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Study of Safety and Efficacy of an Oral Contraceptive

NCT ID: NCT00477633

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

1700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Norethindrone/ethinyl estradiol

1 tablet per day

Group Type EXPERIMENTAL

Norethindrone/ethinyl estradiol

Intervention Type DRUG

1 tablet per day

Interventions

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Norethindrone/ethinyl estradiol

1 tablet per day

Intervention Type DRUG

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

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

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Warner Chilcott Investigational Site

Chandler, Arizona, United States

Site Status

Warner Chilcott Investigational Site

Phoenix, Arizona, United States

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Warner Chilcott Investigational Site

Phoenix, Arizona, United States

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Warner Chilcott Investigational Site

Phoenix, Arizona, United States

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Warner Chilcott Investigational Site

Tempe, Arizona, United States

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Warner Chilcott Investigational Site

Tucson, Arizona, United States

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Warner Chilcott Investigational Site

San Diego, California, United States

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San Diego, California, United States

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Warner Chilcott Investigational Site

Vista, California, United States

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Warner Chilcott Investigational Site

Castle Rock, Colorado, United States

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Denver, Colorado, United States

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Lakewood, Colorado, United States

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Boynton Beach, Florida, United States

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Brooksville, Florida, United States

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Warner Chilcott Investigational Site

Clearwater, Florida, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Leesburg, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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St. Petersburg, Florida, United States

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Warner Chilcott Investigational Site

West Palm Beach, Florida, United States

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West Palm Beach, Florida, United States

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Warner Chilcott Investigational Site

Decatur, Georgia, United States

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Champaign, Illinois, United States

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Peoria, Illinois, United States

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Indianapolis, Indiana, United States

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Arkansas City, Kansas, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Amite, Louisiana, United States

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Marrero, Louisiana, United States

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Warner Chilcott Investigational Site

Chaska, Minnesota, United States

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Warner Chilcott Investigational Site

Berlin, New Jersey, United States

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Warner Chilcott Investigational Site

Edison, New Jersey, United States

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Warner Chilcott Investigational Site

Lawrenceville, New Jersey, United States

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Warner Chilcott Investigational Site

Moorestown, New Jersey, United States

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Warner Chilcott Investigational Site

New York, New York, United States

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Warner Chilcott Investigational Site

Cary, North Carolina, United States

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Warner Chilcott Investigational Site

New Bern, North Carolina, United States

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Warner Chilcott Investigational Site

Raleigh, North Carolina, United States

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Warner Chilcott Investigational Site

Winston-Salem, North Carolina, United States

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Warner Chilcott Investigational Site

Cleveland, Ohio, United States

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Warner Chilcott Investigational Site

Oklahoma City, Oklahoma, United States

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Warner Chilcott Investigational Site

Medford, Oregon, United States

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Warner Chilcott Investigational Site

Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Warner Chilcott Investigational Site

Pottstown, Pennsylvania, United States

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Warner Chilcott Investigational Site

Columbia, South Carolina, United States

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Warner Chilcott Investigational Site

Austin, Texas, United States

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Warner Chilcott Investigational Site

Austin, Texas, United States

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Warner Chilcott Investigational Site

Dallas, Texas, United States

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Warner Chilcott Investigational Site

Houston, Texas, United States

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Warner Chilcott Investigational Site

San Antonio, Texas, United States

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Warner Chilcott Investigational Site

Magna, Utah, United States

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Warner Chilcott Investigational Site

Salt Lake City, Utah, United States

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Warner Chilcott Investigational Site

Salt Lake City, Utah, United States

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Warner Chilcott Investigational Site

West Valley City, Utah, United States

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Warner Chilcott Investigational Site

Norfolk, Virginia, United States

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Warner Chilcott Investigational Site

Richmond, Virginia, United States

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Warner Chilcott Investigational Site

Virginia Beach, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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PR-00207

Identifier Type: -

Identifier Source: org_study_id

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