Study of Safety and Efficacy of an Oral Contraceptive

April 15, 2013 updated by: Warner Chilcott

Open Label, Randomized, Comparator-Controlled Study of the Contraceptive Efficacy of Norethindrone Acetate (NA) and Ethinyl Estradiol (EE)

This is a comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding of norethindrone acetate/ethinyl estradiol (NETA/EE) administered for 24 days and NETA/EE administered for 21 days; and to assess the safety and tolerability of the product.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

938

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
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Warner Chilcott Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85031
        • Warner Chilcott Investigational Site
      • Phoenix, Arizona, United States, 85014
        • Warner Chilcott Investigational Site
    • California
      • Chico, California, United States, 95929
        • Warner Chilcott Investigational Site
      • Los Angeles, California, United States, 90033
        • Warner Chilcott Investigational Site
      • San Diego, California, United States, 92108
        • Warner Chilcott Investigational Site
      • San Diego, California, United States, 92103
        • Warner Chilcott Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80202
        • Warner Chilcott Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Warner Chilcott Investigational Site
      • Jacksonville, Florida, United States, 32207
        • Warner Chilcott Investigational Site
      • Miami, Florida, United States, 33186
        • Warner Chilcott Investigational Site
      • Palm Harbor, Florida, United States, 34684
        • Warner Chilcott Investigational Site
      • Venice, Florida, United States, 34285
        • Warner Chilcott Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • Warner Chilcott Investigational Site
    • Georgia
      • Decatur, Georgia, United States, 30034
        • Warner Chilcott Investigational Site
      • Decatur, Georgia, United States, 30033
        • Warner Chilcott Investigational Site
      • Powder Springs, Georgia, United States, 30127
        • Warner Chilcott Investigational Site
      • Roswell, Georgia, United States, 30075
        • Warner Chilcott Investigational Site
      • Savannah, Georgia, United States, 31405
        • Warner Chilcott Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Warner Chilcott Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64112
        • Warner Chilcott Investigational Site
      • St. Louis, Missouri, United States, 63117
        • 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
      • Allentown, Pennsylvania, United States, 18104
        • Warner Chilcott Investigational Site
      • Philadelphia, Pennsylvania, United States, 19114
        • Warner Chilcott Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15206
        • Warner Chilcott Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Warner Chilcott Investigational Site
      • Greenville, South Carolina, United States, 29605
        • Warner Chilcott Investigational Site
    • Utah
      • Sandy, Utah, United States, 84070
        • Warner Chilcott Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Warner Chilcott Investigational Site
      • Richmond, Virginia, United States, 23233
        • Warner Chilcott Investigational Site
      • 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

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy Women
  • Age 18-45
  • At risk for pregnancy
  • History of regular cycles

Exclusion Criteria:

  • 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 24 Day NA/EE
Norethindrone acetate 1 mg /ethinyl estradiol 20 mcg for 24 days of each 28 day cycle
Drug: Norethindrone Acetate/Ethinyl Estradiol 24 Days
One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets
Active Comparator: 21 Day NA/EE
Norethindrone acetate 1 mg/ethinyl estradiol 20 mcg for 21 days of each 28 day cycle
Drug: Norethindrone Acetate /Ethinyl Estradiol 21 Days
One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets
Other Names:
  • 21 Day NA/EE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population
Time Frame: 5.6 months (6 - 28 day cycles)
Pearl Index = 1300 * number of pregnancies/number of women-cycles of treatment
5.6 months (6 - 28 day cycles)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population
Time Frame: 5.6 months (6 - 28 day cycles)
Self-reported via patient completed diary (none - no vaginal bleeding, light - less than normal menstruation, normal - like normal menstruation, heavy - more than normal menstruation) along with daily use of sanitary protection (other than panty liners). Light bleeding requiring no more than single pad or tampon will be spotting.
5.6 months (6 - 28 day cycles)

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

January 1, 2004

Primary Completion (Actual)

November 1, 2004

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

June 30, 2009

First Submitted That Met QC Criteria

July 1, 2009

First Posted (Estimate)

July 3, 2009

Study Record Updates

Last Update Posted (Estimate)

April 22, 2013

Last Update Submitted That Met QC Criteria

April 15, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-03903

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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