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

May 8, 2014 updated by: Duramed Research

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Temple, Texas, United States, 76508
        • Duramed Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Seasonique (LNG/EE and EE)
1 tablet daily
Active Comparator: 2
Drug: Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]
1 tablet daily
Active Comparator: 3
Drug: Portia (LNG/EE)
1 tablet daily x 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Before, during and after the 7-day hormone free interval or EE-supplemented interval

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duramed Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

June 30, 2005

First Posted (Estimate)

July 6, 2005

Study Record Updates

Last Update Posted (Estimate)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR PSE 310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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