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Study of Safety and Efficacy of an Oral Contraceptive

NCT ID: NCT00932321

Last Updated: 2013-04-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

938 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2004-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Prevention of Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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24 Day NA/EE

Norethindrone acetate 1 mg /ethinyl estradiol 20 mcg for 24 days of each 28 day cycle

Group Type EXPERIMENTAL

Norethindrone Acetate/Ethinyl Estradiol 24 Days

Intervention Type DRUG

One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets

21 Day NA/EE

Norethindrone acetate 1 mg/ethinyl estradiol 20 mcg for 21 days of each 28 day cycle

Group Type ACTIVE_COMPARATOR

Norethindrone Acetate /Ethinyl Estradiol 21 Days

Intervention Type DRUG

One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets

Interventions

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Norethindrone Acetate/Ethinyl Estradiol 24 Days

One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets

Intervention Type DRUG

Norethindrone Acetate /Ethinyl Estradiol 21 Days

One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets

Intervention Type DRUG

Other Intervention Names

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21 Day NA/EE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Warner Chilcott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herman Ellman, MD

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

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Warner Chilcott Investigational Site

Birmingham, Alabama, United States

Site Status

Warner Chilcott Investigational Site

Phoenix, Arizona, United States

Site Status

Warner Chilcott Investigational Site

Phoenix, Arizona, United States

Site Status

Warner Chilcott Investigational Site

Chico, California, United States

Site Status

Warner Chilcott Investigational Site

Los Angeles, California, United States

Site Status

Warner Chilcott Investigational Site

San Diego, California, United States

Site Status

Warner Chilcott Investigational Site

San Diego, California, United States

Site Status

Warner Chilcott Investigational Site

Denver, Colorado, United States

Site Status

Warner Chilcott Investigational Site

Boynton Beach, Florida, United States

Site Status

Warner Chilcott Investigational Site

Jacksonville, Florida, United States

Site Status

Warner Chilcott Investigational Site

Miami, Florida, United States

Site Status

Warner Chilcott Investigational Site

Palm Harbor, Florida, United States

Site Status

Warner Chilcott Investigational Site

Venice, Florida, United States

Site Status

Warner Chilcott Investigational Site

West Palm Beach, Florida, United States

Site Status

Warner Chilcott Investigational Site

Decatur, Georgia, United States

Site Status

Warner Chilcott Investigational Site

Decatur, Georgia, United States

Site Status

Warner Chilcott Investigational Site

Powder Springs, Georgia, United States

Site Status

Warner Chilcott Investigational Site

Roswell, Georgia, United States

Site Status

Warner Chilcott Investigational Site

Savannah, Georgia, United States

Site Status

Warner Chilcott Investigational Site

Louisville, Kentucky, United States

Site Status

Warner Chilcott Investigational Site

Kansas City, Missouri, United States

Site Status

Warner Chilcott Investigational Site

St Louis, Missouri, United States

Site Status

Warner Chilcott Investigational Site

New Bern, North Carolina, United States

Site Status

Warner Chilcott Investigational Site

Winston-Salem, North Carolina, United States

Site Status

Warner Chilcott Investigational Site

Allentown, Pennsylvania, United States

Site Status

Warner Chilcott Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Warner Chilcott Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

Warner Chilcott Investigational Site

Charleston, South Carolina, United States

Site Status

Warner Chilcott Investigational Site

Greenville, South Carolina, United States

Site Status

Warner Chilcott Investigational Site

Sandy City, Utah, United States

Site Status

Warner Chilcott Investigational Site

Norfolk, Virginia, United States

Site Status

Warner Chilcott Investigational Site

Richmond, Virginia, United States

Site Status

Warner Chilcott Investigational Site

Virginia Beach, Virginia, United States

Site Status

Warner Chilcott Investigational Site

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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PR-03903

Identifier Type: -

Identifier Source: org_study_id

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