Trials / Completed
CompletedNCT00477633
Study of Safety and Efficacy of an Oral Contraceptive
An Open Label Study of the Contraceptive Efficacy of Norethindrone and Ethinyl Estradiol.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,700 (actual)
- Sponsor
- Warner Chilcott · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Norethindrone/ethinyl estradiol | 1 tablet per day |
Timeline
- Start date
- 2007-06-01
- Primary completion
- 2009-01-01
- Completion
- 2009-02-01
- First posted
- 2007-05-24
- Last updated
- 2013-04-22
- Results posted
- 2011-01-24
Locations
63 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00477633. Inclusion in this directory is not an endorsement.