Clinical Trials Directory

Trials / Terminated

TerminatedNCT01087593

Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
29 (actual)
Sponsor
Ostergotland County Council, Sweden · Academic / Other
Sex
Female
Age
40 Years – 60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUG17β-estradiolTransdermal administration(50 ug daily)for a period of ten weeks with additional treatment of medroxyprogesterone (10mg daily) for the last two weeks

Timeline

Start date
2001-08-01
Primary completion
2007-10-01
Completion
2007-10-01
First posted
2010-03-16
Last updated
2010-03-16

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT01087593. Inclusion in this directory is not an endorsement.