NCT00477633
Completed
Phase 3
An Open Label Study of the Contraceptive Efficacy of Norethindrone and Ethinyl Estradiol.
ConditionsContraception
InterventionsNorethindrone/ethinyl estradiol
Overview
- Phase
- Phase 3
- Intervention
- Norethindrone/ethinyl estradiol
- Conditions
- Contraception
- Sponsor
- Warner Chilcott
- Enrollment
- 1700
- Locations
- 1
- Primary Endpoint
- Pearl Index, 18-35 Years, MITT Population
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Norethindrone/ethinyl estradiol
1 tablet per day
Intervention: Norethindrone/ethinyl estradiol
Outcomes
Primary Outcomes
Pearl Index, 18-35 Years, MITT Population
Time Frame: 13 cycles (28 days each), approximately 364 days
Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment
Secondary Outcomes
- Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population(12 cycles (28 days each), approximately 336 days)
- Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population(12 cycles (28 days each), approximately 336 days)
Study Sites (1)
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