Last updated on February 2018

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: UTERINE FIBROID
  • Age: Between 18 - 100 Years
  • Gender: Female

Inclusion Criteria:

  • Adult women of reproductive age with a diagnosis of moderate to severe symptoms of uterine fibroids for whom a treatment with Esmya in a long term manner (at least 2 courses), is planned or subjects who were exposed to UPA 5 or 10 mg during long term Phase III trials PGL09-027 (PEARL III extension, including patients (PEARL extension 2)) or PGL11-006 (PEARL IV), and
  • Patient is willing and able to attend visits which are scheduled by her treating physician for the regular follow-up, provide the required medical data, and
  • Patient has personally signed and dated the informed consent document indicating that she has been informed of all pertinent aspects of the study.

Exclusion criteria:

  • Patient is prescribed Esmya for pre-operative treatment
  • Patient is using an investigational drug/therapy or has discontinued the use of an investigational drug/therapy within 30 days prior to study enrolment,
  • Patient has hypersensitivity to the active substance of Esmya or to one of its excipients,
  • Not applicable to long term phase III previous subjects who are not planning to receive Esmya during this study:
  • Patient is pregnant or plans to become pregnant within the next 12 months from treatment start,
  • Patient is breastfeeding,
  • Patient has genital bleeding of unknown aetiology or not due to uterine fibroids,
  • Patient has been diagnosed with uterine, cervical, ovarian or breast cancer.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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