Health TrialsbyHealthPanel

Novel Approaches to the Treatment of Hypothyroidism

ConditionHypothyroidism
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUConn Health

About this trial

Hypothyroidism is a common condition, more frequent in females, associated with excess of cardiovascular risk and poor quality of life not completely abrogated by treatment with levothyroxine.

There is an unmet need to define a safe, effective, and feasible regimen to be applied in large trials aimed at assessing levothyroxine/liothyronine combination therapy in patients living with hypothyroidism.

To address this knowledge gap we propose a randomized, three-arm, double-blind, controlled, escalating dose parallel pilot study whose results will lay the foundation of large multicenter trial(s) able to demonstrate the effectiveness (or lack thereof) of levothyroxine/liothyronine combination therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Levothyroxine

    Drug

    Patients will receive Levothyroxine/Placebo Levothyroxine/Liothyronine with Liothyronine administered twice daily.

  • Levothyroxine/Liothyronine once daily

    Drug

    Patients will receive Levothyroxine/Liothyronine with Liothyronine administered once daily;

  • Levothyroxine/Liothyronine twice daily

    Drug

    Patients will receive Levothyroxine/Liothyronine with Liothyronine administered twice daily;

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Levothyroxine aloneActive comparator 1 intervention
Group B: Combination therapy liothyronine once dailyExperimental treatment 2 interventions
Group C: Combination therapy liothyronine twice dailyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Changes in Total Cholesterol

Changes between groups

Time frame
6 month
2

Changes in LDL Cholesterol

Changes between groups

Time frame
6 month

Secondary outcomes

1

Changes in Weight

Changes between groups

Time frame
6 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UConn Health

Lead sponsor

Source ClinicalTrials.gov
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