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 (PREMYA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01635452|
Recruitment Status : Unknown
Verified January 2015 by PregLem SA.
Recruitment status was: Active, not recruiting
First Posted : July 9, 2012
Last Update Posted : January 27, 2015
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
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||1500 participants|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||March 2016|
|Patients treated with Esmya|
- Occurrence of SAEs, adverse events (AEs) considered to be related to ESMYA or AEs leading to ESMYA treatment discontinuation. [ Time Frame: Patients will be followed from baseline up to 15 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635452
Show 75 Study Locations
|Study Director:||Jaime Oliver, MD||PregLem SA|