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Sponsored by: |
Warner Chilcott |
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Information provided by: | Warner Chilcott |
ClinicalTrials.gov Identifier: | NCT00391807 |
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.
Condition | Intervention | Phase |
---|---|---|
Contraception |
Drug: Norethindrone acetate/ethinyl estradiol |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol |
Estimated Enrollment: | 1600 |
Study Start Date: | November 2006 |
Study Completion Date: | September 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
study drug: Experimental
Norethindrone/Ethinyl Estradiol
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Drug: Norethindrone acetate/ethinyl estradiol
one tablet per day
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Herman Ellman, MD | Sponsor GmbH |
Responsible Party: | Warner Chilcott ( Dr. Herman Ellman ) |
Study ID Numbers: | PR-05806 |
Study First Received: | October 20, 2006 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00391807 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Contraception |
Estrogens Contraceptive Agents Hormone Antagonists Estradiol valerate Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Ethinyl Estradiol |
Estradiol 17 beta-cypionate Hormones Estradiol Norethindrone Estradiol 3-benzoate Polyestradiol phosphate Norethindrone acetate |
Estrogens Contraceptive Agents Contraceptives, Oral Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Ethinyl Estradiol Reproductive Control Agents |
Hormones Estradiol Pharmacologic Actions Norethindrone Therapeutic Uses Contraceptives, Oral, Synthetic Norethindrone acetate |