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Study of Safety and Efficacy of an Oral Contraceptive

NCT ID: NCT00391807

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

1683 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-09-30

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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study drug

Norethindrone/Ethinyl Estradiol

Group Type EXPERIMENTAL

Norethindrone acetate/ethinyl estradiol

Intervention Type DRUG

one tablet per day

Interventions

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Norethindrone acetate/ethinyl estradiol

one 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, 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

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Warner Chilcott Investigational Site

Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tempe, Arizona, United States

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Tempe, Arizona, United States

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Tucson, Arizona, United States

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Carmichael, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Boynton Beach, Florida, United States

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Clearwater, Florida, United States

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Jacksonville, Florida, United States

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Leesburg, Florida, United States

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Longwood, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Pembroke Pines, Florida, United States

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Plantation, Florida, United States

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St. Petersburg, Florida, United States

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West Palm Beach, Florida, United States

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West Palm Beach, Florida, United States

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Roswell, Georgia, United States

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Sandy Springs, 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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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Berlin, New Jersey, United States

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Lawrenceville, New Jersey, United States

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Moorestown, New Jersey, United States

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Albuquerque, New Mexico, United States

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Cary, North Carolina, United States

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New Bern, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pottstown, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Greenville, South Carolina, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Magna, Utah, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Sandy City, Utah, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Warner Chilcott Investigational Site

Tacoma, Washington, United States

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Countries

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United States

References

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Nakajima ST, Pappadakis J, Archer DF. Body mass index does not affect the efficacy or bleeding profile during use of an ultra-low-dose combined oral contraceptive. Contraception. 2016 Jan;93(1):52-7. doi: 10.1016/j.contraception.2015.09.013. Epub 2015 Sep 26.

Reference Type DERIVED
PMID: 26410176 (View on PubMed)

Archer DF, Nakajima ST, Sawyer AT, Wentworth J, Trupin S, Koltun WD, Gilbert RD, Ellman H. Norethindrone acetate 1.0 milligram and ethinyl estradiol 10 micrograms as an ultra low-dose oral contraceptive. Obstet Gynecol. 2013 Sep;122(3):601-7. doi: 10.1097/AOG.0b013e3182a1741c.

Reference Type DERIVED
PMID: 23921878 (View on PubMed)

Other Identifiers

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PR-05806

Identifier Type: -

Identifier Source: org_study_id

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