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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR ETHINYL ESTRADIOL; ETONOGESTREL

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Clinical Trials for Ethinyl Estradiol; Etonogestrel

Trial ID Title Status Sponsor Phase Summary
NCT00369967 Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents Terminated American College of Obstetricians and Gynecologists N/A We hypothesize that using "quick start" initiation of the contraceptive vaginal ring in adolescents seeking birth control will improve compliance compared to traditional start. We will conduct a randomized controlled trial comparing "quick start" to traditional start initiation of the contraceptive vaginal ring in adolescents seeking birth control. The primary study outcome is method continuation at 3, 6, and 12 months. Secondary outcomes include abnormal bleeding, product satisfaction, and adverse events.
NCT00369967 Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents Terminated Bayer N/A We hypothesize that using "quick start" initiation of the contraceptive vaginal ring in adolescents seeking birth control will improve compliance compared to traditional start. We will conduct a randomized controlled trial comparing "quick start" to traditional start initiation of the contraceptive vaginal ring in adolescents seeking birth control. The primary study outcome is method continuation at 3, 6, and 12 months. Secondary outcomes include abnormal bleeding, product satisfaction, and adverse events.
NCT00369967 Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents Terminated Virginia Commonwealth University N/A We hypothesize that using "quick start" initiation of the contraceptive vaginal ring in adolescents seeking birth control will improve compliance compared to traditional start. We will conduct a randomized controlled trial comparing "quick start" to traditional start initiation of the contraceptive vaginal ring in adolescents seeking birth control. The primary study outcome is method continuation at 3, 6, and 12 months. Secondary outcomes include abnormal bleeding, product satisfaction, and adverse events.
NCT00612508 Hormonal Contraception and Vaginal Health Completed Oregon Clinical and Translational Research Institute N/A The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).
NCT00612508 Hormonal Contraception and Vaginal Health Completed Oregon Health and Science University N/A The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).
NCT00710606 Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing® Completed Organon N/A There are over 60 million women of reproductive age in the U.S. and a majority of these women qualify as overweight or obese. Evidence suggests that there is an association between increased body weight and decreased contraceptive efficacy. Studies with the combined hormonal contraceptive patch (Evra®) and the subdermal contraceptive implant (Norplant®) demonstrate higher failure rates in heavier versus lighter women. Weight related differences in the effectiveness of NuvaRing® need further study. A single secondary analysis of pooled data from Phase III clinical trials of NuvaRing® noted no difference in pregnancy rates among women in the highest weight decile (>166#) versus the rest of the study population using the ring. (Westhoff, 2005) The finding of no difference, however, was influenced by too few obese subjects in the analysis which contributed to wide confidence limits. Additional studies are needed to explore how well the contraceptive ring functions to maintain effective serum steroid concentrations to suppress ovarian activity in obese women. This investigation focused on evaluating mean serum concentrations of hormones released in obese and normal weight women using the NuvaRing® . This study was a prospective clinical trial. Normal weight women are defined as women with a BMI 19-24.9 and obese women are those with a BMI 30-39.9. We recruited forty adult women interested in initiating the combined hormonal contraceptive ring to two months of use to complete analysis of at least 34 subjects (17 normal weight, 17 obese). We compared mean serum concentrations of ethinyl estradiol (E2) and etonogestrel (ENG) along with additional markers for ovarian suppression. These markers included sonographic evidence of follicular development and ovulation as well as circulating E2 levels which strongly correlate with follicular development and endometrial proliferation during the second month of NuvaRing® use. Assessment of these parameters will translated to understanding contraceptive-mediated suppression of ovarian function in these two groups. Subjects also logged patterns of ring use and bleeding patterns during the study period.
NCT00710606 Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing® Completed Columbia University N/A There are over 60 million women of reproductive age in the U.S. and a majority of these women qualify as overweight or obese. Evidence suggests that there is an association between increased body weight and decreased contraceptive efficacy. Studies with the combined hormonal contraceptive patch (Evra®) and the subdermal contraceptive implant (Norplant®) demonstrate higher failure rates in heavier versus lighter women. Weight related differences in the effectiveness of NuvaRing® need further study. A single secondary analysis of pooled data from Phase III clinical trials of NuvaRing® noted no difference in pregnancy rates among women in the highest weight decile (>166#) versus the rest of the study population using the ring. (Westhoff, 2005) The finding of no difference, however, was influenced by too few obese subjects in the analysis which contributed to wide confidence limits. Additional studies are needed to explore how well the contraceptive ring functions to maintain effective serum steroid concentrations to suppress ovarian activity in obese women. This investigation focused on evaluating mean serum concentrations of hormones released in obese and normal weight women using the NuvaRing® . This study was a prospective clinical trial. Normal weight women are defined as women with a BMI 19-24.9 and obese women are those with a BMI 30-39.9. We recruited forty adult women interested in initiating the combined hormonal contraceptive ring to two months of use to complete analysis of at least 34 subjects (17 normal weight, 17 obese). We compared mean serum concentrations of ethinyl estradiol (E2) and etonogestrel (ENG) along with additional markers for ovarian suppression. These markers included sonographic evidence of follicular development and ovulation as well as circulating E2 levels which strongly correlate with follicular development and endometrial proliferation during the second month of NuvaRing® use. Assessment of these parameters will translated to understanding contraceptive-mediated suppression of ovarian function in these two groups. Subjects also logged patterns of ring use and bleeding patterns during the study period.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ethinyl Estradiol; Etonogestrel

Condition Name

Condition Name for Ethinyl Estradiol; Etonogestrel
Intervention Trials
Vaginal Epithelial Disruption 1
Underweight 1
Pharmacokinetics 1
Contraceptive Usage 1
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Condition MeSH

Condition MeSH for Ethinyl Estradiol; Etonogestrel
Intervention Trials
Vaginosis, Bacterial 1
Vaginal Diseases 1
Thinness 1
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Clinical Trial Locations for Ethinyl Estradiol; Etonogestrel

Trials by Country

Trials by Country for Ethinyl Estradiol; Etonogestrel
Location Trials
United States 4
Brazil 1
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Trials by US State

Trials by US State for Ethinyl Estradiol; Etonogestrel
Location Trials
Virginia 2
New York 1
Oregon 1
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Clinical Trial Progress for Ethinyl Estradiol; Etonogestrel

Clinical Trial Phase

Clinical Trial Phase for Ethinyl Estradiol; Etonogestrel
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
N/A 3
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Clinical Trial Status

Clinical Trial Status for Ethinyl Estradiol; Etonogestrel
Clinical Trial Phase Trials
Completed 3
Terminated 2
Unknown status 1
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Clinical Trial Sponsors for Ethinyl Estradiol; Etonogestrel

Sponsor Name

Sponsor Name for Ethinyl Estradiol; Etonogestrel
Sponsor Trials
Merck Sharp & Dohme Corp. 2
Virginia Commonwealth University 1
University of Campinas, Brazil 1
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Sponsor Type

Sponsor Type for Ethinyl Estradiol; Etonogestrel
Sponsor Trials
Other 8
Industry 4
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