval 1.9-70.2). Of women in the OCP arm who had a temporary interruption 85.7% had bleeding recurrence within 10 days after treatment. CONCLUSION: Bothersome bleeding in Etonogestrel contraceptive implant users will usually stop with 14-day OCP treatment but bleeding most often resumes within days of treatment cessation. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov www.clinicaltrials.gov NCT01968135. LEVEL OF EVIDENCE: I.
Stephanie B Teal - One of the best experts on this subject based on the ideXlab platform.
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relationship between Etonogestrel concentrations and bleeding patterns in contraceptive implant users
Obstetrics & Gynecology, 2019Co-Authors: Aaron Lazorwitz, Christina L Aquilante, Jeanelle Sheeder, Eva Dindinger, Margaret J Harrison, Stephanie B TealAbstract:OBJECTIVE:To estimate whether serum Etonogestrel concentrations influence bleeding patterns and related side effects in contraceptive implant users.METHODS:We conducted a prospective cross-sectional study with healthy, reproductive-aged women using Etonogestrel implants for 12–36 months. Participant
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relationship between patient characteristics and serum Etonogestrel concentrations in contraceptive implant users
Contraception, 2019Co-Authors: Aaron Lazorwitz, Maryam Guiahi, Christina L Aquilante, Jeanelle Sheeder, Stephanie B TealAbstract:Abstract Objective To determine whether serum Etonogestrel concentrations in contraceptive implant users are associated with certain individual patient characteristics. Study design We enrolled reproductive-age women using Etonogestrel contraceptive implants between 12–36 months duration and measured a single serum Etonogestrel concentration. Participants also completed a questionnaire about demographics. Results We enrolled 350 participants; median age was 22.5 years (range 18.0–39.1), median months of implant use was 26.0 (range 12.0–36.0), and median body mass index was 25.7 kg/m2 (range 18.5–52.0). Our study population was primarily white/Caucasian (46.6% [163/350]) and Hispanic/Latina ethnicity (51.4% [180/350]). The median serum Etonogestrel concentration was 137.4 pg/ml and Etonogestrel concentrations varied 12.4 fold in the population (range 55.8–695.1 pg/ml). Using forward stepwise linear regression, months of implant use (β=−1.74, p Conclusions Individuals demonstrated a wide variability in serum Etonogestrel concentrations, which can potentially affect side-effect profiles and efficacy. Increasing body mass index and longer duration of implant use were associated with small decreases in serum Etonogestrel concentrations, while self-reported Black/African American race was associated with a non-significant increase. Despite these findings, most of Etonogestrel variability was unaccounted for, suggesting that other clinical, pharmacologic, and genetic factors contributing to variability in Etonogestrel concentrations remain to be determined. Implications Although increases in body mass index are associated with lower Etonogestrel levels in contraceptive implant users, the majority of women will maintain serum concentrations that consistently suppress ovulation. Furthermore, certain patient characteristics can only explain a small portion (13%) of the variability in serum Etonogestrel levels among contraceptive implant users.
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influence of genetic variants on steady state Etonogestrel concentrations among contraceptive implant users
Obstetrics & Gynecology, 2019Co-Authors: Aaron Lazorwitz, Maryam Guiahi, Christina L Aquilante, Kris Oreschak, Jeanelle Sheeder, Stephanie B TealAbstract:OBJECTIVE:To identify genetic variants that influence steady-state Etonogestrel concentrations among contraceptive implant users.METHODS:We enrolled healthy, reproductive-age women in our pharmacogenomic study using Etonogestrel implants for 12–36 months without concomitant use of hepatic enzyme ind
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short term treatment of bothersome bleeding for Etonogestrel implant users using a 14 day oral contraceptive pill regimen a randomized controlled trial
Obstetrics & Gynecology, 2015Co-Authors: Maryam Guiahi, Jeanelle Sheeder, Madeline Mcbride, Stephanie B TealAbstract:OBJECTIVE: To understand whether using oral contraceptive pills (OCPs) results in temporary interruption of bleeding for Etonogestrel contraceptive implant users during a 14-day course. METHODS: In this double-blind trial we randomly assigned Etonogestrel implant users reporting 7 consecutive days or more of bothersome bleeding to receive 14 pills of study drug (150 microgram levonorgestrel and 30 microgram ethinyl estradiol combined OCPs) or an identical-appearing placebo. The primary outcome was the proportion of women in each group who stopped bleeding during therapy and continued to report no bleeding at the end of therapy. Prespecified secondary outcomes were number of days until temporary interruption of bleeding occurred number of days without bleeding during therapy and number of days to recurrence of bleeding after discontinuation of therapy. We hypothesized that temporary interruption of bleeding would occur in 80% of the treatment group compared with 20% in the control group; using 80% power we needed a sample size of 26 women. We performed intent-to-treat analysis. RESULTS: From November 2013 through December 2014 66 women were screened and 32 were randomized: OCPs (n=16) or placebo (n=16). The majority was young Caucasian women with reported bleeding as extremely or very annoying; groups had similar baseline characteristics. Participants randomized OCPs were more likely (14 of 16 [87.5%+/-16.2%] compared with six of 16 [37.5%+/-23.7%]) to have a temporary interruption of bleeding during the study drug period (odds ratio 11.7 95% confidence interval 1.9-70.2). Of women in the OCP arm who had a temporary interruption 85.7% had bleeding recurrence within 10 days after treatment. CONCLUSION: Bothersome bleeding in Etonogestrel contraceptive implant users will usually stop with 14-day OCP treatment but bleeding most often resumes within days of treatment cessation. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov www.clinicaltrials.gov NCT01968135. LEVEL OF EVIDENCE: I.
