This trial is active, not recruiting.

Condition uterine fibroids
Sponsor PregLem SA
Start date May 2012
End date April 2014
Trial size 1500 participants
Trial identifier NCT01635452, PGL10-014


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

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

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Pre-menopausal adult women with a diagnosis of moderate or severe symptoms of uterine fibroids who are initiating treatment with ESMYA. Exclusion Criteria: - Patient is pregnant or plans to become pregnant in the next 3 months, - Patient is breastfeeding, - Patient has genital bleeding of unknown etiology or not due to uterine fibroids, - Patient has been diagnosed with uterine, cervical, ovarian or breast cancer, - Patient is using an investigational drug/therapy or has discontinued the use of an investigational drug/therapy within 30 days prior to study enrollment, - Patient has hypersensitivity to the active substance of ESMYA or to one of its excipients

Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by PregLem SA.