Dysmenorrhea Clinical Trial
Official title:
Long-term Observation of Symptomatic Women With Uterine Fibroids Who Have Been Treated With Ulipristal Acetate: Findings on Symptomatology, Morphological Structure, Endometrial Patterns
NCT number | NCT03972917 |
Other study ID # | N.595 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2018 |
Est. completion date | September 21, 2021 |
Verified date | January 2023 |
Source | University of Campania "Luigi Vanvitelli" |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 89 |
Est. completion date | September 21, 2021 |
Est. primary completion date | July 10, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli" | Naples |
Lead Sponsor | Collaborator |
---|---|
University of Campania "Luigi Vanvitelli" |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dysmenhorrea (VAS score) | 12 months | ||
Primary | Endometrial thickess (mm) | 12 months | ||
Primary | Myoma's diameter (mm) | 12 months | ||
Secondary | Live birth rate (LBR) | Live birth rate if women conceived spontaneously or through ARTs after treatment | 12 months |
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