Aaron Lazorwitz - One of the best experts on this subject based on the ideXlab platform.
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a pilot study on the effect of isotretinoin on serum Etonogestrel concentrations in contraceptive implant users
Contraception, 2020Co-Authors: Aaron Lazorwitz, Anne R Davis, Rebecca A Seale, Maryam GuiahiAbstract:Abstract Objective To explore the pharmacokinetic interaction between isotretinoin, a cytochrome P-450 (CYP) inducer and potent teratogen, and the Etonogestrel contraceptive implant. Study design We enrolled healthy reproductive-age women initiating isotretinoin and using an Etonogestrel implant. We compared serum Etonogestrel concentrations at baseline and after four and nine weeks of isotretinoin co-administration using a validated assay. Results Among eight implant users, all serum Etonogestrel concentrations remained >90 pg/mL during isotretinoin co-administration with no significant changes from baseline (p = 0.25, Friedman’s test). Conclusion In this exploratory study, we found that isotretinoin did not cause serum Etonogestrel concentrations to fall below the threshold for ovulatory suppression ( Implications Reproductive-age women treated with isotretinoin require reliable contraception to prevent pregnancies impacted by teratogenic-effects. This small study demonstrates that contraceptive implant users maintained serum Etonogestrel concentrations above the threshold for consistent ovulatory suppression during isotretinoin co-administration. The contraceptive implant remains an appropriate option for patients considering isotretinoin therapy.
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relationship between Etonogestrel concentrations and bleeding patterns in contraceptive implant users
Obstetrics & Gynecology, 2019Co-Authors: Aaron Lazorwitz, Christina L Aquilante, Jeanelle Sheeder, Eva Dindinger, Margaret J Harrison, Stephanie B TealAbstract:OBJECTIVE:To estimate whether serum Etonogestrel concentrations influence bleeding patterns and related side effects in contraceptive implant users.METHODS:We conducted a prospective cross-sectional study with healthy, reproductive-aged women using Etonogestrel implants for 12–36 months. Participant
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relationship between patient characteristics and serum Etonogestrel concentrations in contraceptive implant users
Contraception, 2019Co-Authors: Aaron Lazorwitz, Maryam Guiahi, Christina L Aquilante, Jeanelle Sheeder, Stephanie B TealAbstract:Abstract Objective To determine whether serum Etonogestrel concentrations in contraceptive implant users are associated with certain individual patient characteristics. Study design We enrolled reproductive-age women using Etonogestrel contraceptive implants between 12–36 months duration and measured a single serum Etonogestrel concentration. Participants also completed a questionnaire about demographics. Results We enrolled 350 participants; median age was 22.5 years (range 18.0–39.1), median months of implant use was 26.0 (range 12.0–36.0), and median body mass index was 25.7 kg/m2 (range 18.5–52.0). Our study population was primarily white/Caucasian (46.6% [163/350]) and Hispanic/Latina ethnicity (51.4% [180/350]). The median serum Etonogestrel concentration was 137.4 pg/ml and Etonogestrel concentrations varied 12.4 fold in the population (range 55.8–695.1 pg/ml). Using forward stepwise linear regression, months of implant use (β=−1.74, p Conclusions Individuals demonstrated a wide variability in serum Etonogestrel concentrations, which can potentially affect side-effect profiles and efficacy. Increasing body mass index and longer duration of implant use were associated with small decreases in serum Etonogestrel concentrations, while self-reported Black/African American race was associated with a non-significant increase. Despite these findings, most of Etonogestrel variability was unaccounted for, suggesting that other clinical, pharmacologic, and genetic factors contributing to variability in Etonogestrel concentrations remain to be determined. Implications Although increases in body mass index are associated with lower Etonogestrel levels in contraceptive implant users, the majority of women will maintain serum concentrations that consistently suppress ovulation. Furthermore, certain patient characteristics can only explain a small portion (13%) of the variability in serum Etonogestrel levels among contraceptive implant users.
