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临床试验/NCT02449161
NCT02449161终止3 期

The Effect of Post Ablation Medroxyprogesterone Acetate on Endometrial Amenorrhea Rates: a RCT

Guy Waddell1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
发起方
Guy Waddell
入组人数
60
试验地点
1
主要终点
quantification of amenorrhea

研究概览

简要总结

Heavy menstrual bleeding are a common reason for consultation in gynecology and are defined by International Federation of Gynecology and Obstetrics as the perception of menstrual volume increased regardless of the frequency, duration and regularity. Some studies report that up to 30% of women will suffer from heavy periods during their lifetime. The first line treatment of heavy bleeding is medical. However, a significant proportion of women require surgery. Until the 80s, hysterectomy was one of the only surgical options and often performed as the first line treatment. Since twenty years now the endometrial ablation has become a preferred option for dysfunctional uterine bleeding and avoids hysterectomy in a significant proportion of patients suffering from this type of problem. Endometrial ablation is much less invasive and morbid than hysterectomy, however, many patients do not achieve a complete amenorrhea with endometrial ablation and about 15% may have to require a new intervention, such as hysterectomy, following the persistence of menstrual problems. A Cochrane review published in 2013 showed that the satisfaction rate following endometrial ablation is high at 70-80% and about 35% of women have amenorrhea. The complete destruction of the endometrium is the most important predictor of the success of the procedure. Studies have shown that better results are obtained when the surgery is performed when the endometrium is thin or immediately following menses or following administration of a hormonal agent causes atrophy of the endometrium. One of the agents studied to prepare the endometrium before ablation is medroxyprogesterone acetate (MPA) as injectables (DMPA) and oral. Progestins have an antiproliferative effect on the endometrium. In recent years, numerous studies have examined the use of various agents preoperatively, including MPA and DMPA to facilitate surgery by reducing the thickness of the endometrium. However, few studies have focused on the conditions of the post-operative period to promote the therapeutic response to the intervention. The investigators hypothesis is whether the MPA administered in immediate post-operative would inhibit proliferation of endometrial cells responsible for the persistence of menstruation and optimize the clinical response to endometrial ablation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • endometrial ablation planned for eavy menstrual bleeding
  • No abnormalities at hysteroscopy
  • No evidence of hyperplasia or neoplasia in endometrial biopsy
  • Hysterometry of ≤ 10 cm preoperatively

排除标准

  • Any indication against MPA
  • Intrauterine pathology causing heavy bleeding
  • hormonal treatment provided during the postoperative period (during the first 4 months)
  • preoperative hormonal therapy with a residual postoperative effect
  • breastfeeding
  • future pregnancy planned
  • menopausal women
  • endometrial ablation antecedent
  • Suspected pelvic infection
  • known Hematologic Disease
  • Taking anticoagulant
  • Taking progestin in the 6 months before surgery

研究组 & 干预措施

MPA

Experimental

medroxyprogesterone acetate, 10 mg/day, for 90 days, following endometrial ablation

干预措施: MPA (Drug)

placebo

Placebo Comparator

1 placebo/day, for 90 days, following endometrial ablation

干预措施: placebo (Drug)

结局指标

主要结局

quantification of amenorrhea

时间窗: 12 months

using the "Pictorial Blood Loss Assessment Chart" for quantification

次要结局

  • documentation of side effects(4 months)
  • quantification of amenorrhea(4 months)

研究者

发起方
Guy Waddell
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Guy Waddell

MD

Université de Sherbrooke

研究点 (1)

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