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

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ClinicalTrials.gov Identifier: NCT02361892
Recruitment Status : Unknown
Verified November 2016 by Fulvio Zullo, University Magna Graecia.
Recruitment status was:  Recruiting
First Posted : February 12, 2015
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Fulvio Zullo, University Magna Graecia

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.


Condition or disease Intervention/treatment Phase
Infertility Drug: ulipristal acetate Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of UPA on Women Ovarian Reserve
Study Start Date : February 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Ulipristal acetate
Women will be treated with 5mg/die of Ulipristal acetate for 2 courses of 3 months each
Drug: ulipristal acetate
5 mg/day will be administered starting from day 1 of the cycle for two courses of 3 months each
Other Name: Esmya




Primary Outcome Measures :
  1. Ovarian age change after two courses of UPA [ Time Frame: In the follicular phase of the month before treatment and during the fifth month of treatment ]
    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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361892


Contacts
Contact: Fulvio Zullo, MD,PhD 00390961883234 zullo@unicz.it
Contact: Roberta Venturella, MD 00390961883401 rovefa@libero.it

Locations
Italy
Azienda Ospedaliera Pugliese-Ciaccio Recruiting
Catanzaro, Italy, 88100
Contact: Fulvio Zullo    00390961883234    zullo@unicz.it   
Sponsors and Collaborators
University Magna Graecia
Investigators
Study Director: Fulvio Zullo, MD,PhD Magna Graecia University of Catanzaro
Principal Investigator: Roberta Venturella, MD Magna Graecia University of Catanzaro

Responsible Party: Fulvio Zullo, Full professor, University Magna Graecia
ClinicalTrials.gov Identifier: NCT02361892     History of Changes
Other Study ID Numbers: UPA and ovarian reserve
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Fulvio Zullo, University Magna Graecia:
ovarian reserve
infertility
leiomyomas
ulipristal acetate

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female