Study of T3 for the Treatment of Fibromyalgia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00903877 |
Recruitment Status :
Completed
First Posted : May 19, 2009
Results First Posted : July 14, 2017
Last Update Posted : July 14, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fibromyalgia | Drug: T3 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 51 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | T3 for Fibromyalgia: a Pilot Double-blind Non-randomized Clinical Trial |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Placebo followed by T3
Participants receive placebo for 4 weeks. Following placebo, participants begin T3 treatment at 25 mcg per day, for 4 weeks. Following this, participants begin T3 treatment at 50 mcg per day, for 4 more weeks.
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Drug: T3
Patients receive T3 in a dose of 25mcg and 50mcg |
- Visual Analogue Scale of Pain Intensity [ Time Frame: 12 weeks ]Patients rated their pain at baseline, placebo, T3 at 25 mcg, and T3 at 50 mcg. The scale ranged from 0 (no pain) to 10 (pain as bad as it can be).

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18-50
- Meet american college of rheumatology criteria for fibromyalgia
- at baseline report an average pain of 4 or more on a brief Pain Inventory.
- can climb 2 flights of stairs without shortness of breath.
Exclusion Criteria:
- new medication change in the last 2 months
- any cardiac disease at all
- known thyroid disease before or after thyroid screening bloodwork
- unstable medical or psychiatric disease.
- Known inflammatory or rheumatic disease other than fibromyalgia
- substance abuse in the last year
- suicidality or depression as indicated by a Beck Depression Inventory of 30 or above
- concomitant herbal medications
- multiple severe medication allergies
- the assessment of the research team that inclusion of the subject could in some way compromise the safety and validity of the study.
- diabetes
- smoking
- Known uncontrolled hypertension
- known uncontrolled hypercholesterolemia

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903877
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Ian R Carroll | Stanford University |
Responsible Party: | Sean Mackey, Assistant Professor, Stanford University |
ClinicalTrials.gov Identifier: | NCT00903877 |
Other Study ID Numbers: |
SU-04272009-2419 16295 |
First Posted: | May 19, 2009 Key Record Dates |
Results First Posted: | July 14, 2017 |
Last Update Posted: | July 14, 2017 |
Last Verified: | June 2017 |
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |