CompletedNot Applicable

Observation of Long-term Effects on Endometrium and Uterine Fibroids in Women With Ulipristal Acetate Therapy

Italy89 participantsStarted 2018-11-01

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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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

What they're measuring

Dysmenhorrea (VAS score)

Timeframe: 12 months

Endometrial thickess (mm)

Timeframe: 12 months

Myoma's diameter (mm)

Timeframe: 12 months

Trial details

NCT IDNCT03972917

SponsorUniversity of Campania Luigi Vanvitelli

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-07-10

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