Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01087593
• Other study ID #: 151 662/01
• Status: Terminated
• Phase: N/A
• First received: March 15, 2010
• Last updated: March 15, 2010
• Start date: August 2001
• Est. completion date: October 2007

Study information

• Verified date: September 2001
• Source: Ostergotland County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• 17ß-estradiol
Transdermal administration(50 ug daily)for a period of ten weeks with additional treatment of medroxyprogesterone (10mg daily) for the last two weeks

Locations

Country	Name	City	State
Sweden	University hospital in Linköping	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Ostergotland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain thresholds and pain tolerance		Before and after eight weeks treatment	No