Study Stopped
Due to ethical concerns regard to the results from the WHI study
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
1 other identifier
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2001
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 15, 2010
CompletedFirst Posted
Study publicly available on registry
March 16, 2010
CompletedMarch 16, 2010
September 1, 2001
6.2 years
March 15, 2010
March 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain thresholds and pain tolerance
Before and after eight weeks treatment
Study Arms (2)
Treatment with transdermal 17β-estradiol
EXPERIMENTALControl
PLACEBO COMPARATORInterventions
Transdermal administration(50 ug daily)for a period of ten weeks with additional treatment of medroxyprogesterone (10mg daily) for the last two weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University hospital in Linköping
Linköping, 581 85, Sweden
Related Publications (1)
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.
PMID: 21078629DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mats Hammar, MD, prof
University Hospital, Linkoeping
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 15, 2010
First Posted
March 16, 2010
Study Start
August 1, 2001
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
March 16, 2010
Record last verified: 2001-09