Phase 3
N=938
Study of Safety and Efficacy of an Oral Contraceptive
Prevention of Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT00932321 ↗Enrolled (actual)
938
Serious AEs
0.3%
Results posted
Mar 2011
Primary outcome: Primary: Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population — 1.823; 2.978 Pearl Index
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Norethindrone Acetate/Ethinyl Estradiol 24 Days (Drug); Norethindrone Acetate /Ethinyl Estradiol 21 Days (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Warner Chilcott
- Primary completion
- Nov 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population |
1.823; 2.978 | — |
| SECONDARY Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population |
6.31; 7.31 | 0.311 |
Summary
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.
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 (NCT00932321). 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.