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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

NCT01635452 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2015-01-27

No results posted yet for this study

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

  • Uterine Fibroids

Sponsors & Collaborators

  • PregLem SA

    lead INDUSTRY

Principal Investigators

  • Jaime Oliver, MD · PregLem SA

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-04-30
Completion
2016-03-31

Countries

  • Austria
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Portugal
  • Romania
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01635452 on ClinicalTrials.gov