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influence of genetic variants on steady state Etonogestrel concentrations among contraceptive implant users
Obstetrics & Gynecology, 2019Co-Authors: Aaron Lazorwitz, Maryam Guiahi, Christina L Aquilante, Kris Oreschak, Jeanelle Sheeder, Stephanie B TealAbstract:OBJECTIVE:To identify genetic variants that influence steady-state Etonogestrel concentrations among contraceptive implant users.METHODS:We enrolled healthy, reproductive-age women in our pharmacogenomic study using Etonogestrel implants for 12–36 months without concomitant use of hepatic enzyme ind
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the effect of carbamazepine on Etonogestrel concentrations in contraceptive implant users
Contraception, 2016Co-Authors: Aaron Lazorwitz, Anne R Davis, Maryke Swartz, Maryam GuiahiAbstract:Abstract Objective The objective was to determine the impact of carbamazepine on the pharmacokinetics and pharmacodynamics of the Etonogestrel contraceptive implant. Study design We enrolled healthy, reproductive-age women using an Etonogestrel implant for 1–3 years. We measured Etonogestrel levels at baseline and following 3 weeks of coadministered carbamazepine titrated up to 300 mg twice daily. We also evaluated for ovarian follicle-like structures and endometrial thickness using transvaginal ultrasound at the baseline and 3-week visits. Results We enrolled 13 women; 10 completed study procedures. Participants' mean age was 25.6 years (±5.6), mean body mass index was 30.4 (±7.3), and median duration of implant use was 23 months (range 15–35). The median Etonogestrel concentrations before and after carbamazepine coadministration were 158.1 pg/mL (range 128–347) and 50.9 pg/mL (range 39–202), respectively (p=.005). In 8 of 10 subjects, the Etonogestrel concentration was below the threshold for ovulatory suppression ( Conclusions Women using a contraceptive implant experienced significant reductions in Etonogestrel concentrations following coadministration of 600 mg of carbamazepine. We did not find significant pharmacodynamic changes during this abbreviated follow-up period. Implications Carbamazepine use significantly reduces serum Etonogestrel concentrations in women using an Etonogestrel contraceptive implant, with the majority of participants having Etonogestrel concentrations below the threshold for ovulatory suppression. Our findings suggest that treatment with carbamazepine might increase the risk of pregnancy in Etonogestrel implant users.
Mitchell D. Creinin - One of the best experts on this subject based on the ideXlab platform.
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best practices for counseling adolescents about the Etonogestrel implant
Journal of Pediatric and Adolescent Gynecology, 2020Co-Authors: Elise D Berlan, Mitchell D. Creinin, Andrew M Kaunitz, Ian S. Fraser, Molly Richards, Carolina Sales Vieira, Alison Edelman, Diana MansourAbstract:Among young persons, ease of use, high efficacy, and high acceptability makes the Etonogestrel contraceptive implant an important choice for this age group. Adolescent-friendly, patient-centered counseling considers the patient's cognitive development, the influence of friends and family, as well as their own preferences and values. Age-appropriate language, graphics, and models are useful to explain contraceptive options and relevant side effects. Effectiveness, reversibility, safety, noncontraceptive benefits, and side effects are important attributes and should be discussed when teens are choosing a contraceptive method. In this review we describe suggested best practices for counseling adolescents about the Etonogestrel implant so they can make informed, prudent decisions about using this contraceptive method.
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Etonogestrel implant use in women primarily choosing a combined oral contraceptive pill a proof of concept trial
Contraception, 2018Co-Authors: Melissa J Chen, Jennifer K Hsia, Mitchell D. CreininAbstract:OBJECTIVE:We evaluated a novel concept of initiating the Etonogestrel implant as a "back-up" method in women who desire using combined oral contraceptives (COC) but want to decrease their risk of unintended pregnancy with a more effective method. STUDY DESIGN:In this prospective cohort study, we planned to include 20 women as a proof-of-concept. We enrolled both new COC starters and continuing COC users and placed an Etonogestrel implant. Participants completed daily bleeding diaries and attended follow-up visits at 1, 3, and 6 months. We assessed implant continuation through six months of study participation and side effects with dual hormonal contraceptive use. RESULTS:Between September and December 2016, we enrolled 10 new starters and 10 current COC users. All participants completed 1-month follow-up, and 18 (90%) subjects completed the 3- and 6-month follow-up assessments. Two current COC users had the implant removed for mood changes before 6 months. At the 6-month follow-up visit, 10 women were using both pills and implant, seven relied on the implant only, and one was using a COC only. Three new starters chose implant removal at end of study participation; one for weight gain and acne, another for mood changes, and one for decreased libido. No subjects discontinued the implant for bleeding complaints. CONCLUSION:In this proof-of-concept study, women using COCs were willing to initiate the implant as a "back-up" method to improve pregnancy prevention. Most women continued the implant through 6 months and after completing study participation. IMPLICATIONS:Initiating the Etonogestrel implant as a "back-up" method may be an option for women who desire more effective pregnancy prevention while using combined oral contraceptive pills for its bleeding profile or non-contraceptive benefits.
