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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

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
Fibromyalgia Drug: 17β-estradiol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : August 2001
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007


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




Primary Outcome Measures :
  1. Pain thresholds and pain tolerance [ Time Frame: Before and after eight weeks treatment ]


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087593


Locations
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Sweden
University hospital in Linköping
Linköping, Sweden, 581 85
Sponsors and Collaborators
Ostergotland County Council, Sweden
Investigators
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Principal Investigator: Mats Hammar, MD, prof University Hospital, Linkoeping
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mats Hammar, Ostergotland County Council
ClinicalTrials.gov Identifier: NCT01087593    
Other Study ID Numbers: 151 662/01
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: March 16, 2010
Last Verified: September 2001
Keywords provided by Ostergotland County Council, Sweden:
estrogen
substitution
pain
hormonal levels
quantitative sensory testing
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female