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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR NORPLANT SYSTEM IN PLASTIC CONTAINER

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Clinical Trials for Norplant System In Plastic Container

Trial ID Title Status Sponsor Phase Summary
NCT00064766 Norplant and Irregular Bleeding/Spotting Unknown status Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 4 Irregular or prolonged menstrual bleeding and/or spotting are common side effects in patients using progestin-only hormonal contraception such as levonorgestrel implants (Norplant). Doxycycline, a drug approved by the Food and Drug Administration (FDA) to treat gum disease, may reduce the occurrence of uterine bleeding and spotting in women who use Norplant. This study will evaluate the effects of doxycycline on uterine bleeding/spotting in women using Norplant.
NCT00563576 Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation Completed Columbia University N/A Many women choose Depo-Provera for birth control because it is easy to use and very effective. However, a significant number of Depo-Provera users experience irregular bleeding during the first 90 days. Many users discontinue after their first injection due to irregular bleeding. This study will evaluate the effect of using an estrogen vaginal ring during the first 90 days of Depo-Provera use to see if it is acceptable to women and whether it decreases irregular bleeding during the first 90 days of use and increases continuation to a second injection.
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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Norplant System In Plastic Container

Condition Name

Condition Name for Norplant System In Plastic Container
Intervention Trials
Contraception 1
Pharmacokinetics 1
Bleeding 1
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Condition MeSH

Condition MeSH for Norplant System In Plastic Container
Intervention Trials
Hemorrhage 3
Metrorrhagia 1
Periodontal Diseases 1
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Clinical Trial Locations for Norplant System In Plastic Container

Trials by Country

Trials by Country for Norplant System In Plastic Container
Location Trials
United States 6
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Trials by US State

Trials by US State for Norplant System In Plastic Container
Location Trials
New York 2
Rhode Island 1
Oregon 1
Missouri 1
Virginia 1
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Clinical Trial Progress for Norplant System In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Norplant System In Plastic Container
Clinical Trial Phase Trials
Phase 4 2
N/A 4
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Clinical Trial Status

Clinical Trial Status for Norplant System In Plastic Container
Clinical Trial Phase Trials
Completed 4
Recruiting 1
Unknown status 1
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Clinical Trial Sponsors for Norplant System In Plastic Container

Sponsor Name

Sponsor Name for Norplant System In Plastic Container
Sponsor Trials
Columbia University 2
American College of Obstetricians and Gynecologists 1
Organon 1
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Sponsor Type

Sponsor Type for Norplant System In Plastic Container
Sponsor Trials
Other 7
NIH 1
Industry 1
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Argus Health
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