Clinical trial · Observational
Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting
Prospective, Multi-national, Multicentre, Non-interventional Study to Evaluate the Long Term Safety of Esmya, in Particular Endometrial Safety, and the Current Prescription and Management Patterns of Esmya in a Long Term Treatment Setting.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients treated with Esmya
- description
- Any patient who was confirmed as receiving one dose of Esmya
Primary outcomes (1)
- measure
- Assessment of long term safety: Occurrence of gynaecological AEs, SAEs, non-serious ADRs, AEs leading to ESMYA treatment discontinuation
- timeFrame
- Patients will be followed from baseline up to 60 months
- description
- Occurrence of gynaecological AEs, SAEs, non-serious ADRs, AEs leading to ESMYA treatment discontinuation
Secondary outcomes (1)
- measure
- Assessment of Prescription pattern of Esmya in standard medical practice
- timeFrame
- Patients will be followed from baseline up to 60 months
- description
- Esmya use in patients
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available