Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia

Not Applicable

Terminated

• Conditions: Fibromyalgia
• Interventions: Drug: 17β-estradiol

• Registration Number: NCT01087593
• Lead Sponsor: Ostergotland County Council, Sweden

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2001-08
• Status Verified: 2001-09
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-15
• Last Update Submitted: 2010-03-15
• Study First Posted: 2010-03-16
• Last Update Posted: 2010-03-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with transdermal 17β-estradiol	17β-estradiol	-
Control	17β-estradiol	-

Primary Outcome Measures

Name	Time	Method
Pain thresholds and pain tolerance	Before and after eight weeks treatment

Trial Locations

Locations (1)

University hospital in Linköping; 🇸🇪 Linköping, Sweden