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 2
2005-05-01
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 13 weeks of treatment with the option to
extend blinded therapy for an additional 13 weeks. The overall study duration will be 6-9
months. Patients will be required to record menstrual pain in a daily diary.
A Multicenter Study to Evaluate the Safety of Seasonique, an Oral Contraceptive.
Completed
Duramed Research
Phase 3
2003-05-01
This study is being conducted to evaluate the safety of ethinyl an extended-regimen oral
contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for
up to an additional three consecutive years.
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