Trial | NCT01087593  Report issue

Title

Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia
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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    estradiol ...

  • Study Participants

    29
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.
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.
Study Started
Aug 31
2001
Primary Completion
Oct 31
2007
Study Completion
Oct 31
2007
Last Update
Mar 16
2010
Estimate

Drug 17β-estradiol

Transdermal administration(50 ug daily)for a period of ten weeks with additional treatment of medroxyprogesterone (10mg daily) for the last two weeks

  • Other names: Evorel, provera

Treatment with transdermal 17β-estradiol Experimental

Control Placebo Comparator

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted