Study of Bleeding With Extended Administration of an Oral Contraceptive

NCT ID: NCT00338052

Last Updated: 2008-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-05-31

Brief Summary

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This is an non-comparative study. There is no statistical hypothesis. The effects of extension of treatment on bleeding will be recorded and described.

Detailed Description

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Conditions

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Contraception

Keywords

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Contraception

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Norethindrone 1 mg / ethinyl estradiol 20 mcg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy women
* Age 25-40
* History of regular cycles

Exclusion Criteria

* Current or recent (within 2 months) users of hormonal contraceptives
* Contraindications for use of hormonal contraception
* Conditions which affect the absorption or metabolism of steroid hormones
* BMI \> 35
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 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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Warner Chilcott

Principal Investigators

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Herman Ellman, MD

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

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Warner Chilcott Investigational Site

Phoenix, Arizona, United States

Site Status

Warner Chilcott Investigational Site

Phoenix, Arizona, United States

Site Status

Warner Chilcott Investigational Site

Tempe, Arizona, United States

Site Status

Warner Chilcott Investigational Site

Carmichael, California, United States

Site Status

Warner Chilcott Investigational Site

Boynton Beach, Florida, United States

Site Status

Warner Chilcott Investigational Site

Leesburg, Florida, United States

Site Status

Warner Chilcott Investigational Site

Miami, Florida, United States

Site Status

Warner Chilcott Investigational Site

Miami, Florida, United States

Site Status

Warner Chilcott Investigational Site

West Palm Beach, Florida, United States

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Warner Chilcott Investigational Site

Decatur, Georgia, United States

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Warner Chilcott Investigational Site

Roswell, Georgia, United States

Site Status

Warner Chilcott Investigational Site

Peoria, Illinois, United States

Site Status

Warner Chilcott Investigational Site

Lexington, Kentucky, United States

Site Status

Warner Chilcott Investigational Site

Louisville, Kentucky, 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

Philadelphia, Pennsylvania, United States

Site Status

Warner Chilcott Investigational Site

Greenville, South Carolina, United States

Site Status

Warner Chilcott Investigational Site

Pleasant Grove, Utah, United States

Site Status

Warner Chilcott Investigational Site

Salt Lake City, Utah, United States

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Warner Chilcott Investigational Site

Sandy City, Utah, 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-02306

Identifier Type: -

Identifier Source: org_study_id