MedTrace Logo

The Effect of Ulipristal Acetate (UPA) on Women Ovarian Reserve

NCT02361892 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2016-11-18

No results posted yet for this study

Summary

The uterine leiomyoma is the most common female benign disease.UPA seems to be most effective for the medical management of fibroids and could be place as preoperative adjunct to surgery but also as medical therapy to avoid surgery. No data have been published about the effect of UPA on FSH (Follicle stimulating hormone) or AMH levels nor on ovarian antral follicle count (AFC) or vascularization indexes during and after treatment. Considering that in young women of reproductive age (under 40 years old), desiring pregnancy, UPA has been proposed to avoid or postpone surgery, also in a long-term administration program, data about its effect on women ovarian reserve are urgently needed.

For these reasons, data on biochemical (AMH, FSH and E2) and 3D ultrasonographic (VI, Flow index, AFC) parameters of women treated by UP are needed to assess the effect of the drug in terms of ovarian reserve modification.

Conditions

Interventions

DRUG

ulipristal acetate

5 mg/day will be administered starting from day 1 of the cycle for two courses of 3 months each

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
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-06-30
Completion
2017-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT02361892 on ClinicalTrials.gov