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Thyroid Hormone Replacement
Levothyroxine Sodium for Hypothyroidism
Phase 4
Waitlist Available
Led By Vijiya Surampudi, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
Summary
This trial is testing a liquid form of levothyroxine to see if it better manages thyroid function in patients with hypothyroidism who use feeding tubes. These patients often struggle with traditional tablet forms of the medication. The liquid form is expected to be absorbed more consistently, potentially improving their thyroid levels and symptoms. Levothyroxine is a standard therapy for hypothyroidism, and liquid formulations have been shown to provide better absorption and thyroid hormone control compared to tablet forms.
Eligible Conditions
- Hypothyroidism
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change of TSH
Secondary study objectives
percentage of patients with therapeutic FT3
percentage of patients with therapeutic FT4
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Liquid Levothyroxine ManagementExperimental Treatment1 Intervention
Participants will be treated with dose equivalent regimen through enteral feeding tube
Group II: Standard Levothyroxine ManagementActive Control1 Intervention
Participants will continue with the same regimen
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levothyroxine
FDA approved
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,564 Previous Clinical Trials
10,262,630 Total Patients Enrolled
Vijiya Surampudi, MDPrincipal InvestigatorUniversity of California, Los Angeles
1 Previous Clinical Trials
150 Total Patients Enrolled
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