Study of Safety and Efficacy of an Oral Contraceptive

Study Overview
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Brief Summary
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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.

Official Title
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Open Label, Randomized, Comparator-Controlled Study of the Contraceptive Efficacy of Norethindrone Acetate (NA) and Ethinyl Estradiol (EE)

Conditions
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Prevention of Pregnancy

Intervention / Treatment
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* Drug: Norethindrone Acetate/Ethinyl Estradiol 24 Days
* Drug: Norethindrone Acetate /Ethinyl Estradiol 21 Days


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 24 Day NA/EE<br>Norethindrone acetate 1 mg /ethinyl estradiol 20 mcg for 24 days of each 28 day cycle | Drug: Norethindrone Acetate/Ethinyl Estradiol 24 Days<br>* One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets<br>|
| Active Comparator: 21 Day NA/EE<br>Norethindrone acetate 1 mg/ethinyl estradiol 20 mcg for 21 days of each 28 day cycle | Drug: Norethindrone Acetate /Ethinyl Estradiol 21 Days<br>* One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets<br>* Other names: 21 Day NA/EE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population | Pearl Index = 1300 * number of pregnancies/number of women-cycles of treatment | 5.6 months (6 - 28 day cycles) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population | Self-reported via patient completed diary (none - no vaginal bleeding, light - less than normal menstruation, normal - like normal menstruation, heavy - more than normal menstruation) along with daily use of sanitary protection (other than panty liners). Light bleeding requiring no more than single pad or tampon will be spotting. | 5.6 months (6 - 28 day cycles) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception