Trials / Completed
CompletedNCT01107106
Safety, Tolerability, and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Women
Prospective Observational Single Arm Open-Label Multicenter Study to Assess the Safety, Tolerability and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Adult Women
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 579 (actual)
- Sponsor
- HRA Pharma · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
Summary
The purpose of this observational study is to assess the safety and tolerability of ellaOne® in routine conditions of use for emergency contraception in postmenarcheal adolescents and adult women who want to prevent pregnancy up to 5 days after unprotected sexual intercourse.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ellaOne® (ulipristal acetate) | one single oral dose (30 mg tablet) |
| DRUG | ellaOne® (ulipristal acetate) | one single oral dose (30 mg tablet) |
Timeline
- Start date
- 2010-05-01
- Primary completion
- 2013-01-01
- Completion
- 2013-02-01
- First posted
- 2010-04-20
- Last updated
- 2013-05-15
Locations
6 sites across 3 countries: United States, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT01107106. Inclusion in this directory is not an endorsement.