Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT02748460
Eligibility Criteria:
Inclusion Criteria:
* Adult women of reproductive age with a diagnosis of moderate to severe symptoms of uterine fibroids who are not eligible for surgery and for whom a intermittent 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 has a contraindication to receive Esmya as per SmPC
* 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02748460
Study Brief:
Protocol Section:
NCT02748460