T4/T3 Therapy for Hypothyroidism

AR
TS
Overseen ByTheresa Scattergood, MSN, RN
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Pennsylvania
Must be taking: Levothyroxine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will test whether 6 months of combination therapy with levothyroxine (LT4) plus liothyronine (LT3) is superior to LT4 plus placebo in participants with hypothyroidism who have residual symptoms of hypothyroidism with TSH levels within the reference range.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 70 years old.
I have had hypothyroidism from thyroid failure or removal for at least 6 months.
I have been taking 75-150 mcg of LT4 daily at a stable dose for at least 3 months.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take LT4+LT3 or LT4+placebo for 6 months

6 months
Clinic visits at the beginning and end, blood tests at 6 and 13 weeks, symptom checks weekly to monthly

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • T4/T3 Therapy

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: LT4+LT3Experimental Treatment2 Interventions
Group II: LT4+placeboActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+