Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia

This study has been terminated.

(Due to ethical concerns regard to the results from the WHI study)

Sponsor:

Information provided by:

Ostergotland County Council, Sweden

ClinicalTrials.gov Identifier:

NCT01087593

First received: March 15, 2010

Last updated: NA

Last verified: September 2001

History: No changes posted

Tracking Information

First Received Date ^ICMJE

March 15, 2010

Last Updated Date

March 15, 2010

Start Date ^ICMJE

August 2001

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pain thresholds and pain tolerance [ Time Frame: Before and after eight weeks treatment ] [ Designated as safety issue: No ]

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Arm (s)

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. 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

Enrollment ^ICMJE

Completion Date

October 2007

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

Gender

Female

Ages

40 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT01087593

Other Study ID Numbers ^ICMJE

151 662/01

Has Data Monitoring Committee

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

Information Provided By

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

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