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Study of Bleeding With Extended Administration of an Oral Contraceptive
This study has been completed.
Sponsored by: Warner Chilcott
Information provided by: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00338052
  Purpose

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


Condition Intervention Phase
Contraception
 Drug: Norethindrone 1 mg / ethinyl estradiol 20 mcg
 Phase II

MedlinePlus related topics: Birth Control
Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Ethinyl estradiol Norethindrone acetate Norethindrone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Open-Label Study of Cycle Control With Extended Administration of Norethindrone Acetate 1 mg / Ethinyl Estradiol 20 Mcg Oral Tablets

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Number of bleeding/spotting days/episodes per treatment cycle

Secondary Outcome Measures:
  • Satisfaction

Enrollment: 207
Study Start Date: June 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   25 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338052

Locations
United States, Arizona
Warner Chilcott Investigational Site
Tempe, Arizona, United States, 85283
Warner Chilcott Investigational Site
Phoenix, Arizona, United States, 85031
Warner Chilcott Investigational Site
Phoenix, Arizona, United States, 85050
United States, California
Warner Chilcott Investigational Site
Carmichael, California, United States, 95608
United States, Florida
Warner Chilcott Investigational Site
Miami, Florida, United States, 33186
Warner Chilcott Investigational Site
Leesburg, Florida, United States, 34748
Warner Chilcott Investigational Site
West Palm Beach, Florida, United States, 33401
Warner Chilcott Investigational Site
Boynton Beach, Florida, United States, 33437
Warner Chilcott Investigational Site
Miami, Florida, United States, 33143
United States, Georgia
Warner Chilcott Investigational Site
Decatur, Georgia, United States, 30034
Warner Chilcott Investigational Site
Roswell, Georgia, United States, 30075
United States, Illinois
Warner Chilcott Investigational Site
Peoria, Illinois, United States, 61615
United States, Kentucky
Warner Chilcott Investigational Site
Louisville, Kentucky, United States, 40291
Warner Chilcott Investigational Site
Lexington, Kentucky, United States, 40509
United States, North Carolina
Warner Chilcott Investigational Site
Winston Salem, North Carolina, United States, 27103
Warner Chilcott Investigational Site
New Bern, North Carolina, United States, 28562
United States, Pennsylvania
Warner Chilcott Investigational Site
Philadelphia, Pennsylvania, United States, 19114
United States, South Carolina
Warner Chilcott Investigational Site
Greenville, South Carolina, United States, 29607
United States, Utah
Warner Chilcott Investigational Site
Salt Lake City, Utah, United States, 84017
Warner Chilcott Investigational Site
Sandy, Utah, United States, 84070
Warner Chilcott Investigational Site
Pleasant Grove, Utah, United States, 84062
United States, Virginia
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

Responsible Party: Warner Chilcott ( Herman Ellman, MD )
Study ID Numbers: PR-02306
Study First Received: June 16, 2006
Last Updated: May 7, 2008
ClinicalTrials.gov Identifier: NCT00338052  
Health Authority: United States: Food and Drug Administration

Keywords provided by Warner Chilcott:
Contraception

Study placed in the following topic categories:
Norethindrone
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Estradiol 17 beta-cypionate
 Polyestradiol phosphate
Hemorrhage
Estradiol
Norethindrone acetate

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

ClinicalTrials.gov processed this record on January 14, 2009



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