Phase 3
N=1,683
Study of Safety and Efficacy of an Oral Contraceptive
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT00391807 ↗Enrolled (actual)
1,683
Serious AEs
0.9%
Results posted
Dec 2010
Primary outcome: Primary: Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population, — 2.554 Pregnancy Rate
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Norethindrone acetate/ethinyl estradiol (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Warner Chilcott
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population, |
2.554 | — |
| PRIMARY Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population |
2.167 | — |
| SECONDARY Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population |
3.21 | — |
| SECONDARY Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population |
2.00 | — |
| SECONDARY Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population |
1.81 | — |
| SECONDARY Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population |
34.8 | — |
| SECONDARY Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population |
25.0 | — |
| SECONDARY Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population |
22.4 | — |
| SECONDARY Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population |
3.93 | — |
| SECONDARY Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population |
3.99 | — |
| SECONDARY Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population |
3.85 | — |
| SECONDARY Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population |
4.57 | — |
| SECONDARY Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population |
3.00 | — |
| SECONDARY Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population |
3.36 | — |
| SECONDARY Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population |
30.7 | — |
| SECONDARY Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population |
42.9 | — |
| SECONDARY Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population |
49.1 | — |
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 (NCT00391807). 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.