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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)

This study is currently recruiting participants.
Verified April 2013 by PregLem SA
Sponsor:
Information provided by (Responsible Party):
PregLem SA
ClinicalTrials.gov Identifier:
NCT01635452
First received: June 26, 2012
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Uterine Fibroids

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Further study details as provided by PregLem SA:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1500
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients treated with Esmya

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The target study population will include women who have had a diagnosis of symptomatic uterine fibroids and are initiating preoperative treatment with ESMYA.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01635452

Contacts
Contact: Simeon Ocran simeon.ocran@preglem.com

  Show 75 Study Locations
Sponsors and Collaborators
PregLem SA
Investigators
Study Director: Jaime Oliver, MD PregLem SA
  More Information

No publications provided

Responsible Party: PregLem SA
ClinicalTrials.gov Identifier: NCT01635452     History of Changes
Other Study ID Numbers: PGL10-014
Study First Received: June 26, 2012
Last Updated: April 29, 2013
Health Authority: Germany: Ethics Commission
Spain: Ethics Committee
France: Institutional Ethical Committee
Italy: Ethics Committee
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 19, 2013