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

Phase 3

Completed

• Conditions: Healthy
• Interventions: Drug: Portia (LNG/EE); Drug: Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]; Drug: Seasonique (LNG/EE and EE)

• Registration Number: NCT00117273
• Lead Sponsor: Duramed Research

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-06
• Study Completion: 2006-06
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-08
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Portia (LNG/EE)	-
2	Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]	-
1	Seasonique (LNG/EE and EE)	-

Primary Outcome Measures

Name	Time	Method
Compare differences in hormone patterns (follicle stimulating hormone [FSH], luteinizing hormone [LH], inhibin-B, and estradiol)	Before, during and after the 7-day hormone free interval or EE-supplemented interval

Secondary Outcome Measures

Name	Time	Method
Compare the differences in hormone withdrawal symptoms	Before, during and after the 7-day hormone free interval or EE-supplemented interval
Compare differences in ovarian follicular development	Before, during and after the 7-day hormone free interval or EE-supplemented intervals

Trial Locations

Locations (1)

Duramed Investigational Site; 🇺🇸 Temple, Texas, United States