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TerminatedNCT01087593Updated Mar 16, 2010

Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia

An interventional study of 17β-estradiol in Fibromyalgia, sponsored by Ostergotland County Council, Sweden. Terminated at 1 site in Sweden. Open to female participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2010-03-16.

Sponsored by Ostergotland County Council, Sweden · Not applicable, Interventional, and Basic science

Why this study was terminated
Due to ethical concerns regard to the results from the WHI study
Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
Female
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Study 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.

Read the 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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Conditions studied

  • Fibromyalgia

Keywords

  • estrogen
  • substitution
  • pain
  • hormonal levels
  • quantitative sensory testing
03

In context

Fibromyalgia

1,369 studies on the registry are indexed under Fibromyalgia; 272 are open to participants now.

This study's enrollment of 29 is below the median of 60 across 1,056 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Ostergotland County Council, Sweden is the lead sponsor of 18 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Treatment with transdermal 17β-estradiol

    Drug: 17β-estradiol

  • Placebo comparator
    Control

    Drug: 17β-estradiol

Interventions

  • Transdermal administration(50 ug daily)for a period of ten weeks with additional treatment of medroxyprogesterone (10mg daily) for the last two weeks

    Also known as: Evorel, provera

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What researchers measure

Primary outcomes

  1. Pain thresholds and pain tolerance

    Time frame: Before and after eight weeks treatment

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Study locations

1 site
  • University hospital in Linköping
    Linköping, 581 85, Sweden
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References and documents

Publications

  • 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. PubMed 21078629 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01087593
Lead sponsor
Ostergotland County Council, Sweden
First posted
Mar 16, 2010
Start date
Aug 2001
Primary completion
Oct 2007
Completion
Oct 2007
Last update
Mar 16, 2010

Study contacts

Mats Hammar, MD, prof
principal investigator · University Hospital, Linkoeping

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2001. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Estradiol

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