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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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 symptoms

Compare 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
Last updated: May 8, 2014

Page last updated: August 23, 2015

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