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

NCT02361892 | Unknown Phase 4 DMC

• 1 other identifier: UPA and ovarian reserve
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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

Infertility

Keywords

ovarian reserve; infertility; leiomyomas; ulipristal acetate

Outcome Measures

Primary Outcomes (1)

• Ovarian age change after two courses of UPA

  Ovarian Age will be assessed as a composite outcome by measuring FSH, Estradiol, AMH, 3D-AFC, VI, FI and VFI (vascularization flow index) in the follicular phase of the menstrual cycle before the start of treatment. The assessment will be repeated during the fifth month of UPA assumption. change will be quantified

  In the follicular phase of the month before treatment and during the fifth month of treatment

Study Arms (1)

Ulipristal acetate

EXPERIMENTAL

Women will be treated with 5mg/die of Ulipristal acetate for 2 courses of 3 months each

Drug: ulipristal acetate

Interventions

ulipristal acetate DRUG

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

Also known as: Esmya

Ulipristal acetate

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• submucosal,
• intramural or subserosal leiomyomas,
• symptoms of menometrorrhagia,
• menstrual disorder,
• infertility,
• pelvic pain

You may not qualify if:

• endometrial hyperplasia with atypia,
• estrogen-progestin therapy in the 2 months before enrollment,
• autoimmune diseases,
• chronic, metabolic, systemic and endocrine disorders, including hyperandrogenism, hyperprolactinemia, diabetes mellitus and thyroid disease,
• hypogonadotropic hypogonadism,
• majors clinical conditions

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

Azienda Ospedaliera Pugliese-Ciaccio

Catanzaro, Catanzaro, 88100, Italy

RECRUITING

MeSH Terms

Conditions

Infertility; Leiomyoma

Interventions

ulipristal acetate

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Fulvio Zullo, MD,PhD

  Magna Graecia University of Catanzaro

  STUDY DIRECTOR

• Roberta Venturella, MD

  Magna Graecia University of Catanzaro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fulvio Zullo, MD,PhD

CONTACT

00390961883234; zullo@unicz.it

Roberta Venturella, MD

CONTACT

00390961883401; rovefa@libero.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 12, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

IT (1)