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Ulipristal Acetate Versus GnRH Analogue and Myometrial Preservation

NCT02357563 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2016-11-18

No results posted yet for this study

Summary

Submucosal fibroid grow inside the uterine cavity and are associated with menorrhagia, abnormal uterine bleeding (AUB) and infertility. Type II (G2) fibroids often require more surgeries due to their particular position in the myometrium. Surgery, moreover, should always be tailored, particularly in patients wishing to conceive, to preserve the integrity of the myometrium. Preoperative use of GnRH agonist appears to be relevant and beneficial in patients with submucous fibroids, but are associated with several side effects. the eighty percent of patients treated by UPA showed a clinically meaningful reduction of more than 25% in fibroid volume, and 50% of patients a reduction of 50%. fibroid volume reduction appeared to be maintained for 6 months after the end of UPA treatment

Conditions

  • Fibroid

Interventions

DRUG

ulipristal acetate

5 mg/day will be administered starting from day 1 of the cycle and up to three months later for two courses, with an interval between the courses of 1 month

DRUG

Leuprolide acetate

One dose of 11.25 GnRH analogue depot will be administered in the luteal phase of the menstrual cycle (days 21-24) and repeated 3 months later

Sponsors & Collaborators

  • University Magna Graecia

    lead OTHER

Principal Investigators

  • Fulvio Zullo, MD,PhD · Magna Graecia University of Catanzaro

  • Roberta Venturella, MD · Magna Graecia University of Catanzaro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02357563 on ClinicalTrials.gov