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

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Duramed Research
• Treatments: Contraceptive Agents; Contraceptives, Oral; Estradiol; Ethinyl Estradiol; Levonorgestrel

Criteria

Inclusion Criteria:

• Premenopausal

• Not pregnant or breastfeeding

• Weight <200 lbs

• Currently taking oral contraceptives in the standard 28-day regimen for at least two months

Exclusion Criteria:

• Any contraindication to the use of oral contraceptives

• Pregnancy within the last 3 months

• Smoking > 10 cigarettes per day