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Thom O M Dieben - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of a contraceptive vaginal ring NuvaRing compared with a combined oral contraceptive a 1 year randomized trial
Contraception, 2005Co-Authors: Kristjan Oddsson, Carole H J Verhoeven, Beate Leifelsfischer, Nilson Roberto De Melo, Dominique Wielmasson, Chiara Benedetto, Thom O M DiebenAbstract:This open-label, randomized, Phase III study compared the efficacy and tolerability of and compliance with NuvaRing, a combined contraceptive vaginal ring releasing 15 μg of ethinylestradiol (EE) and 120 μg of etonogestrel daily, with those of and with a combined oral contraceptive (COC) containing 150 μg of levonorgestrel (LNG) and 30 μg of EE. Subjects received NuvaRing or a COC for 13 cycles (3 weeks of ring/pill treatment followed by a 1-week ring-/pill-free period). A total of 1030 subjects (NuvaRing, n=512; COC, n=518) was randomized and started treatment (intent-to-treat [ITT] population). The percentage of women in the ITT population who completed the trial was 70.9% for the NuvaRing group and 71.2% for the COC group. Five in-treatment pregnancies occurred in each group, giving Pearl indices of 1.23 for NuvaRing and 1.19 for the COC. Compliance with both treatments was excellent and both were well tolerated. In conclusion, NuvaRing has comparable efficacy and tolerability with a COC containing 150 μg of LNG and 30 μg of EE and does not require daily dosing.
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efficacy and safety of a contraceptive vaginal ring NuvaRing compared with a combined oral contraceptive a 1 year randomized trial
Contraception, 2005Co-Authors: Kristjan Oddsson, Carole H J Verhoeven, Beate Leifelsfischer, Nilson Roberto De Melo, Dominique Wielmasson, Chiara Benedetto, Thom O M DiebenAbstract:This open-label, randomized, Phase III study compared the efficacy and tolerability of and compliance with NuvaRing, a combined contraceptive vaginal ring releasing 15 μg of ethinylestradiol (EE) and 120 μg of etonogestrel daily, with those of and with a combined oral contraceptive (COC) containing 150 μg of levonorgestrel (LNG) and 30 μg of EE. Subjects received NuvaRing or a COC for 13 cycles (3 weeks of ring/pill treatment followed by a 1-week ring-/pill-free period). A total of 1030 subjects (NuvaRing, n=512; COC, n=518) was randomized and started treatment (intent-to-treat [ITT] population). The percentage of women in the ITT population who completed the trial was 70.9% for the NuvaRing group and 71.2% for the COC group. Five in-treatment pregnancies occurred in each group, giving Pearl indices of 1.23 for NuvaRing and 1.19 for the COC. Compliance with both treatments was excellent and both were well tolerated. In conclusion, NuvaRing has comparable efficacy and tolerability with a COC containing 150 μg of LNG and 30 μg of EE and does not require daily dosing.
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ovarian function with the contraceptive vaginal ring or an oral contraceptive a randomized study
Human Reproduction, 2004Co-Authors: Ingrid Duijkers, Carole H J Verhoeven, Christine Klipping, Thom O M DiebenAbstract:The effects on ovarian function of the combined contraceptive vaginal ring NuvaRing and a combined oral contraceptive (COC) were compared. This randomized open-label study was performed in 40 healthy female volunteers who were randomized by a computer-generated list after stratification for the ovulation day in a pretreatment cycle. They received two cycles of NuvaRing (21 subjects) or a COC (30mg ethinylestradiol and 150mg levonorgestrel 19 subjects). NuvaRing was started on cycle day 5 COC on cycle day 1. Follicular diameter endometrial thickness and FSH LH 17s-estradiol (E/2) and progesterone concentrations were determined. The median maximum follicular diameter (maxFD) was = 11mm during treatment. In the first treatment cycle the maxFD was lower in the COC than in the NuvaRing group due to the different starting procedures. MaxFD were not different in the second treatment cycle. In both groups E/2 and progesterone levels remained low during treatment. Ovulations did not occur. In both groups ovarian activity was adequately suppressed. Due to the different starting procedures lower ovarian activity was observed in the COC group in the first treatment cycle. In the second cycle ovarian suppression was comparable with NuvaRing and COC treatment. (authors)
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the contraceptive vaginal ring NuvaRing and hemostasis a comparative study
Contraception, 2004Co-Authors: E M Magnusdottir, Ragnheidur I Bjarnadottir, Pall T Onundarson, Brynja R Gudmundsdottir, Reynir Tomas Geirsson, S D Magnusdottir, Thom O M DiebenAbstract:This open-label, nonrandomized study compared changes in hemostatic variables during NuvaRing® and oral levonorgestrel 150 μg/ethinylestradiol 30 μg (LNG/EE) use for six cycles. Eighty-seven women started the study, 44 with NuvaRing and 43 with the LNG/EE oral contraceptive. For most procoagulation variables, there was no difference between NuvaRing and oral LNG/EE; only Factor VII levels increased in the NuvaRing group and decreased in the LNG/EE group. The majority of assessed variables show that anticoagulation and fibrinolytic activity was comparable between the NuvaRing and oral LNG/EE groups. Antithrombin activity and protein C activity both tended to be higher with NuvaRing. Levels of tissue plasminogen activator decreased in both groups but the reduction was smaller with NuvaRing. There were no significant differences in fibrin turnover between the treatment groups. The data show that both NuvaRing and oral LNG/EE are associated with a minimal effect on hemostatic variables.
