Study of Safety and Efficacy of an Oral Contraceptive - Full Text View

Purpose

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.

Condition	Intervention	Phase
Prevention of Pregnancy	Drug: Norethindrone Acetate/Ethinyl Estradiol 24 Days Drug: Norethindrone Acetate /Ethinyl Estradiol 21 Days	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Open Label, Randomized, Comparator-Controlled Study of the Contraceptive Efficacy of Norethindrone Acetate (NA) and Ethinyl Estradiol (EE)

Resource links provided by NLM:

Drug Information available for: Estradiol Norethindrone acetate Ethinyl Estradiol Norethindrone Estradiol cypionate Estradiol valerate Estradiol acetate Estradiol hemihydrate

U.S. FDA Resources

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:

Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population [ Time Frame: 5.6 months (6 - 28 day cycles) ] [ Designated as safety issue: No ]
Pearl Index = 1300 * number of pregnancies/number of women-cycles of treatment

Secondary Outcome Measures:

Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population [ Time Frame: 5.6 months (6 - 28 day cycles) ] [ Designated as safety issue: No ]
Self-reported via patient completed diary (none - no vaginal bleeding, light - less than normal menstruation, normal - like normal menstruation, heavy - more than normal menstruation) along with daily use of sanitary protection (other than panty liners). Light bleeding requiring no more than single pad or tampon will be spotting.

Enrollment:	938
Study Start Date:	January 2004
Study Completion Date:	November 2004
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 24 Day NA/EE Norethindrone acetate 1 mg /ethinyl estradiol 20 mcg for 24 days of each 28 day cycle	Drug: Norethindrone Acetate/Ethinyl Estradiol 24 Days One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets
Active Comparator: 21 Day NA/EE Norethindrone acetate 1 mg/ethinyl estradiol 20 mcg for 21 days of each 28 day cycle	Drug: Norethindrone Acetate /Ethinyl Estradiol 21 Days One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets Other Name: 21 Day NA/EE

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932321

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Locations

United States, Alabama
Warner Chilcott Investigational Site
Birmingham, Alabama, United States, 35233
United States, Arizona
Warner Chilcott Investigational Site
Phoenix, Arizona, United States, 85031
Warner Chilcott Investigational Site
Phoenix, Arizona, United States, 85014
United States, California
Warner Chilcott Investigational Site
Chico, California, United States, 95929
Warner Chilcott Investigational Site
Los Angeles, California, United States, 90033
Warner Chilcott Investigational Site
San Diego, California, United States, 92103
Warner Chilcott Investigational Site
San Diego, California, United States, 92108
United States, Colorado
Warner Chilcott Investigational Site
Denver, Colorado, United States, 80202
United States, Florida
Warner Chilcott Investigational Site
Boynton Beach, Florida, United States, 33437
Warner Chilcott Investigational Site
Jacksonville, Florida, United States, 32207
Warner Chilcott Investigational Site
Miami, Florida, United States, 33186
Warner Chilcott Investigational Site
Palm Harbor, Florida, United States, 34684
Warner Chilcott Investigational Site
Venice, Florida, United States, 34285
Warner Chilcott Investigational Site
West Palm Beach, Florida, United States, 33409
United States, Georgia
Warner Chilcott Investigational Site
Decatur, Georgia, United States, 30033
Warner Chilcott Investigational Site
Decatur, Georgia, United States, 30034
Warner Chilcott Investigational Site
Powder Springs, Georgia, United States, 30127
Warner Chilcott Investigational Site
Roswell, Georgia, United States, 30075
Warner Chilcott Investigational Site
Savannah, Georgia, United States, 31405
United States, Kentucky
Warner Chilcott Investigational Site
Louisville, Kentucky, United States, 40202
United States, Missouri
Warner Chilcott Investigational Site
Kansas City, Missouri, United States, 64112
Warner Chilcott Investigational Site
St. Louis, Missouri, United States, 63117
United States, North Carolina
Warner Chilcott Investigational Site
New Bern, North Carolina, United States, 28562
Warner Chilcott Investigational Site
Winston Salem, North Carolina, United States, 27103
United States, Pennsylvania
Warner Chilcott Investigational Site
Allentown, Pennsylvania, United States, 18104
Warner Chilcott Investigational Site
Philadelphia, Pennsylvania, United States, 19114
Warner Chilcott Investigational Site
Pittsburgh, Pennsylvania, United States, 15206
United States, South Carolina
Warner Chilcott Investigational Site
Charleston, South Carolina, United States, 29425
Warner Chilcott Investigational Site
Greenville, South Carolina, United States, 29605
United States, Utah
Warner Chilcott Investigational Site
Sandy, Utah, United States, 84070
United States, Virginia
Warner Chilcott Investigational Site
Norfolk, Virginia, United States, 23507
Warner Chilcott Investigational Site
Richmond, Virginia, United States, 23233
Warner Chilcott Investigational Site
Virginia Beach, Virginia, United States, 23456
United States, Washington
Warner Chilcott Investigational Site
Seattle, Washington, United States, 98105

Sponsors and Collaborators

Warner Chilcott

Investigators

Study Director:

Herman Ellman, MD

Sponsor GmbH

More Information

No publications provided

Responsible Party:	Warner Chilcott
ClinicalTrials.gov Identifier:	NCT00932321 History of Changes
Other Study ID Numbers:	PR-03903
Study First Received:	June 30, 2009
Results First Received:	February 22, 2011
Last Updated:	April 15, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Warner Chilcott:

Contraception

Additional relevant MeSH terms:

Contraceptive Agents
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Norethindrone
Norethindrone acetate
Contraceptives, Oral
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol

Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on May 16, 2013