The Effect of Ulipristal Acetate (UPA) on Women Ovarian Reserve
Information source: University Magna Graecia
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: ulipristal acetate (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Magna Graecia Official(s) and/or principal investigator(s): Fulvio Zullo, MD,PhD, Principal Investigator, Affiliation: Magna Graecia University of Catanzaro
Overall contact: Fulvio Zullo, MD,PhD, Phone: 00390961883234, Email: zullo@unicz.it
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.
Clinical Details
Official title: The Effect of UPA on Women Ovarian Reserve
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Ovarian age change after two courses of UPA
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
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
Locations and Contacts
Fulvio Zullo, MD,PhD, Phone: 00390961883234, Email: zullo@unicz.it
Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro 88100, Italy; Recruiting Fulvio Zullo, Phone: 00390961883234, Email: zullo@unicz.it
Additional Information
Starting date: February 2015
Last updated: February 8, 2015
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