FibromyalgiaNCT01087593
Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia
A study testing 17β-estradiol in people with Fibromyalgia, run by Ostergotland County Council, Sweden at 1 site in Sweden.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- 17β-estradiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2001to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Fibromyalgia
- Being tested
- 17β-estradiol
- Keywords
- estrogen, substitution, pain, hormonal levels, quantitative sensory testing
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17β-estradiolDrug
Also called Evorel, provera
Transdermal administration(50 ug daily)for a period of ten weeks with additional treatment of medroxyprogesterone (10mg daily) for the last two weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment with transdermal 17β-estradiol | Experimental | Not described Receives: Drug: 17β-estradiol |
| Control | Placebo comparator | Not described Receives: Drug: 17β-estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain thresholds and pain tolerance
Measured: Before and after eight weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startAug 2001
- Primary completionOct 2007
- Study completionOct 2007
Why it stopped: Due to ethical concerns regard to the results from the WHI study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostergotland County Council, Sweden
- Sponsor type
- University, hospital or other
- Investigators
- Mats Hammar, MD, prof, Principal investigator, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087593
- Sponsor's protocol ID
- 151 662/01
- Status last verified
- Sep 2001
- First submitted
- 15 Mar 2010
- Last updated
- 16 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01087593
- Acronym / sponsor ID
- 151 662/01
- Conditions
- Fibromyalgia
- Keywords
- estrogen, substitution, pain, hormonal levels, quantitative sensory testing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to ethical concerns regard to the results from the WHI study
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Ostergotland County Council, SwedenUniversity, hospital or other
- Study start
- Aug 2001
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 16 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with transdermal 17β-estradiol | Experimental | Drug: 17β-estradiol |
| Control | Placebo comparator | Drug: 17β-estradiol |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 17β-estradiolAlso: Evorel, proveraTransdermal administration(50 ug daily)for a period of ten weeks with additional treatment of medroxyprogesterone (10mg daily) for the last two weeks | Drug | Control, Treatment with transdermal 17β-estradiol |
Primary outcome
Pain thresholds and pain tolerance
Time frame: Before and after eight weeks treatment
Results and safety
The study was stopped early (reason given: Due to ethical concerns regard to the results from the WHI study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2010.
- Derived from this study: PubMed 21078629Stening 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mats Hammar, MD, prof principal investigator
University Hospital, Linkoeping
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 17β-estradiol in people with Fibromyalgia, run by Ostergotland County Council, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to ethical concerns regard to the results from the WHI study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain thresholds and pain tolerance (time frame: Before and after eight weeks treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01087593, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2010.