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Study of Safety and Efficacy of an Oral Contraceptive

Information source: Warner Chilcott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prevention of Pregnancy

Intervention: Norethindrone Acetate/Ethinyl Estradiol 24 Days (Drug); Norethindrone Acetate /Ethinyl Estradiol 21 Days (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Warner Chilcott

Official(s) and/or principal investigator(s):
Herman Ellman, MD, Study Director, Affiliation: Sponsor GmbH

Summary

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.

Clinical Details

Official title: Open Label, Randomized, Comparator-Controlled Study of the Contraceptive Efficacy of Norethindrone Acetate (NA) and Ethinyl Estradiol (EE)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population

Secondary outcome: Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Warner Chilcott Investigational Site, Birmingham, Alabama 35233, United States

Warner Chilcott Investigational Site, Phoenix, Arizona 85014, United States

Warner Chilcott Investigational Site, Phoenix, Arizona 85031, United States

Warner Chilcott Investigational Site, Chico, California 95929, United States

Warner Chilcott Investigational Site, Los Angeles, California 90033, United States

Warner Chilcott Investigational Site, San Diego, California 92103, United States

Warner Chilcott Investigational Site, San Diego, California 92108, United States

Warner Chilcott Investigational Site, Denver, Colorado 80202, United States

Warner Chilcott Investigational Site, Boynton Beach, Florida 33437, United States

Warner Chilcott Investigational Site, Jacksonville, Florida 32207, United States

Warner Chilcott Investigational Site, Miami, Florida 33186, United States

Warner Chilcott Investigational Site, Palm Harbor, Florida 34684, United States

Warner Chilcott Investigational Site, Venice, Florida 34285, United States

Warner Chilcott Investigational Site, West Palm Beach, Florida 33409, United States

Warner Chilcott Investigational Site, Decatur, Georgia 30033, United States

Warner Chilcott Investigational Site, Decatur, Georgia 30034, United States

Warner Chilcott Investigational Site, Powder Springs, Georgia 30127, United States

Warner Chilcott Investigational Site, Roswell, Georgia 30075, United States

Warner Chilcott Investigational Site, Savannah, Georgia 31405, United States

Warner Chilcott Investigational Site, Louisville, Kentucky 40202, United States

Warner Chilcott Investigational Site, Kansas City, Missouri 64112, United States

Warner Chilcott Investigational Site, St. Louis, Missouri 63117, United States

Warner Chilcott Investigational Site, New Bern, North Carolina 28562, United States

Warner Chilcott Investigational Site, Winston Salem, North Carolina 27103, United States

Warner Chilcott Investigational Site, Allentown, Pennsylvania 18104, United States

Warner Chilcott Investigational Site, Philadelphia, Pennsylvania 19114, United States

Warner Chilcott Investigational Site, Pittsburgh, Pennsylvania 15206, United States

Warner Chilcott Investigational Site, Charleston, South Carolina 29425, United States

Warner Chilcott Investigational Site, Greenville, South Carolina 29605, United States

Warner Chilcott Investigational Site, Sandy, Utah 84070, United States

Warner Chilcott Investigational Site, Norfolk, Virginia 23507, United States

Warner Chilcott Investigational Site, Richmond, Virginia 23233, United States

Warner Chilcott Investigational Site, Virginia Beach, Virginia 23456, United States

Warner Chilcott Investigational Site, Seattle, Washington 98105, United States

Additional Information

Starting date: January 2004
Last updated: April 15, 2013

Page last updated: August 23, 2015

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