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临床试验/NCT01087593
NCT01087593终止不适用

Hormonal Replacement Therapy Does Not Affect Self-estimated Pain or Experimental Pain Responses in Postmenopausal Women Suffering From Fibromyalgia: A Double-blind, Randomized, Placebo-controlled Trial

Ostergotland County Council, Sweden1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2001年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
发起方
入组人数
29
试验地点
1
主要终点
Pain thresholds and pain tolerance

研究概览

简要总结

In order to evaluate the potential effects of estrogen treatment in postmenopausal women with fibromyalgia, the investigators used quantitative sensory tests before and after eight weeks of estrogen treatment as compared with placebo treatment.

详细描述

Fibromyalgia is a condition that preferentially affects women. Sex hormones, and in particular estrogens, have been shown to affect pain processing and pain sensitivity, and estrogen deficit has been considered a potential promoting factor for fibromyalgia. However, the effects of estrogen treatment in patients suffering from fibromyalgia have not been studied. Twenty-nine postmenopausal women were randomized to either eight weeks of treatment with transdermal 17β-estradiol (50 ug daily) or placebo according to a double-blind protocol. A self-estimation of pain, a set of quantitative sensory tests measuring thresholds to temperature, thermal pain, cold pain and pressure pain, and a cold pressor test were performed at three occasions: before treatment, after eight weeks of treatment, and twenty weeks after cessation of treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Between 49-60 years
  • Body mass index (BMI) of < 30
  • Met the ACR-90 criteria for the diagnosis of fibromyalgia
  • Postmenopausal state since at least six months
  • Not been using any hormonal treatments for the past three months
  • Had normal mammography screenings

排除标准

  • Using psychotropic drugs or having a history of thromboembolism
  • Diabetes mellitus, polyneuropathy, chronic liver disease,
  • Alcohol or substance abuse, hemoglobinopathy,
  • Endometrial adenomatous hyperplasia, or malignancy.
  • Presence of untreated hypertension (>160/95).
  • Undiagnosed vaginal bleedings

研究组 & 干预措施

Treatment with transdermal 17β-estradiol

Experimental

干预措施: 17β-estradiol (Drug)

Control

Placebo Comparator

干预措施: 17β-estradiol (Drug)

结局指标

主要结局

Pain thresholds and pain tolerance

时间窗: Before and after eight weeks treatment

次要结局

未报告次要终点

研究者

发起方
Ostergotland County Council, Sweden
申办方类型
Other

研究点 (1)

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