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Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia

Sponsor
Ostergotland County Council, Sweden (Other)
Overall Status
Terminated
CT.gov ID
NCT01087593
Collaborator
(none)
29
Enrollment
1
Location
2
Arms
74
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
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
Study Start Date :
Aug 1, 2001
Actual Primary Completion Date :
Oct 1, 2007
Actual Study Completion Date :
Oct 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment with transdermal 17β-estradiol

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

    		•
    Placebo Comparator: Control

    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain thresholds and pain tolerance [Before and after eight weeks treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University hospital in Linköping Linköping Sweden 581 85

    Sponsors and Collaborators

    • Ostergotland County Council, Sweden

    Investigators

    • Principal Investigator: Mats Hammar, MD, prof, University Hospital, Linkoeping

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01087593
    Other Study ID Numbers:
    • 151 662/01
    First Posted:
    Mar 16, 2010
    Last Update Posted:
    Mar 16, 2010
    Last Verified:
    Sep 1, 2001
    Keywords provided by , ,
    estrogen
    substitution
    pain
    hormonal levels
    quantitative sensory testing
    Additional relevant MeSH terms:
    Fibromyalgia
    Myofascial Pain Syndromes
    Estradiol 17 beta-cypionate
    Estradiol 3-benzoate
    Estradiol
    Polyestradiol phosphate

    Study Results

    No Results Posted as of Mar 16, 2010