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...
Date First Received: June 30, 2009
Last Updated: July 1, 2009
Verified by: Warner Chilcott, July 2009
Clinical Trial Phase: Phase 3 | Start Date: January 2004
Overall Status: Completed
Estimated Enrollment: 939
Brief Summary
Official Title: “Open Label, Randomized, Comparator-Controlled Study of the Contraceptive Efficacy of Norethindrone Acetate and Ethinyl Estradiol”
Condition Keyword(s):
Additional Keyword(s) Provided by Sponsor:
Intervention(s):
Intervention MeSH Term(s), Assigned with an Experimental Algorithm:
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.
Study Type: Interventional
Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Study Primary Completion Date: November 2004
Intervention(s) in this Clinical Trial
- Drug: Norethindrone acetate/ethinyl estradiol
- One tablet per day
- Drug: Loestrin
- One tablet per day
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Norethindrone acetate/ethinyl estradiol
- Active Comparator: 2
- Loestrin 1/20 (NETA 1 mg/EE 20 + placebo)
Outcome Measures for this Clinical Trial
Primary Measures
- Pregnancy rate among women 18 to 35 years old, expressed in terms of the Pearl Index defined as the number of pregnancies per 100 women-years of treatment.
- Time Frame: 6 Cycles (5.5 months)
Safety Issue?: No
- Time Frame: 6 Cycles (5.5 months)
Secondary Measures
- Descriptive parameters of bleeding/spotting, safety and tolerability.
- Time Frame: 6 Cycles (5.5 months)
Safety Issue?: Yes
- Time Frame: 6 Cycles (5.5 months)
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 45 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Warner Chilcott
Overall Clinical Trial Officials and Contacts
Herman Ellman, MD Study Director Sponsor GmbH
Additional Information
Information obtained from ClinicalTrials.gov on September 01, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00932321
Study ID Number: PR-03903
ClinicalTrials.gov Identifier: NCT00932321
Health Authority: United States: Food and Drug Administration
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