Study of Safety and Efficacy of an Oral Contraceptive
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...
Brief Summary
Official Title: “Open Label, Randomized, Comparator-Controlled Study of the Contraceptive Efficacy of Norethindrone Acetate (NA) and Ethinyl Estradiol (EE)”
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, 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 24 Days
- One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets
- Drug: Norethindrone Acetate /Ethinyl Estradiol 21 Days
- One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 24 Day NA/EE
- Norethindrone acetate 1 mg /ethinyl estradiol 20 mcg for 24 days of each 28 day cycle
- Active Comparator: 21 Day NA/EE
- Norethindrone acetate 1 mg/ethinyl estradiol 20 mcg for 21 days of each 28 day cycle
Outcome Measures for this Clinical Trial
Primary 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)
Safety Issue?: No
- Time Frame: 5.6 months (6 - 28 day cycles)
Secondary Measures
- Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population
- Time Frame: 5.6 months (6 - 28 day cycles)
Safety Issue?: No
- Time Frame: 5.6 months (6 - 28 day cycles)
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 Investigator Information
Lead Investigator: Warner Chilcott Industry
Overall Clinical Trial Officials and Contacts
Herman Ellman, MD Study Director Sponsor GmbH
Additional Information
Information obtained from ClinicalTrials.gov on February 02, 2012
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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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00932321
