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

NCT ID: NCT02361892

Last Updated: 2016-11-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-09-30

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.

Detailed Description

The uterine leiomyoma is the most common benign tumor of the female genital tract. The myomas are usually clinically apparent in 25% of patients. Among the latest possible therapeutic options, UPA has proved to be most effective for the medical management of fibroids. Its advent in the clinical practice will probably modify the surgical approach, since UPA could possible place as a preoperative adjunct to surgery but also as medical therapy to avoid surgery. Very recently, the results of the first study on long-term intermittent (18 months) therapy with 10-mg UPA were published, demonstrating that this regimen (four courses of 3 months) maximizes the effect of UPA by inducing a very high rate of amenorrhea and reducing fibroid size.

Long term treatment, however, call in question safety issue that need to be explore. In patients treated by UPA, Estradiol under 5-mg and 10-mg doses remained at midfollicular levels after the first course of therapy, avoiding menopausal symptoms, as frequently observed in the gonadotropin-releasing hormone (GnRH-) agonist group. No data have been published about Estradiol levels at the end of second, third and fourth courses of UPA. Moreover, no data have been published about the effect of UPA on FSH 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, FI, 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ulipristal acetate

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

Group Type: EXPERIMENTAL

ulipristal acetate

Intervention Type: DRUG

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

Interventions

ulipristal acetate

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

Intervention Type: DRUG

Other Intervention Names

Esmya

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Magna Graecia

OTHER

Sponsor Role: lead

Responsible Party

Fulvio Zullo

Full professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fulvio Zullo, MD,PhD

Role: STUDY_DIRECTOR

Magna Graecia University of Catanzaro

Roberta Venturella, MD

Role: PRINCIPAL_INVESTIGATOR

Magna Graecia University of Catanzaro

Locations

Azienda Ospedaliera Pugliese-Ciaccio

Catanzaro, Catanzaro, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Fulvio Zullo, MD,PhD

Role: CONTACT

Phone: 00390961883234

Email: zullo@unicz.it

Roberta Venturella, MD

Role: CONTACT

Phone: 00390961883401

Email: rovefa@libero.it

Facility Contacts

Fulvio Zullo

Role: primary

Other Identifiers

UPA and ovarian reserve

Identifier Type: -

Identifier Source: org_study_id