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Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia

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ClinicalTrials.gov Identifier: NCT01087593
Recruitment Status : Terminated (Due to ethical concerns regard to the results from the WHI study)
First Posted : March 16, 2010
Last Update Posted : March 16, 2010
Sponsor:
Information provided by:
Ostergotland County Council, Sweden

Tracking Information
First Submitted Date  ICMJE March 15, 2010
First Posted Date  ICMJE March 16, 2010
Last Update Posted Date March 16, 2010
Study Start Date  ICMJE August 2001
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2010)
Pain thresholds and pain tolerance [ Time Frame: Before and after eight weeks treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Fibromyalgia
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Treatment with transdermal 17β-estradiol
    Intervention: Drug: 17β-estradiol
  • Placebo Comparator: Control
    Intervention: Drug: 17β-estradiol
Publications * Stening KD, Eriksson O, Henriksson KG, Brynhildsen J, Lindh-Åstrand 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 15, 2010)
29
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01087593
Other Study ID Numbers  ICMJE 151 662/01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mats Hammar, Ostergotland County Council
Study Sponsor  ICMJE Ostergotland County Council, Sweden
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mats Hammar, MD, prof University Hospital, Linkoeping
PRS Account Ostergotland County Council, Sweden
Verification Date September 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP