Study of Safety and Efficacy of an Oral Contraceptive

Study Overview
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Brief Summary
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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.

Official Title
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Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol

Conditions
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Contraception

Intervention / Treatment
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* Drug: Norethindrone acetate/ethinyl estradiol


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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study drug<br>Norethindrone/Ethinyl Estradiol | Drug: Norethindrone acetate/ethinyl estradiol<br>* one tablet per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population, |  | 13 cycles, 28 days each (1 year) | 
| Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population |  | 13 Cycles, 28 days each (1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population | MITT Population | 2 Cycles, 28 days each (56 days) | 
| Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population | MITT Population | 6 cycles, 28 days each (168 days) | 
| Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population | MITT Population | 13 cycles, 28 days each (1 year) | 
| Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population |  | 2 cycles, 28 days each (56 days) | 
| Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population |  | 6 cycles, 28 days each (168 days) | 
| Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population |  | 13 cycles, 28 days each (1 year) | 
| Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population |  | 2 cycles, 28 days each (56 days) | 
| Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population |  | 6 cycles, 28 days each (168 days) | 
| Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population |  | 12 cycles, 28 days each (336 days) | 
| Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population |  | 2 cycles, 28 days each (56 days) | 
| Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population |  | 6 cycles, 28 days each (168 days) | 
| Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population |  | 13 cycles, 28 days each (1 year) | 
| Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population |  | 2 cycles, 28 days each (56 days) | 
| Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population |  | 6 cycles, 28 days each (168 days) | 
| Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population |  | 13 cycles, 28 days each (1 year) | 

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