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

Completed · Phase 3

Conditions studied: Healthy

In brief

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).

Key facts

Study ID

NCT00117273

Run by

Duramed Research

People needed

36

Starts

2005-06-01

Expected to finish

2006-06-01

Last updated by the study team

2014-05-09

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Premenopausal
• Not pregnant or breastfeeding
• Weight <200 lbs
• Currently taking oral contraceptives in the standard 28-day regimen for at least two months

You may not qualify if…

• Any contraindication to the use of oral contraceptives
• Pregnancy within the last 3 months
• Smoking > 10 cigarettes per day

Where it is running

• Duramed Investigational Site — Temple, Texas, United States

Full record on ClinicalTrials.gov

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