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

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacodynamics Study

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2
• Active Comparator: 3

Primary Measures

• Compare differences in hormone patterns (follicle stimulating hormone [FSH], luteinizing hormone [LH], inhibin-B, and estradiol)
  • Time Frame: Before, during and after the 7-day hormone free interval or EE-supplemented interval
    Safety Issue?: No

Secondary Measures

• Compare the differences in hormone withdrawal symptoms
  • Time Frame: Before, during and after the 7-day hormone free interval or EE-supplemented interval
    Safety Issue?: No
• Compare differences in ovarian follicular development
  • Time Frame: Before, during and after the 7-day hormone free interval or EE-supplemented intervals
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Duramed Research

Overall Clinical Trial Officials and Contacts

Duramed Protocol Chair Study Chair Duramed Research, Inc.  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00117273

Study ID Number: DR PSE 310

ClinicalTrials.gov Identifier: NCT00117273

Health Authority: United States: Food and Drug Administration

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