Trials / Unknown
UnknownNCT01635452
A Prospective Multicenter Non-interventional Study of Women Treated With ESMYA (Ulipristal Acetate) as Pre-operative Treatment of Moderate to Severe Symptoms of Uterine Fibroids
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,500 (estimated)
- Sponsor
- PregLem SA · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, prospective, non-interventional study of patients who have been diagnosed with moderate to severe symptoms of uterine fibroids and are initiating a pre-operative treatment with ESMYA. The objectives of the study are to characterize and describe treatment with ESMYA and to evaluate the safety, effectiveness, and HRQL outcomes in this population
Conditions
Timeline
- Start date
- 2012-05-01
- Primary completion
- 2014-04-01
- Completion
- 2016-03-01
- First posted
- 2012-07-09
- Last updated
- 2015-01-27
Locations
75 sites across 10 countries: Austria, France, Germany, Hungary, Italy, Poland, Portugal, Romania, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01635452. Inclusion in this directory is not an endorsement.