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the combined contraceptive vaginal ring NuvaRing and lipid metabolism a comparative study
Contraception, 2004Co-Authors: Marjo Tuppurainen, R Klimscheffskij, M Venhola, Thom O M DiebenAbstract:Abstract This study compared the lipid profile after three and six cycles of treatment with NuvaRing® delivering 15 μg ethinylestradiol and 120 μg etonogestrel daily with a combined oral contraceptive (COC) containing ethinylestradiol 30 μg and levonorgestrel 150 μg. In the NuvaRing group 40 women were treated and 43 in the COC group. Compared with baseline, total cholesterol did not change in either group. NuvaRing did not affect HDL, but HDL, HDL2 and HDL3 levels decreased with the COC. In contrast, HDL2 increased with NuvaRing at cycle 3. LDL increased after cycles 3 and 6 with COC, and decreased after three cycles of NuvaRing treatment. Apolipoprotein A-1 levels increased with NuvaRing, but decreased with COC; apolipoprotein B and triglycerides increased, and lipoprotein(a) decreased in both groups. Sex hormone-binding globulin increased markedly more with NuvaRing, whereas corticosteroid-binding globulin levels increased less. These changes reflect the lower androgenicity of etonogestrel versus levonorgestrel and show that NuvaRing has a minimal effect on lipid profile.
Ragnheidur I Bjarnadottir - One of the best experts on this subject based on the ideXlab platform.
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the contraceptive vaginal ring NuvaRing and hemostasis a comparative study
Contraception, 2004Co-Authors: E M Magnusdottir, Ragnheidur I Bjarnadottir, Pall T Onundarson, Brynja R Gudmundsdottir, Reynir Tomas Geirsson, S D Magnusdottir, Thom O M DiebenAbstract:This open-label, nonrandomized study compared changes in hemostatic variables during NuvaRing® and oral levonorgestrel 150 μg/ethinylestradiol 30 μg (LNG/EE) use for six cycles. Eighty-seven women started the study, 44 with NuvaRing and 43 with the LNG/EE oral contraceptive. For most procoagulation variables, there was no difference between NuvaRing and oral LNG/EE; only Factor VII levels increased in the NuvaRing group and decreased in the LNG/EE group. The majority of assessed variables show that anticoagulation and fibrinolytic activity was comparable between the NuvaRing and oral LNG/EE groups. Antithrombin activity and protein C activity both tended to be higher with NuvaRing. Levels of tissue plasminogen activator decreased in both groups but the reduction was smaller with NuvaRing. There were no significant differences in fibrin turnover between the treatment groups. The data show that both NuvaRing and oral LNG/EE are associated with a minimal effect on hemostatic variables.
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comparison of cycle control with a combined contraceptive vaginal ring and oral levonorgestrel ethinyl estradiol
American Journal of Obstetrics and Gynecology, 2002Co-Authors: Ragnheidur I Bjarnadottir, Marjo Tuppurainen, S R KillickAbstract:Abstract OBJECTIVE: The purpose of this study was to compare cycle control and tolerability of the NuvaRing (NV Organon, Oss, The Netherlands), a novel combined contraceptive vaginal ring, with a standard combined oral contraceptive pill. STUDY DESIGN: Healthy women aged 18 to 40 years who requested contraception received either NuvaRing or a combined oral contraceptive containing 30 μg ethinyl estradiol and 150 μg levonorgestrel for 6 cycles in 3 similarly designed studies. Each cycle comprised 3 weeks of ring or pill use, followed by 1 ring- or pill-free week. RESULTS: Two hundred forty-seven women began the studies, 121 women with NuvaRing and 126 women with the combined oral contraceptive. Withdrawal bleeding occurred in virtually all cycles in both groups. In the NuvaRing groups, the incidence of irregular bleeding was ≤5% in all cycles; this was lower than the combined oral contraceptive groups (5.4%-38.8%). Furthermore, the incidence of a normal intended bleeding pattern was significantly higher in the NuvaRing groups than in the combined oral contraceptive groups ( P CONCLUSION: NuvaRing has excellent cycle control and is well tolerated. (Am J Obstet Gynecol 2002;186:389-95.)
