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

Tracking Information

First Received Date ^ICMJE

June 30, 2005

Last Updated Date

July 23, 2009

Start Date ^ICMJE

June 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Compare differences in hormone patterns (follicle stimulating hormone [FSH], luteinizing hormone [LH], inhibin-B, and estradiol)

Change History

Complete list of historical versions of study NCT00117273 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Compare the differences in hormone withdrawal symptoms [ Time Frame: Before, during and after the 7-day hormone free interval or EE-supplemented interval ] [ Designated as 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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Compare the differences in hormone withdrawal symptoms
Compare differences in ovarian follicular development before, during and after the 7-day hormone free interval or ethinyl estradiol-supplemented intervals.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]
Drug: Seasonique (LNG/EE and EE)
Drug: Portia (LNG/EE)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00117273

Responsible Party

Duramed Protocol Chair, Duramed Research, Inc.

Study ID Numbers ^ICMJE

DR PSE 310

Study Sponsor ^ICMJE

Duramed Research

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Duramed Protocol Chair

Duramed Research, Inc.

Information Provided By

Duramed Research

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP