Study of Safety and Efficacy of an Oral Contraceptive

April 15, 2013 updated by: Warner Chilcott

An Open Label Study of the Contraceptive Efficacy of Norethindrone and Ethinyl Estradiol.

This is a non-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; and to assess the safety and tolerability of the product.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1700

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
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Warner Chilcott Investigational Site
      • Phoenix, Arizona, United States, 85050
        • Warner Chilcott Investigational Site
      • Phoenix, Arizona, United States, 85032
        • Warner Chilcott Investigational Site
      • Phoenix, Arizona, United States, 85037
        • Warner Chilcott Investigational Site
      • Tempe, Arizona, United States, 85282
        • Warner Chilcott Investigational Site
      • Tucson, Arizona, United States, 85712
        • Warner Chilcott Investigational Site
    • California
      • San Diego, California, United States, 92108
        • Warner Chilcott Investigational Site
      • San Diego, California, United States, 92103
        • Warner Chilcott Investigational Site
      • Vista, California, United States, 92083
        • Warner Chilcott Investigational Site
    • Colorado
      • Castle Rock, Colorado, United States, 80108
        • Warner Chilcott Investigational Site
      • Denver, Colorado, United States, 80218
        • Warner Chilcott Investigational Site
      • Lakewood, Colorado, United States, 80228
        • Warner Chilcott Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Warner Chilcott Investigational Site
      • Brooksville, Florida, United States, 34613
        • Warner Chilcott Investigational Site
      • Clearwater, Florida, United States, 33759
        • Warner Chilcott Investigational Site
      • Gainesville, Florida, United States, 32607
        • Warner Chilcott Investigational Site
      • Jacksonville, Florida, United States, 32207
        • 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
      • Pembroke Pines, Florida, United States, 33021
        • Warner Chilcott Investigational Site
      • St. Petersburg, Florida, United States, 33709
        • Warner Chilcott Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • 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
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Warner Chilcott Investigational Site
      • Peoria, Illinois, United States, 61615
        • Warner Chilcott Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Warner Chilcott Investigational Site
    • Kansas
      • Arkansas City, Kansas, United States, 67005
        • Warner Chilcott Investigational Site
      • Wichita, Kansas, United States, 67207
        • Warner Chilcott Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Warner Chilcott Investigational Site
      • Louisville, Kentucky, United States, 40291
        • Warner Chilcott Investigational Site
    • Louisiana
      • Amite, Louisiana, United States, 70422
        • Warner Chilcott Investigational Site
      • Marrero, Louisiana, United States, 70072
        • Warner Chilcott Investigational Site
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • Warner Chilcott Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Warner Chilcott Investigational Site
      • Edison, New Jersey, United States, 08817
        • Warner Chilcott Investigational Site
      • Lawrenceville, New Jersey, United States, 08648
        • Warner Chilcott Investigational Site
      • Moorestown, New Jersey, United States, 08051
        • Warner Chilcott Investigational Site
    • New York
      • New York, New York, United States, 10016
        • Warner Chilcott Investigational Site
    • North Carolina
      • Cary, North Carolina, United States, 27511
        • Warner Chilcott Investigational Site
      • New Bern, North Carolina, United States, 28562
        • Warner Chilcott Investigational Site
      • Raleigh, North Carolina, United States, 27612
        • Warner Chilcott Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Warner Chilcott Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Warner Chilcott Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Warner Chilcott Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Warner Chilcott Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Warner Chilcott Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15206
        • Warner Chilcott Investigational Site
      • Pottstown, Pennsylvania, United States, 19464-3224
        • Warner Chilcott Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Warner Chilcott Investigational Site
    • Texas
      • Austin, Texas, United States, 78759
        • Warner Chilcott Investigational Site
      • Austin, Texas, United States, 78748
        • Warner Chilcott Investigational Site
      • Dallas, Texas, United States, 75234
        • Warner Chilcott Investigational Site
      • Houston, Texas, United States, 77030
        • Warner Chilcott Investigational Site
      • San Antonio, Texas, United States, 78229
        • Warner Chilcott Investigational Site
    • Utah
      • Magna, Utah, United States, 84044
        • Warner Chilcott Investigational Site
      • Salt Lake City, Utah, United States, 84109
        • Warner Chilcott Investigational Site
      • Salt Lake City, Utah, United States, 84121
        • Warner Chilcott Investigational Site
      • West Valley City, Utah, United States, 84120
        • 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

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

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Norethindrone/ethinyl estradiol
1 tablet per day
Drug: Norethindrone/ethinyl estradiol
1 tablet per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pearl Index, 18-35 Years, MITT Population
Time Frame: 13 cycles (28 days each), approximately 364 days
Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment
13 cycles (28 days each), approximately 364 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population
Time Frame: 12 cycles (28 days each), approximately 336 days
12 cycles (28 days each), approximately 336 days
Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population
Time Frame: 12 cycles (28 days each), approximately 336 days
Each IB episode has a unique duration, with 0, 1, 2, 3 or more episodes per cycle. To obtain "mean median duration" of episodes during a cycle, take the median duration of all episodes in each cycle. If there are no episodes in the cycle, then median duration is undefined/missing for that cycle. 1 episode - median duration = duration of that episode, 2 episodes - median duration = average of 2 durations, more than 2 episodes, calculated in usual way for median of an ordered set of numbers. Once median determined for each cycle/subject, the mean & SD of those quantities calculated.
12 cycles (28 days each), approximately 336 days

Collaborators and Investigators

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

Sponsor

Warner Chilcott

Investigators

  • Study Director: Herman Ellman, 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, 2007

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

February 1, 2009

Study Registration Dates

First Submitted

May 22, 2007

First Submitted That Met QC Criteria

May 23, 2007

First Posted (ESTIMATE)

May 24, 2007

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-00207

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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