Study of Bleeding With Extended Administration of an Oral Contraceptive

May 7, 2008 updated by: Warner Chilcott

Open-Label Study of Cycle Control With Extended Administration of Norethindrone Acetate 1 mg / Ethinyl Estradiol 20 Mcg Oral Tablets

This is an non-comparative study. There is no statistical hypothesis. The effects of extension of treatment on bleeding will be recorded and described.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 2

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
    • Arizona
      • Phoenix, Arizona, United States, 85031
        • Warner Chilcott Investigational Site
      • Phoenix, Arizona, United States, 85050
        • Warner Chilcott Investigational Site
      • Tempe, Arizona, United States, 85283
        • Warner Chilcott Investigational Site
    • California
      • Carmichael, California, United States, 95608
        • Warner Chilcott Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Warner Chilcott Investigational Site
      • Leesburg, Florida, United States, 34748
        • Warner Chilcott Investigational Site
      • Miami, Florida, United States, 33143
        • Warner Chilcott Investigational Site
      • Miami, Florida, United States, 33186
        • Warner Chilcott Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • Warner Chilcott Investigational Site
    • Georgia
      • Decatur, Georgia, United States, 30034
        • Warner Chilcott Investigational Site
      • Roswell, Georgia, United States, 30075
        • Warner Chilcott Investigational Site
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Warner Chilcott Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Warner Chilcott Investigational Site
      • Louisville, Kentucky, United States, 40291
        • Warner Chilcott Investigational Site
    • North Carolina
      • New Bern, North Carolina, United States, 28562
        • Warner Chilcott Investigational Site
      • Winston Salem, North Carolina, United States, 27103
        • Warner Chilcott Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Warner Chilcott Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Warner Chilcott Investigational Site
    • Utah
      • Pleasant Grove, Utah, United States, 84062
        • Warner Chilcott Investigational Site
      • Salt Lake City, Utah, United States, 84017
        • Warner Chilcott Investigational Site
      • Sandy, Utah, United States, 84070
        • Warner Chilcott Investigational Site
    • Virginia
      • Virginia Beach, Virginia, United States, 23456
        • Warner Chilcott Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Warner Chilcott 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

25 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy women
  • Age 25-40
  • History of regular cycles

Exclusion Criteria:

  • Current or recent (within 2 months) users of hormonal contraceptives
  • Contraindications for use of hormonal contraception
  • Conditions which affect the absorption or metabolism of steroid hormones
  • BMI > 35

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number of bleeding/spotting days/episodes per treatment cycle

Secondary Outcome Measures

Outcome Measure
Satisfaction

Collaborators and Investigators

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

Sponsor

Warner Chilcott

Investigators

  • Study Director: Herman Ellman, MD, Sponsor GmbH

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, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

June 16, 2006

First Submitted That Met QC Criteria

June 16, 2006

First Posted (Estimate)

June 20, 2006

Study Record Updates

Last Update Posted (Estimate)

May 8, 2008

Last Update Submitted That Met QC Criteria

May 7, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-02306

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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