Trials / Completed
CompletedNCT01569113
Assessment of Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® or Placebo.
A Prospective, Randomized, Double-blind Parallel-arm, Placebo-controlled Study to Assess the Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® (Ulipristal Acetate 30 mg) or Placebo.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- HRA Pharma · Industry
- Sex
- Female
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Accepted
Summary
The purposes of this study are to compare the effects on ovarian activity of quick starting a Combined Oral Contraceptive Pill (COCP) after ellaOne® or placebo intake.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon) | UPA: 30 mg, 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake |
| DRUG | placebo + ethinylestradiol/levonorgestrel | placebo: 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2012-08-01
- Completion
- 2012-08-01
- First posted
- 2012-04-02
- Last updated
- 2013-06-13
Locations
3 sites across 3 countries: Netherlands, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT01569113. Inclusion in this directory is not an endorsement.