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comparison of cycle control with a combined contraceptive vaginal ring and oral levonorgestrel ethinyl estradiol
American Journal of Obstetrics and Gynecology, 2002Co-Authors: Ragnheidur I Bjarnadottir, Marjo Tuppurainen, S R KillickAbstract:Abstract OBJECTIVE: The purpose of this study was to compare cycle control and tolerability of the NuvaRing (NV Organon, Oss, The Netherlands), a novel combined contraceptive vaginal ring, with a standard combined oral contraceptive pill. STUDY DESIGN: Healthy women aged 18 to 40 years who requested contraception received either NuvaRing or a combined oral contraceptive containing 30 μg ethinyl estradiol and 150 μg levonorgestrel for 6 cycles in 3 similarly designed studies. Each cycle comprised 3 weeks of ring or pill use, followed by 1 ring- or pill-free week. RESULTS: Two hundred forty-seven women began the studies, 121 women with NuvaRing and 126 women with the combined oral contraceptive. Withdrawal bleeding occurred in virtually all cycles in both groups. In the NuvaRing groups, the incidence of irregular bleeding was ≤5% in all cycles; this was lower than the combined oral contraceptive groups (5.4%-38.8%). Furthermore, the incidence of a normal intended bleeding pattern was significantly higher in the NuvaRing groups than in the combined oral contraceptive groups ( P CONCLUSION: NuvaRing has excellent cycle control and is well tolerated. (Am J Obstet Gynecol 2002;186:389-95.)
Carole H J Verhoeven - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of a contraceptive vaginal ring NuvaRing compared with a combined oral contraceptive a 1 year randomized trial
Contraception, 2005Co-Authors: Kristjan Oddsson, Carole H J Verhoeven, Beate Leifelsfischer, Nilson Roberto De Melo, Dominique Wielmasson, Chiara Benedetto, Thom O M DiebenAbstract:This open-label, randomized, Phase III study compared the efficacy and tolerability of and compliance with NuvaRing, a combined contraceptive vaginal ring releasing 15 μg of ethinylestradiol (EE) and 120 μg of etonogestrel daily, with those of and with a combined oral contraceptive (COC) containing 150 μg of levonorgestrel (LNG) and 30 μg of EE. Subjects received NuvaRing or a COC for 13 cycles (3 weeks of ring/pill treatment followed by a 1-week ring-/pill-free period). A total of 1030 subjects (NuvaRing, n=512; COC, n=518) was randomized and started treatment (intent-to-treat [ITT] population). The percentage of women in the ITT population who completed the trial was 70.9% for the NuvaRing group and 71.2% for the COC group. Five in-treatment pregnancies occurred in each group, giving Pearl indices of 1.23 for NuvaRing and 1.19 for the COC. Compliance with both treatments was excellent and both were well tolerated. In conclusion, NuvaRing has comparable efficacy and tolerability with a COC containing 150 μg of LNG and 30 μg of EE and does not require daily dosing.
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efficacy and safety of a contraceptive vaginal ring NuvaRing compared with a combined oral contraceptive a 1 year randomized trial
Contraception, 2005Co-Authors: Kristjan Oddsson, Carole H J Verhoeven, Beate Leifelsfischer, Nilson Roberto De Melo, Dominique Wielmasson, Chiara Benedetto, Thom O M DiebenAbstract:This open-label, randomized, Phase III study compared the efficacy and tolerability of and compliance with NuvaRing, a combined contraceptive vaginal ring releasing 15 μg of ethinylestradiol (EE) and 120 μg of etonogestrel daily, with those of and with a combined oral contraceptive (COC) containing 150 μg of levonorgestrel (LNG) and 30 μg of EE. Subjects received NuvaRing or a COC for 13 cycles (3 weeks of ring/pill treatment followed by a 1-week ring-/pill-free period). A total of 1030 subjects (NuvaRing, n=512; COC, n=518) was randomized and started treatment (intent-to-treat [ITT] population). The percentage of women in the ITT population who completed the trial was 70.9% for the NuvaRing group and 71.2% for the COC group. Five in-treatment pregnancies occurred in each group, giving Pearl indices of 1.23 for NuvaRing and 1.19 for the COC. Compliance with both treatments was excellent and both were well tolerated. In conclusion, NuvaRing has comparable efficacy and tolerability with a COC containing 150 μg of LNG and 30 μg of EE and does not require daily dosing.
