Observation of Long-term Effects on Endometrium and Uterine Fibroids in Women With Ulipristal Acetate Therapy
Completed
- Conditions
- Uterine Bleeding, DysfunctionalEndometrium HyperplasiaUterine Bleeding HeavyDysmenorrheaMyoma
- Interventions
- Diagnostic Test: Transvaginal ultrasonographic examination
- Registration Number
- NCT03972917
- Lead Sponsor
- University of Campania "Luigi Vanvitelli"
- Brief Summary
A prospective observational study on italian women undergoing ulipristal acetate (uPa) therapy for symptomatic myomas and its impact on symptomatology and moreover on myomas architecture. We also evaluate changes in the endometrial pattern of selected women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 89
Inclusion Criteria
- number of myomas from 1 to 4
- heavy menstrual bleeding
- conservative treatment request
Exclusion Criteria
- concurrent endometrial pathology
- post-menopausal status
- hepatic pathology
- endocrine or metabolic disorders
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ulipristal acetate based therapy Transvaginal ultrasonographic examination Fertile women under ulipristal acetate treatment
- Primary Outcome Measures
Name Time Method Endometrial thickess (mm) 12 months Myoma's diameter (mm) 12 months Dysmenhorrea (VAS score) 12 months
- Secondary Outcome Measures
Name Time Method Live birth rate (LBR) 12 months Live birth rate if women conceived spontaneously or through ARTs after treatment
Trial Locations
- Locations (1)
Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"
🇮🇹Naples, Italy