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The US Etonogestrel implant mandatory clinical training and active monitoring programs: 6-year experience
Contraception, 2016Co-Authors: Mitchell D. Creinin, Philip D. Darney, Tonja W. Hampton, Lisa Schwartz, Keith Gordon, Andrew M Kaunitz, Hans RekersAbstract:Abstract Objective The objective was to monitor the effectiveness of the Etonogestrel implant clinical training program through a voluntary active monitoring program (AMP). Study design US health care providers underwent mandatory training by the manufacturer on Etonogestrel implant insertion, localization and removal. After training, health care providers could enroll in a voluntary AMP to provide outcome data to meet a postmarketing commitment of the manufacturer with the US Food and Drug Administration (FDA). Those who volunteered completed and faxed forms to the manufacturer after implant insertion and removal detailing the procedure and device-related outcomes, including insertion-, localization- or removal-associated events. Experts reviewed outcome data quarterly, which the Sponsor then reported to the FDA. Results Among 42,337 health care providers completing the training program, 4294 (10.1%) volunteered to participate in the AMP. The 26,198 forms submitted over 6.4 years included more insertion ( n =20,497) forms than removal forms ( n =5701). The volunteers reported 646 events on 566 (2.2%) forms related to insertion ( n =197), localization ( n =34), removal ( n =357) and “other” ( n =58). Clinically important events included noninsertion ( n =4), serum Etonogestrel positive but implant not found ( n =1), and possible nerve ( n =66) or vascular ( n =5) injury. The reports did not include any insertion-, localization- or removal-associated hospitalizations. Eight (0.14%) removal reports described referral for surgical implant removal. Conclusion Events related to insertion, localization or removal of the Etonogestrel implant are uncommon among US providers who received mandatory training in the use of the implant. Implications This report presents results from the first mandatory US contraceptive training program. Health care providers volunteered to report information about Etonogestrel implant insertion, localization and removal. Although the data do not demonstrate whether a mandatory program improves outcomes, they elucidate the utility and real-life experience that clinical training programs can provide.
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combined oral contraceptive treatment for bleeding complaints with the Etonogestrel contraceptive implant a randomised controlled trial
The European Journal of Contraception & Reproductive Health Care, 2016Co-Authors: Melody Y Hou, Mitchell D. CreininAbstract:AbstractObjective: Estimate symptom improvement rate of women with bleeding complaints using the Etonogestrel contraceptive implant when started on continuous combined oral contraceptives (COC).Methods: We conducted a double-blinded randomised controlled trial of women reporting troublesome bleeding related to their Etonogestrel contraceptive implant and desiring intervention. Participants received continuous COCs or placebo for four weeks to evaluate self-reported bleeding improvement at four weeks. Participants could continue study treatment or prescribed COCs for another eight weeks if desired. We planned to enroll 130 participants between two sites (80% power to detect a 20% effect size at a 0.05 significance level, with 10% loss to follow up).Results: We closed the study after enrolling 26 participants due to recruitment futility. All women on COCs and 75% of placebo users reported bleeding improvement at four weeks (p = 0.09), with 92% and 42%, respectively, reporting significant improvement (p = 0....
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removal of a nonpalpable Etonogestrel implant with preprocedure ultrasonography and modified vasectomy clamp
Obstetrics & Gynecology, 2015Co-Authors: Melissa J Chen, Mitchell D. CreininAbstract:Deep Etonogestrel contraceptive implant placements still occur despite design modifications to the implant inserter. We present a method for outpatient removal of a nonpalpable Etonogestrel implant using preprocedure ultrasonography for implant localization followed by removal with a modified vasectomy clamp, a modification of the "U" technique for six-capsule levonorgestrel implant removal.In women with a nonpalpable Etonogestrel implant containing barium sulfate, we obtain a radiographic examination to confirm the implant's presence in the upper extremity. Using an 18-MHz linear ultrasound transducer, we identify and mark the implant location on the patient's arm, noting the depth. We remove the implant with local anesthesia in the office using a modified vasectomy clamp through a 5-mm or less skin incision directly over the implant.All three patients referred to our office with nonpalpable Etonogestrel implants had successful removal using this technique.Nonpalpable contraceptive implants can be removed in the office using a modified vasectomy clamp after localization with high-frequency ultrasonography. Given the relative infrequency of nonpalpable implant removals, regional expert sites with health care providers experienced in difficult removals should be created for patient referrals.