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ovarian function with the contraceptive vaginal ring or an oral contraceptive a randomized study
Human Reproduction, 2004Co-Authors: Ingrid Duijkers, Carole H J Verhoeven, Christine Klipping, Thom O M DiebenAbstract:The effects on ovarian function of the combined contraceptive vaginal ring NuvaRing and a combined oral contraceptive (COC) were compared. This randomized open-label study was performed in 40 healthy female volunteers who were randomized by a computer-generated list after stratification for the ovulation day in a pretreatment cycle. They received two cycles of NuvaRing (21 subjects) or a COC (30mg ethinylestradiol and 150mg levonorgestrel 19 subjects). NuvaRing was started on cycle day 5 COC on cycle day 1. Follicular diameter endometrial thickness and FSH LH 17s-estradiol (E/2) and progesterone concentrations were determined. The median maximum follicular diameter (maxFD) was = 11mm during treatment. In the first treatment cycle the maxFD was lower in the COC than in the NuvaRing group due to the different starting procedures. MaxFD were not different in the second treatment cycle. In both groups E/2 and progesterone levels remained low during treatment. Ovulations did not occur. In both groups ovarian activity was adequately suppressed. Due to the different starting procedures lower ovarian activity was observed in the COC group in the first treatment cycle. In the second cycle ovarian suppression was comparable with NuvaRing and COC treatment. (authors)
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the combined contraceptive vaginal ring NuvaRing and tampon co usage
Contraception, 2004Co-Authors: Carole H J Verhoeven, Thom O M DiebenAbstract:We investigated the effect of tampon co-usage on systemic exposure to etonogestrel (ENG) and ethinylestradiol (EE) from the combined contraceptive vaginal ring, NuvaRing®. One cycle of ring use consists of 3 weeks of ring use followed by a 1-week ring-free period. Fourteen healthy women were randomized to use both NuvaRing and tampons (Kotex® regular) or NuvaRing alone for one cycle; participants then switched to the alternate treatment regimen for a second cycle of ring use. The first tampon was self-administered on day 8 of the interaction cycle; 4 tampons a day were used for 3 consecutive days. Tampon co-usage did not result in any changes in serum ENG or EE concentrations and is thus not expected to compromise the ring's contraceptive efficacy.
S R Killick - One of the best experts on this subject based on the ideXlab platform.
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comparison of cycle control with a combined contraceptive vaginal ring and oral levonorgestrel ethinyl estradiol
American Journal of Obstetrics and Gynecology, 2002Co-Authors: Ragnheidur I Bjarnadottir, Marjo Tuppurainen, S R KillickAbstract:Abstract OBJECTIVE: The purpose of this study was to compare cycle control and tolerability of the NuvaRing (NV Organon, Oss, The Netherlands), a novel combined contraceptive vaginal ring, with a standard combined oral contraceptive pill. STUDY DESIGN: Healthy women aged 18 to 40 years who requested contraception received either NuvaRing or a combined oral contraceptive containing 30 μg ethinyl estradiol and 150 μg levonorgestrel for 6 cycles in 3 similarly designed studies. Each cycle comprised 3 weeks of ring or pill use, followed by 1 ring- or pill-free week. RESULTS: Two hundred forty-seven women began the studies, 121 women with NuvaRing and 126 women with the combined oral contraceptive. Withdrawal bleeding occurred in virtually all cycles in both groups. In the NuvaRing groups, the incidence of irregular bleeding was ≤5% in all cycles; this was lower than the combined oral contraceptive groups (5.4%-38.8%). Furthermore, the incidence of a normal intended bleeding pattern was significantly higher in the NuvaRing groups than in the combined oral contraceptive groups ( P CONCLUSION: NuvaRing has excellent cycle control and is well tolerated. (Am J Obstet Gynecol 2002;186:389-95.)
