A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens
Information source: Duramed Research
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)] (Drug); Seasonique (LNG/EE and EE) (Drug); Portia (LNG/EE) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Duramed Research Official(s) and/or principal investigator(s):
Duramed Protocol Chair, Study Chair, Affiliation: Duramed Research, Inc.
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).
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacodynamics Study
Primary outcome: Compare differences in hormone patterns (follicle stimulating hormone [FSH], luteinizing hormone [LH], inhibin-B, and estradiol)
Secondary outcome: Compare the differences in hormone withdrawal symptomsCompare differences in ovarian follicular development
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
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
Locations and Contacts
Duramed Investigational Site, Temple, Texas 76508, United States
Additional Information
Mayo Clinic - Birth Control Guide
Starting date: June 2005
Ending date: June 2006
Last updated: February 29, 2008
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