Study of Safety and Efficacy of an Oral Contraceptive

NCT00477633 | Completed Phase 3 Results

• 1 other identifier: PR-00207
• Study Type: interventional
• Target: 1,700
• Locations: 1 country
• Sites: 63

Brief Summary

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.

Conditions

Contraception

Keywords

Contraception

Outcome Measures

Primary Outcomes (1)

• Pearl Index, 18-35 Years, MITT Population

  Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment

  13 cycles (28 days each), approximately 364 days

Secondary Outcomes (2)

• Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population

  12 cycles (28 days each), approximately 336 days

• Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population

  12 cycles (28 days each), approximately 336 days

Study Arms (1)

Norethindrone/ethinyl estradiol

EXPERIMENTAL

1 tablet per day

Drug: Norethindrone/ethinyl estradiol

Interventions

Norethindrone/ethinyl estradiol DRUG

1 tablet per day

Norethindrone/ethinyl estradiol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Women
• Age 18-45
• At risk for pregnancy
• History of regular cycles

You may not qualify if:

• Contraindications for use of hormonal contraception
• Conditions which affect the absorption or metabolism of steroid hormones
• BMI\>35

Sponsors & Collaborators

• Warner Chilcott: lead

Study Sites (63)

Warner Chilcott Investigational Site

Chandler, Arizona, 85224, United States

Location

Warner Chilcott Investigational Site

Phoenix, Arizona, 85032, United States

Location

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Phoenix, Arizona, 85037, United States

Location

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Phoenix, Arizona, 85050, United States

Location

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Tempe, Arizona, 85282, United States

Location

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Tucson, Arizona, 85712, United States

Location

Warner Chilcott Investigational Site

San Diego, California, 92103, United States

Location

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San Diego, California, 92108, United States

Location

Warner Chilcott Investigational Site

Vista, California, 92083, United States

Location

Warner Chilcott Investigational Site

Castle Rock, Colorado, 80108, United States

Location

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Denver, Colorado, 80218, United States

Location

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Lakewood, Colorado, 80228, United States

Location

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Boynton Beach, Florida, 33472, United States

Location

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Brooksville, Florida, 34613, United States

Location

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Clearwater, Florida, 33759, United States

Location

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Gainesville, Florida, 32607, United States

Location

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Jacksonville, Florida, 32207, United States

Location

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Leesburg, Florida, 34748, United States

Location

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Miami, Florida, 33143, United States

Location

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Miami, Florida, 33186, United States

Location

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Pembroke Pines, Florida, 33021, United States

Location

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St. Petersburg, Florida, 33709, United States

Location

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West Palm Beach, Florida, 33401, United States

Location

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West Palm Beach, Florida, 33409, United States

Location

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Decatur, Georgia, 30034, United States

Location

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Champaign, Illinois, 61820, United States

Location

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Peoria, Illinois, 61615, United States

Location

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Indianapolis, Indiana, 46250, United States

Location

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Arkansas City, Kansas, 67005, United States

Location

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Wichita, Kansas, 67207, United States

Location

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Lexington, Kentucky, 40509, United States

Location

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Louisville, Kentucky, 40291, United States

Location

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Amite, Louisiana, 70422, United States

Location

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Marrero, Louisiana, 70072, United States

Location

Warner Chilcott Investigational Site

Chaska, Minnesota, 55318, United States

Location

Warner Chilcott Investigational Site

Berlin, New Jersey, 08009, United States

Location

Warner Chilcott Investigational Site

Edison, New Jersey, 08817, United States

Location

Warner Chilcott Investigational Site

Lawrenceville, New Jersey, 08648, United States

Location

Warner Chilcott Investigational Site

Moorestown, New Jersey, 08051, United States

Location

Warner Chilcott Investigational Site

New York, New York, 10016, United States

Location

Warner Chilcott Investigational Site

Cary, North Carolina, 27511, United States

Location

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New Bern, North Carolina, 28562, United States

Location

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Raleigh, North Carolina, 27612, United States

Location

Warner Chilcott Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

Warner Chilcott Investigational Site

Cleveland, Ohio, 44122, United States

Location

Warner Chilcott Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

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Medford, Oregon, 97504, United States

Location

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Philadelphia, Pennsylvania, 19114, United States

Location

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Pittsburgh, Pennsylvania, 15206, United States

Location

Warner Chilcott Investigational Site

Pottstown, Pennsylvania, 19464-3224, United States

Location

Warner Chilcott Investigational Site

Columbia, South Carolina, 29201, United States

Location

Warner Chilcott Investigational Site

Austin, Texas, 78748, United States

Location

Warner Chilcott Investigational Site

Austin, Texas, 78759, United States

Location

Warner Chilcott Investigational Site

Dallas, Texas, 75234, United States

Location

Warner Chilcott Investigational Site

Houston, Texas, 77030, United States

Location

Warner Chilcott Investigational Site

San Antonio, Texas, 78229, United States

Location

Warner Chilcott Investigational Site

Magna, Utah, 84044, United States

Location

Warner Chilcott Investigational Site

Salt Lake City, Utah, 84109, United States

Location

Warner Chilcott Investigational Site

Salt Lake City, Utah, 84121, United States

Location

Warner Chilcott Investigational Site

West Valley City, Utah, 84120, United States

Location

Warner Chilcott Investigational Site

Norfolk, Virginia, 23507, United States

Location

Warner Chilcott Investigational Site

Richmond, Virginia, 23233, United States

Location

Warner Chilcott Investigational Site

Virginia Beach, Virginia, 23456, United States

Location

MeSH Terms

Interventions

ovcon 35

Results Point of Contact

• Title: Grexan Wulff, Manager Regulatory Affairs
• Organization: Warner Chilcott

gwulff@wcrx.com

973-442-3376

Study Officials

• Herman Ellman

  Sponsor GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2007
• First Posted: May 24, 2007
• Study Start: June 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: February 1, 2009
• Last Updated: April 22, 2013
• Results First Posted: January 24, 2011

Record last verified: 2013-04

Locations

US (63)