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comparison of cycle control with a combined contraceptive vaginal ring and oral levonorgestrel ethinyl estradiol
American Journal of Obstetrics and Gynecology, 2002Co-Authors: Ragnheidur I Bjarnadottir, Marjo Tuppurainen, S R KillickAbstract:Abstract OBJECTIVE: The purpose of this study was to compare cycle control and tolerability of the NuvaRing (NV Organon, Oss, The Netherlands), a novel combined contraceptive vaginal ring, with a standard combined oral contraceptive pill. STUDY DESIGN: Healthy women aged 18 to 40 years who requested contraception received either NuvaRing or a combined oral contraceptive containing 30 μg ethinyl estradiol and 150 μg levonorgestrel for 6 cycles in 3 similarly designed studies. Each cycle comprised 3 weeks of ring or pill use, followed by 1 ring- or pill-free week. RESULTS: Two hundred forty-seven women began the studies, 121 women with NuvaRing and 126 women with the combined oral contraceptive. Withdrawal bleeding occurred in virtually all cycles in both groups. In the NuvaRing groups, the incidence of irregular bleeding was ≤5% in all cycles; this was lower than the combined oral contraceptive groups (5.4%-38.8%). Furthermore, the incidence of a normal intended bleeding pattern was significantly higher in the NuvaRing groups than in the combined oral contraceptive groups ( P CONCLUSION: NuvaRing has excellent cycle control and is well tolerated. (Am J Obstet Gynecol 2002;186:389-95.)
Mohamed Fayez Bazeed - One of the best experts on this subject based on the ideXlab platform.
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contraceptive vaginal ring treatment of heavy menstrual bleeding a randomized controlled trial with norethisterone
Contraception, 2012Co-Authors: Hatem Abu Hashim, Waleed Alsherbini, Mohamed Fayez BazeedAbstract:BACKGROUND: This study compared the efficacy of the contraceptive vaginal ring (CVR; NuvaRing; N.V. Organon, Oss, the Netherlands) and norethisterone for treatment of idiopathic heavy menstrual bleeding (HMB) during the fertile age. STUDY DESIGN: Ninety-five women with idiopathic HMB were selected in this randomized controlled trial. They were treated with either the CVR (n=48) or norethisterone (n=47) for three cycles. Each cycle consisted of 3 weeks of CVR use and then a 1-week ring-free period or norethisterone tablets, 5 mg three times daily from Cycle Days 5 to 26. Outcome measures were as follows: menstrual blood loss assessed by pictorial blood loss assessment chart (PBAC), duration of menses, hemoglobin, serum ferritin, quality of life (QoL) questionnaire, side effects and overall satisfaction with treatment. RESULT: Significant improvements in PBAC score, the duration of menses, hemoglobin, serum ferritin and QoL were observed at the end of the study in each group. No statistically significant differences were found regarding the mean PBAC score (90.2±24.4 vs. 92.3±26.7) and its percent reduction (68.6% vs. 69.5%), duration of menses (5.3±1.2 vs. 5.5±1.1 days), hemoglobin and serum ferritin at the end of the study between the CVR and the norethisterone groups, respectively. Significantly more ring users were satisfied and elected to continue with treatment. CONCLUSION: Both the CVR and oral norethisterone are effective treatments for idiopathic HMB. The CVR may be an attractive option especially for those requesting contraception as well.
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contraceptive vaginal ring treatment of heavy menstrual bleeding a randomized controlled trial with norethisterone
Contraception, 2012Co-Authors: Hatem Abu Hashim, Waleed Alsherbini, Mohamed Fayez BazeedAbstract:BACKGROUND: This study compared the efficacy of the contraceptive vaginal ring (CVR; NuvaRing; N.V. Organon Oss the Netherlands) and norethisterone for treatment of idiopathic heavy menstrual bleeding (HMB) during the fertile age. STUDY DESIGN: Ninety-five women with idiopathic HMB were selected in this randomized controlled trial. They were treated with either the CVR (n=48) or norethisterone (n=47) for three cycles. Each cycle consisted of 3 weeks of CVR use and then a 1-week ring-free period or norethisterone tablets 5 mg three times daily from Cycle Days 5 to 26. Outcome measures were as follows: menstrual blood loss assessed by pictorial blood loss assessment chart (PBAC) duration of menses hemoglobin serum ferritin quality of life (QoL) questionnaire side effects and overall satisfaction with treatment. RESULT: Significant improvements in PBAC score the duration of menses hemoglobin serum ferritin and QoL were observed at the end of the study in each group. No statistically significant differences were found regarding the mean PBAC score (90.2+/-24.4 vs. 92.3+/-26.7) and its percent reduction (68.6% vs. 69.5%) duration of menses (5.3+/-1.2 vs. 5.5+/-1.1 days) hemoglobin and serum ferritin at the end of the study between the CVR and the norethisterone groups respectively. Significantly more ring users were satisfied and elected to continue with treatment. CONCLUSION: Both the CVR and oral norethisterone are effective treatments for idiopathic HMB. The CVR may be an attractive option especially for those requesting contraception as well. Copyright (c) 2012 Elsevier Inc. All rights reserved.