Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia

NCT ID: NCT01087593

Last Updated: 2010-03-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31
• Study Completion Date: 2007-10-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment with transdermal 17β-estradiol

Group Type: EXPERIMENTAL

17β-estradiol

Intervention Type: DRUG

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

Control

Group Type: PLACEBO_COMPARATOR

17β-estradiol

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Evorel; provera

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ostergotland County Council, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Ostergotland County Council

Principal Investigators

Mats Hammar, MD, prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Linkoeping

Locations

University hospital in Linköping

Linköping, , Sweden

Countries

Sweden

References

Stening KD, Eriksson O, Henriksson KG, Brynhildsen J, Lindh-Astrand L, Berg G, Hammar M, Amandusson A, Blomqvist A. Hormonal replacement therapy does not affect self-estimated pain or experimental pain responses in post-menopausal women suffering from fibromyalgia: a double-blind, randomized, placebo-controlled trial. Rheumatology (Oxford). 2011 Mar;50(3):544-51. doi: 10.1093/rheumatology/keq348. Epub 2010 Nov 14.

Reference Type: DERIVED

PMID: 21078629 (View on PubMed)

Other Identifiers

151 662/01

Identifier Type: -

Identifier Source: org_study_id