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Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting

NCT02748460 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1527

Last updated 2025-09-02

No results posted yet for this study

Summary

This is a multi-centre, multinational, prospective, non-interventional study in females with a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and in subjects who were previously exposed to UPA in the long term Phase III studies.

Conditions

  • Uterine Fibroids

Sponsors & Collaborators

  • PregLem SA

    lead INDUSTRY

Principal Investigators

  • Pablo Arriagada · PregLem SA

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-22
Primary Completion
2024-04-11
Completion
2024-04-11

Countries

  • Belgium
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden
  • 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 NCT02748460 on ClinicalTrials.gov