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

• Conditions: Uterine Fibroids

• Registration Number: NCT01635452
• Lead Sponsor: PregLem SA

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-07-03
• Study First Posted: 2012-07-09
• Primary Completion: 2014-04
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-01-27
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of SAEs, adverse events (AEs) considered to be related to ESMYA or AEs leading to ESMYA treatment discontinuation.	Patients will be followed from baseline up to 15 months

Trial Locations

Locations (61)

LKH Klagenfurt; 🇦🇹 Klagenfurt, Austria

Private practice; 🇵🇱 Lublin, Poland

CHU Pellegrin Gynécologie; 🇫🇷 Bordeaux, France

Hopital Bicetre; 🇫🇷 Le Kremlin-Bicètre, France

CHU La Conception; 🇫🇷 Marseille, France

CHU Hôpital Mère-enfant; 🇫🇷 Nantes, France

Tenon CHU Paris Est; 🇫🇷 Paris, France

CHUV Maison Blanche Institut; 🇫🇷 Reims, France

CHU Anne de Bretagne; 🇫🇷 Rennes, France

CHU Tours Gynécologie; 🇫🇷 Tours, France

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