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Thyroid Hormone Replacement
Thyroid Hormone Therapy for Hypothyroidism
N/A
Waitlist Available
Research Sponsored by Walter Reed National Military Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects will be between the ages of 18 to 65 and will have been on levothyroxine for primary hypothyroidism for at least 6 months
Be older than 18 years old
Must not have
Subjects will be excluded if they have the following problems: pregnancy, plan for pregnancy in the next 12 months, cardiac disease, especially coronary artery disease, chronic obstructive lung disease, malabsorption disorder, gastrointestinal surgeries, significant renal or liver dysfunction, seizure disorders, thyroid and non-thyroid active cancers, uncontrolled psychosis, psychotropic medication use, steroid use, amiodarone, chemotherapy for cancer, iron supplement more than 325mg per day, carafate/ proton pump inhibitor use, cholestyramine use, and those with recent orders who are expected to move out of the geographic area, age less than 18 years old or older than 65 years old. Patients scheduled for deployment will be excluded.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Summary
This trial is a study to compare the effect of different thyroid treatments on memory and other symptoms in patients with hypothyroidism.
Who is the study for?
This trial is for Department of Defense beneficiaries near Bethesda, MD, aged 18-65 with primary hypothyroidism treated with levothyroxine for at least 6 months. Exclusions include pregnancy or planning to become pregnant, heart and lung diseases, severe kidney/liver issues, certain mental health conditions, and those on specific medications.
What is being tested?
The study compares three thyroid hormone treatments: desiccated thyroid extract (DTE), synthetic T3/T4 combo (ThyrolarTM), and L-T4 alone in a blinded crossover design. Participants will switch between treatments every three months to assess effectiveness on memory, well-being, and other health parameters.
What are the potential side effects?
Potential side effects may include changes in energy levels, heart rate irregularities due to altered thyroid hormone levels; skin reactions; gastrointestinal disturbances like diarrhea or constipation; weight fluctuations; and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18-65 years old and have been taking levothyroxine for my thyroid condition for at least 6 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Beck Depression Inventory
Thyroid Symptom Questionnaire (TSQ)
Wechsler memory scale, fourth edition (WMS-IV)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Active Control
Group I: Levothyroxine Plus Liothyronine GroupActive Control1 Intervention
Levothyroxine Plus Liothyronine Group
Group II: Levothyroxine GroupActive Control1 Intervention
Levothyroxine Group
Group III: Desiccated Thyroid Extract GroupActive Control1 Intervention
Desiccated Thyroid Extract Group
Find a Location
Who is running the clinical trial?
Walter Reed National Military Medical CenterLead Sponsor
143 Previous Clinical Trials
33,246 Total Patients Enrolled
1 Trials studying Hypothyroidism
180 Patients Enrolled for Hypothyroidism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People with a mild form of underactive thyroid will not be included in the study. This is because it may be hard to see if the treatments work for them.I am not pregnant or at risk of becoming pregnant.I am 18-65 years old and have been taking levothyroxine for my thyroid condition for at least 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Levothyroxine Plus Liothyronine Group
- Group 2: Levothyroxine Group
- Group 3: Desiccated Thyroid Extract Group
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Hypothyroidism Patient Testimony for trial: Trial Name: NCT02317926 — N/A