CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 52 enrolled
Drug / intervention
Levothyroxine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04288115
NCT04288115Phase 4Completed
CompareCT.gov

Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism: a Pilot Randomized, Double-blinded, Placebo-controlled Study

VA Office of Research and Development·interventional·Posted Feb 28, 2020·Updated Nov 18, 2023

In Brief

A Phase 4 clinical trial evaluating Levothyroxine and Placebo for Subclinical Hypothyroidism. Completed, enrolled 52 participants across 1 site.

Detailed Summary

The investigators propose the following hypothesis: discontinuation of levothyroxine (LT4) for veterans with subclinical hypothyroidism (SCH) will be feasible, acceptable, and safe and will not negatively affect their Quality of Life (QoL). The investigators aim to evaluate the feasibility of LT4 discontinuation among veterans with SCH and determine the changes in QoL measures, lipids, and adverse events.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSubclinical Hypothyroidism
CountriesUnited States
CollaboratorsCentral Arkansas Veterans Healthcare System

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedFeb 28, 2020
Enrollment StartMar 24, 2021
Primary CompletionOct 7, 2022
Study CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.3 years ago

Interventions

Levothyroxinedrug

Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.

Placeboother

Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.