Observation of Long-term Effects on Endometrium and Uterine Fibroids in Women With Ulipristal Acetate Therapy
Completed
- Conditions
- Uterine Bleeding, DysfunctionalEndometrium HyperplasiaUterine Bleeding HeavyDysmenorrheaMyoma
- 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
- 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms explain ulipristal acetate's effects on uterine fibroid architecture and endometrial patterns in NCT03972917?
How does ulipristal acetate compare to GnRH agonists in managing heavy menstrual bleeding from fibroids?
Which biomarkers correlate with sustained symptom relief in women treated with ulipristal acetate for myomas?
What are the long-term safety concerns of selective progesterone receptor modulators like ulipristal acetate in fibroid therapy?
How do uterine fibroid regression patterns in NCT03972917 relate to other SERM-based treatments like raloxifene or asoprisnil?
Trial Locations
- Locations (1)
Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"
🇮🇹Naples, Italy
Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"🇮🇹Naples, Italy