Phase 3
N=1,700
Study of Safety and Efficacy of an Oral Contraceptive
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT00477633 ↗Enrolled (actual)
1,700
Serious AEs
1.2%
Results posted
Jan 2011
Primary outcome: Primary: Pearl Index, 18-35 Years, MITT Population — 1.903 Pearl Index
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Norethindrone/ethinyl estradiol (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Warner Chilcott
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pearl Index, 18-35 Years, MITT Population |
1.903 | — |
| SECONDARY Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population |
1.19 | — |
| SECONDARY Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population |
3.52 | — |
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.
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
- BMI>35
Data sourced from ClinicalTrials.gov (NCT00477633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.