Trial · NCT04124705

A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants

NCT04124705, Phase 2, Completed, Allergan; results first posted 2024-06-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants. Trials, record NCT04124705. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04124705

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants
NCT number: NCT04124705
Status: Completed
Phases: Phase 2
Enrollment: 284 participants, actual
Lead sponsor: Allergan
Conditions: Hypothyroidism, Thyroid Disease, Euthyroid, Thyroid Gland, Thyroid Hormones
Interventions: Armour® Thyroid, Levothyroxine
First posted: 2019-10-11
Last updated: 2024-06-05
Results first posted: 2024-06-05

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With a Sustained TSH Response	End of the titration period (Week 18, 24, 30, or 36) and end of the stabilization period (Week 30, 36, 42, or 48, depending on the length of the titration period).	Sustained TSH response is defined as TSH values that are within the normal reference range of 0.45 to 4.12 mIU/L, inclusive, at both the end of Titration Period and the end of the Stabilization Period.
Secondary	Percentage of Participants With a Titration TSH Response	End of the titration period (Week 18, 24, 30, or 36)	Titration TSH Response is defined as having a TSH value within the normal reference range of 0.45 to 4.12 mIU/L, inclusive, at the end of the Titration Period.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With a Sustained TSH Response	End of the titration period (Week 18, 24, 30, or 36) and end of the stabilization period (Week 30, 36, 42, or 48, depending on the length of the titration period).	All randomized participants who took at least 1 dose of study intervention (intent-to-treat population). The non-responder imputation incorporating multiple imputation to handle missing data due to coronavirus disease 2019 (COVID-19) (NRI-C) was performed for participants who had missing TSH values either at the end of the Titration Period or at the end of the Stabilization Period.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With a Titration TSH Response	End of the titration period (Week 18, 24, 30, or 36)	All randomized participants who took at least 1 dose of study intervention (intent-to-treat population). The non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was performed for participants who had missing TSH values at the end of Titration Period.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Participants With a Sustained TSH Response	Armour® Thyroid	60.76	95% Confidence Interval 52.60 to 68.92	percentage of participants
Percentage of Participants With a Sustained TSH Response	Levothyroxine	75.92	95% Confidence Interval 68.65 to 83.19	percentage of participants
Percentage of Participants With a Titration TSH Response	Armour® Thyroid	80.62	95% Confidence Interval 74.05 to 87.18	percentage of participants
Percentage of Participants With a Titration TSH Response	Levothyroxine	91.13	95% Confidence Interval 86.35 to 95.92	percentage of participants

Source ClinicalTrials.gov

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Titration Period	STARTED	Armour® Thyroid	141
Titration Period	STARTED	Levothyroxine	143
Titration Period	Received Study Treatment	Armour® Thyroid	141
Titration Period	Received Study Treatment	Levothyroxine	143
Titration Period	COMPLETED	Armour® Thyroid	115
Titration Period	COMPLETED	Levothyroxine	124
Titration Period	NOT COMPLETED	Armour® Thyroid	26
Titration Period	NOT COMPLETED	Levothyroxine	19
Stabilization Period	STARTED	Armour® Thyroid	115
Stabilization Period	STARTED	Levothyroxine	124

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events32

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	FATIGUE	General disorders	Armour® Thyroid	7	141	7
other	FATIGUE	General disorders	Levothyroxine	8	143	8
other	ANXIETY	Psychiatric disorders	Armour® Thyroid	8	141	8
other	ANXIETY	Psychiatric disorders	Levothyroxine	1	143	1
serious	CARDIO-RESPIRATORY ARREST	Cardiac disorders	Armour® Thyroid	0	141	0
serious	CARDIO-RESPIRATORY ARREST	Cardiac disorders	Levothyroxine	1	143	1
serious	CORONARY ARTERY DISEASE	Cardiac disorders	Armour® Thyroid	1	141	1
serious	CORONARY ARTERY DISEASE	Cardiac disorders	Levothyroxine	0	143	0
serious	SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	Armour® Thyroid	1	141	1
serious	SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	Levothyroxine	0	143	0

1 to 10 of 32Source ClinicalTrials.gov

See all 32 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Armour® Thyroid	1	141
Total, all-cause mortality	Levothyroxine	1	143
Total, other adverse events	Armour® Thyroid	15	141
Total, other adverse events	Levothyroxine	9	143
Total, serious adverse events	Armour® Thyroid	4	141
Total, serious adverse events	Levothyroxine	7	143

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Armour® Thyroid vs Levothyroxine: deaths from any cause	Trial comparisons
Armour® Thyroid vs Levothyroxine: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04124705

GET https://conductscience.org/api/trials/v1/NCT04124705/events?page=2

API reference For AI assistants