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

Infertility Clinical Trial

— UPA_ovAge  

Official title:

The Effect of UPA on Women Ovarian Reserve

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02361892
• Other study ID #: UPA and ovarian reserve
• Status: Recruiting
• Phase: Phase 4
• First received: February 2, 2015
• Last updated: November 17, 2016
• Start date: February 2015
• Est. completion date: September 2017

Study information

• Verified date: November 2016
• Source: University Magna Graecia
• Contact: Fulvio Zullo, MD,PhD
• Phone: 00390961883234
• Email: zullo[@]unicz.it
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 73
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• ulipristal acetate
5 mg/day will be administered starting from day 1 of the cycle for two courses of 3 months each

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Pugliese-Ciaccio	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes