NCT00117273

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

A Prospective, Single-Center, Open-Label, Randomized Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Regimens of Oral Contraceptive Pills

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Duramed Research · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]	1 tablet daily
DRUG	Seasonique (LNG/EE and EE)	1 tablet daily
DRUG	Portia (LNG/EE)	1 tablet daily x 28 days

Timeline

• Start date: 2005-06-01
• Completion: 2006-06-01
• First posted: 2005-07-06
• Last updated: 2014-05-09

Locations

1 site across 1 country: United States