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Study of Bleeding With Extended Administration of an Oral Contraceptive

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ClinicalTrials.gov Identifier: NCT00338052
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : May 8, 2008
Sponsor:
Information provided by:
Warner Chilcott

Brief Summary:
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 or disease Intervention/treatment Phase
Contraception Drug: Norethindrone 1 mg / ethinyl estradiol 20 mcg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Study of Cycle Control With Extended Administration of Norethindrone Acetate 1 mg / Ethinyl Estradiol 20 Mcg Oral Tablets
Study Start Date : June 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control




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

Secondary Outcome Measures :
  1. Satisfaction


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00338052


Locations
United States, Arizona
Warner Chilcott Investigational Site
Phoenix, Arizona, United States, 85031
Warner Chilcott Investigational Site
Phoenix, Arizona, United States, 85050
Warner Chilcott Investigational Site
Tempe, Arizona, United States, 85283
United States, California
Warner Chilcott Investigational Site
Carmichael, California, United States, 95608
United States, Florida
Warner Chilcott Investigational Site
Boynton Beach, Florida, United States, 33437
Warner Chilcott Investigational Site
Leesburg, Florida, United States, 34748
Warner Chilcott Investigational Site
Miami, Florida, United States, 33143
Warner Chilcott Investigational Site
Miami, Florida, United States, 33186
Warner Chilcott Investigational Site
West Palm Beach, Florida, United States, 33401
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
Lexington, Kentucky, United States, 40509
Warner Chilcott Investigational Site
Louisville, Kentucky, United States, 40291
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
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
Pleasant Grove, Utah, United States, 84062
Warner Chilcott Investigational Site
Salt Lake City, Utah, United States, 84017
Warner Chilcott Investigational Site
Sandy, Utah, United States, 84070
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

Responsible Party: Herman Ellman, MD, Warner Chilcott
ClinicalTrials.gov Identifier: NCT00338052     History of Changes
Other Study ID Numbers: PR-02306
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: May 8, 2008
Last Verified: May 2008

Keywords provided by Warner Chilcott:
Contraception

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Norethindrone
Norethindrone acetate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral