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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02748460
• Date of registration: 19/04/2016
• Prospective Registration: No
• Primary sponsor: PregLem SA
• Public title: Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting Premium
• Scientific title: 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.
• Date of first enrolment: December 2015
• Target sample size: 1500
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02748460
• Study type: Observational

Countries of recruitment

Belgium, Czech Republic, Czechia, Denmark, France, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Spain, Sweden, United Kingdom

Contacts

• Name: Pablo Arriagada
• Affiliation: PregLem SA

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Uterine Fibroids

Primary Outcome(s)

Assessment of long term safety: Occurrence of gynaecological AEs, SAEs, non-serious ADRs, AEs leading to ESMYA treatment discontinuation [Time Frame: Patients will be followed from baseline up to 60 months]

Secondary Outcome(s)

Assessment of Prescription pattern of Esmya in standard medical practice [Time Frame: Patients will be followed from baseline up to 60 months]

Secondary ID(s)

PGL14-001 (PREMIUM)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors