A Prospective Multicenter Non-interventional Study of Women Treated With ESMYA (Ulipristal Acetate) as Pre-operative Treatment of Moderate to Severe Symptoms of Uterine Fibroids (PREMYA)

PregLem

Status: Unknown

Conditions: Uterine Fibroids

Study type: Observational

Funder types: Industry

Identifiers

NCT01635452

PGL10-014

Details and patient eligibility

About

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

Enrollment: 1,500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,500 participants in 1 patient group

Patients treated with Esmya