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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
Ostergotland County Council, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

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

40 Years - 60 Years (Adult)FemaleDoes not accept 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

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

First Posted
March 15, 2010
Last Updated
March 15, 2010
Sponsor
Ostergotland County Council, Sweden
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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

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Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia

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