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

• Sponsor: University of Campania "Luigi Vanvitelli" (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03972917
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myoma; Uterine Bleeding, Dysfunctional; Uterine Bleeding Heavy; Dysmenorrhea; Endometrium Hyperplasia	Diagnostic Test: Transvaginal ultrasonographic examination

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Nov 1, 2018
• Anticipated Primary Completion Date: Nov 1, 2021
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
ulipristal acetate based therapy Fertile women under ulipristal acetate treatment	Diagnostic Test: Transvaginal ultrasonographic examination; Evaluation of endometrial thickness; myoma size and volume

Outcome Measures

Primary Outcome Measures

1. Dysmenhorrea (VAS score) [12 months]

2. Endometrial thickess (mm) [12 months]

3. Myoma's diameter (mm) [12 months]

Secondary Outcome Measures

1. Live birth rate (LBR) [12 months]

   Live birth rate if women conceived spontaneously or through ARTs after treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"	Naples		Italy

Sponsors and Collaborators

• University of Campania "Luigi Vanvitelli"

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Pasquale De Franciscis, Associate Professor, University of Campania "Luigi Vanvitelli"
• ClinicalTrials.gov Identifier: NCT03972917
• Other Study ID Numbers: N.595
• First Posted: Jun 4, 2019
• Last Update Posted: Jun 23, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Prof. Pasquale De Franciscis, Associate Professor, University of Campania "Luigi Vanvitelli": ulipristal acetate; myoma; leiomyoma; endometrial patterns; symptomatology
• Additional relevant MeSH terms: Leiomyoma; Myofibroma; Uterine Hemorrhage; Metrorrhagia; Endometrial Hyperplasia; Hemorrhage; Hyperplasia; Dysmenorrhea

Study Results

No Results Posted as of Jun 23, 2020