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A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens

NCT00117273 ↗

Phase 3 Completed 36 enrolled Duramed Research
RandomizedParallel-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2005-06
Primary completion
—
Completion
2006-06

Drugs

EvaluationDrugModalityDoseRoute
Subject 91-day Levonorgestrel Oral Contraceptive Unknown 0.03 mg Oral
Subject 91-day Levonorgestrel Oral Contraceptive Unknown 0.15 mg Oral
Comparator Portia Unknown 0.03 mg Oral
Comparator Portia Unknown 0.15 mg Oral
Comparator Seasonale Unknown 0.03 mg Oral
Comparator Seasonale Unknown 0.15 mg Oral

Indications

No indication recorded.