Uterine Fibroids
Conditions
Brief summary
This is a multi-center, prospective, non-interventional study of patients who have been diagnosed with moderate to severe symptoms of uterine fibroids and are initiating a pre-operative treatment with ESMYA. The objectives of the study are to characterize and describe treatment with ESMYA and to evaluate the safety, effectiveness, and HRQL outcomes in this population
Interventions
None listed
Sponsors
PregLem SA
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Pre-menopausal adult women with a diagnosis of moderate or severe symptoms of uterine fibroids who are initiating treatment with ESMYA.
Exclusion criteria
* Patient is pregnant or plans to become pregnant in the next 3 months, * Patient is breastfeeding, * Patient has genital bleeding of unknown etiology or not due to uterine fibroids, * Patient has been diagnosed with uterine, cervical, ovarian or breast cancer, * Patient is using an investigational drug/therapy or has discontinued the use of an investigational drug/therapy within 30 days prior to study enrollment, * Patient has hypersensitivity to the active substance of ESMYA or to one of its excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of SAEs, adverse events (AEs) considered to be related to ESMYA or AEs leading to ESMYA treatment discontinuation. | Patients will be followed from baseline up to 15 months |
Countries
Austria, France, Germany, Hungary, Italy, Poland, Portugal, Romania, Spain, United Kingdom
Outcome results
None listed