Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia

Ostergotland County Council, Sweden

Status: Terminated

Conditions: Fibromyalgia

Treatments: Drug: 17β-estradiol

Study type: Interventional

Funder types: Other

Identifiers

NCT01087593

151 662/01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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29 participants in 2 patient groups, including a placebo group

Treatment with transdermal 17β-estradiol

Experimental group

Treatment:

Drug: 17β-estradiol

Control

Placebo Comparator group

Treatment:

Drug: 17β-estradiol