Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
17β-estradiol
Sponsored by
About this trial
This is an interventional basic science trial for Fibromyalgia focused on measuring estrogen, substitution, pain, hormonal levels, quantitative sensory testing
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
Sites / Locations
- University hospital in Linköping
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment with transdermal 17β-estradiol
Control
Arm Description
Outcomes
Primary Outcome Measures
Pain thresholds and pain tolerance
Secondary Outcome Measures
Full Information
NCT ID
NCT01087593
First Posted
March 15, 2010
Last Updated
March 15, 2010
Sponsor
Ostergotland County Council, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT01087593
Brief Title
Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia
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 Type
Interventional
2. Study Status
Record Verification Date
September 2001
Overall Recruitment Status
Terminated
Why Stopped
Due to ethical concerns regard to the results from the WHI study
Study Start Date
August 2001 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ostergotland County Council, Sweden
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
estrogen, substitution, pain, hormonal levels, quantitative sensory testing
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with transdermal 17β-estradiol
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
17β-estradiol
Other Intervention Name(s)
Evorel, provera
Intervention Description
Transdermal administration(50 ug daily)for a period of ten weeks with additional treatment of medroxyprogesterone (10mg daily) for the last two weeks
Primary Outcome Measure Information:
Title
Pain thresholds and pain tolerance
Time Frame
Before and after eight weeks treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mats Hammar, MD, prof
Organizational Affiliation
University Hospital, Linkoeping
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital in Linköping
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
21078629
Citation
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.
Results Reference
derived
Learn more about this trial
Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia
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