A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens
Completed
Duramed Research
Phase 3
2005-06-01
This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy,
reproductive-aged women using three different regimens of oral contraceptives (OCs). Two
extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days
followed by 7 days of placebo), and Seasonique (levonorgestrel/ethinyl estradiol 0.15/0.03 mg
for 84 days followed by 7 days of ethinyl estradiol 0.01 mg), and a 28-day regimen OC, Portia
(levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 21 days followed by 7 days of placebo).
A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
Completed
Duramed Research
Phase 3
2005-01-01
This study is being conducted to evaluate the effects of treatment with Seasonique an
extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the
typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study
duration will be approximately 9 months. Patients will be required to record menstrual pain
in a daily diary.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phase 4
2009-09-01
The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral
contraceptive metabolism in a manner which results in decreased effectiveness in obese women.
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