Study of Safety and Efficacy of an Oral Contraceptive

April 15, 2013 updated by: Warner Chilcott

Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate 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)

1683

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
      • Phoenix, Arizona, United States, 85050
        • Warner Chilcott Investigational Site
      • Phoenix, Arizona, United States, 85014
        • Warner Chilcott Investigational Site
      • Phoenix, Arizona, United States, 85032
        • Warner Chilcott Investigational Site
      • Phoenix, Arizona, United States, 85015
        • Warner Chilcott Investigational Site
      • Tempe, Arizona, United States, 85283
        • Warner Chilcott Investigational Site
      • Tempe, Arizona, United States
        • Warner Chilcott Investigational Site
      • Tucson, Arizona, United States, 85712
        • Warner Chilcott Investigational Site
    • California
      • Carmichael, California, United States, 95608
        • 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, 80218
        • Warner Chilcott Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Warner Chilcott Investigational Site
      • Clearwater, Florida, United States, 33759
        • Warner Chilcott Investigational Site
      • Jacksonville, Florida, United States, 32207
        • Warner Chilcott Investigational Site
      • Leesburg, Florida, United States, 34748
        • Warner Chilcott Investigational Site
      • Longwood, Florida, United States, 32779
        • Warner Chilcott Investigational Site
      • Miami, Florida, United States, 33143
        • Warner Chilcott Investigational Site
      • Miami, Florida, United States, 33186
        • Warner Chilcott Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Warner Chilcott Investigational Site
      • Pembroke Pines, Florida, United States
        • Warner Chilcott Investigational Site
      • Plantation, Florida, United States, 33324
        • 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
        • Warner Chilcott Investigational Site
    • Georgia
      • Roswell, Georgia, United States, 30075
        • Warner Chilcott Investigational Site
      • Sandy Springs, Georgia, United States, 30328
        • 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
        • Warner Chilcott Investigational Site
    • Kansas
      • Wichita, Kansas, United States
        • Warner Chilcott Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Warner Chilcott Investigational Site
      • Louisville, Kentucky, United States, 40291
        • Warner Chilcott Investigational Site
      • Louisville, Kentucky, United States, 40202
        • Warner Chilcott Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Warner Chilcott Investigational Site
      • Lawrenceville, New Jersey, United States, 08648
        • Warner Chilcott Investigational Site
      • Moorestown, New Jersey, United States, 08057
        • Warner Chilcott Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Warner Chilcott Investigational Site
    • North Carolina
      • Cary, North Carolina, United States
        • Warner Chilcott Investigational Site
      • New Bern, North Carolina, United States, 28562
        • Warner Chilcott Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • Warner Chilcott Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Warner Chilcott Investigational Site
      • Winston-Salem, North Carolina, United States
        • Warner Chilcott Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Warner Chilcott Investigational Site
      • Columbus, Ohio, United States, 43213
        • Warner Chilcott Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Warner Chilcott Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Warner Chilcott Investigational Site
      • Portland, Oregon, United States, 97239
        • 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
      • Charleston, South Carolina, United States, 29401
        • Warner Chilcott Investigational Site
      • Columbia, South Carolina, United States, 29201
        • Warner Chilcott Investigational Site
      • Greenville, South Carolina, United States, 29615
        • Warner Chilcott Investigational Site
    • Texas
      • Dallas, Texas, United States
        • 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, 84017
        • Warner Chilcott Investigational Site
      • Salt Lake City, Utah, United States, 84109
        • Warner Chilcott Investigational Site
      • Sandy, Utah, United States, 84070
        • Warner Chilcott Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23507-1627
        • 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
      • Spokane, Washington, United States, 99207
        • Warner Chilcott Investigational Site
      • Tacoma, Washington, United States, 98405
        • 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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study drug
Norethindrone/Ethinyl Estradiol
Drug: Norethindrone acetate/ethinyl estradiol
one tablet per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,
Time Frame: 13 cycles, 28 days each (1 year)
13 cycles, 28 days each (1 year)
Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population
Time Frame: 13 Cycles, 28 days each (1 year)
13 Cycles, 28 days each (1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population
Time Frame: 2 Cycles, 28 days each (56 days)
MITT Population
2 Cycles, 28 days each (56 days)
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population
Time Frame: 6 cycles, 28 days each (168 days)
MITT Population
6 cycles, 28 days each (168 days)
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population
Time Frame: 13 cycles, 28 days each (1 year)
MITT Population
13 cycles, 28 days each (1 year)
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population
Time Frame: 2 cycles, 28 days each (56 days)
2 cycles, 28 days each (56 days)
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population
Time Frame: 6 cycles, 28 days each (168 days)
6 cycles, 28 days each (168 days)
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population
Time Frame: 13 cycles, 28 days each (1 year)
13 cycles, 28 days each (1 year)
Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population
Time Frame: 2 cycles, 28 days each (56 days)
2 cycles, 28 days each (56 days)
Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population
Time Frame: 6 cycles, 28 days each (168 days)
6 cycles, 28 days each (168 days)
Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population
Time Frame: 12 cycles, 28 days each (336 days)
12 cycles, 28 days each (336 days)
Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population
Time Frame: 2 cycles, 28 days each (56 days)
2 cycles, 28 days each (56 days)
Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population
Time Frame: 6 cycles, 28 days each (168 days)
6 cycles, 28 days each (168 days)
Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population
Time Frame: 13 cycles, 28 days each (1 year)
13 cycles, 28 days each (1 year)
Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population
Time Frame: 2 cycles, 28 days each (56 days)
2 cycles, 28 days each (56 days)
Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population
Time Frame: 6 cycles, 28 days each (168 days)
6 cycles, 28 days each (168 days)
Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population
Time Frame: 13 cycles, 28 days each (1 year)
13 cycles, 28 days each (1 year)

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

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.

General Publications

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

November 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

October 20, 2006

First Submitted That Met QC Criteria

October 20, 2006

First Posted (Estimate)

October 24, 2006

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-05806

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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