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临床试验/NCT02361892
NCT02361892Unknown4 期

The Effect of UPA on Women Ovarian Reserve

University Magna Graecia1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
73
试验地点
1
主要终点
Ovarian age change after two courses of UPA

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Ulipristal acetate

Experimental

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

干预措施: ulipristal acetate (Drug)

结局指标

主要结局

Ovarian age change after two courses of UPA

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
University Magna Graecia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fulvio Zullo

Full professor

University Magna Graecia

研究点 (1)

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