HypothyroidismPhase 2NCT04124705

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

A Phase 2 study testing Armour® Thyroid and Levothyroxine in people with Hypothyroidism and Thyroid Disease, run by Allergan at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will evaluate the safe and effective dose conversion from levothyroxine (synthetic T4) therapy to Armour Thyroid therapy in participants who are on a stable dose of levothyroxine and have thyroid stimulating hormone (TSH) levels within the normal reference range. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hypothyroidism, Thyroid Disease, Euthyroid
What is being tested?: Armour® Thyroid and Levothyroxine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 284 participants
Where: 28 sitesUnited States
Study dates: 11 Oct 2019to 22 Jun 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants who have a diagnosis of primary hypothyroidism made ≥ 12 months before study entry (Visit 1).
Be on continuous thyroid replacement therapy with synthetic T4 for primary hypothyroidism for at least 12 months immediately prior to the Screening Visit (Visit 1).
Be on a stable Food and Drug Administration (FDA)-approved daily dose of synthetic T4 for a minimum of 3 months prior to the Screening Visit (Visit 1). Must enter the study on the same stable dose.
Have euthyroid status indicated by at least 1 documented TSH value within normal reference range (0.45 - 4.12 mIU/L, inclusive) at a minimum of 6 weeks and maximum of 12 months prior to the Screening Visit (Visit 1). Also have a confirmed TSH value within the normal reference range drawn at the Screening Visit (Visit 1).
Male and female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period (35 days after last dose of study intervention).

Who cannot join

Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of Armour Thyroid or synthetic T4.
History of alcohol or other substance abuse within the previous 5 years.
Known or suspected allergy or intolerance to any ingredients of Armour Thyroid, including its excipients, levothyroxine (T4), other thyroid replacement medications, or pork products.
Have received active treatment with an investigational drug within 30 days or 5 half lives, whichever is longer, of Screening Visit (Visit 1).
Current enrollment in an investigational drug or device study or participation in such a study within 60 days of entry into this study.

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

Sponsor Site /ID# 235202
Asheville, North Carolina, 28803
Sponsor Site /ID# 235032
Atlanta, Georgia, 30318
Sponsor Site /ID# 237137
Austin, Texas, 78731
Sponsor Site/ID# 238071
Austin, Texas, 78749
Sponsor Site /ID# 237950
Birmingham, Alabama, 35205
Sponsor Site /ID# 237199
Columbus, Georgia, 31904
Sponsor Site/ID# 237652
Dallas, Texas, 75231
Sponsor Site/ID# 237655
Dallas, Texas, 75231
Sponsor Site/ID# 235866
Denver, Colorado, 80246
Sponsor Site /ID# 235870
El Paso, Texas, 79935
Sponsor Site /ID# 235853
Fort Lauderdale, Florida, 33312
Sponsor Site /ID# 235210
Greenbrae, California, 94904
Sponsor Site/ID# 235204
Greenville, North Carolina, 27834
Sponsor Site /ID# 238023
Hickory, North Carolina, 28601
Sponsor Site /ID# 235716
Huntington Beach, California, 92648
Sponsor Site /ID# 238088
Lawrenceville, Georgia, 30046
Sponsor Site /ID# 235714
Lexington, Kentucky, 40503
Sponsor Site /ID# 237986
Little Rock, Arkansas, 72209-7040
Sponsor Site /ID# 236701
Louisville, Kentucky, 40213-1014
Sponsor Site /ID# 235211
Renton, Washington, 98057
Sponsor Site /ID# 235860
Round Rock, Texas, 78681
Sponsor Site /ID# 238120
Sacramento, California, 95821-2123
Sponsor Site /ID# 235894
San Antonio, Texas, 78229
Sponsor Site /ID# 238026
Santa Clarita, California, 91321
Sponsor Site /ID# 236022
Spokane, Washington, 99202
Sponsor Site/ID# 236977
Tacoma, Washington, 98405
Sponsor Site /ID# 238258
Van Nuys, California, 91405-3605
Sponsor Site /ID# 236809
West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-blind, Dose-conversion Study to Evaluate the Safety and Efficacy of Hormone Replacement Therapy With Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants Who Are Euthyroid on T4 Replacement Therapy

Read the detailed description

This study will include will include a Screening Period, double-blinded Titration Period (at least 18 weeks, up to 36 weeks), and a double-blinded Stabilization Period (12 weeks).

Participants will be randomized to receive either their same dose of levothyroxine or an approximately, matching dose of Armour Thyroid, using a dose-conversion chart based on the United States Pharmacopeia (USP) Drug Information 2000, which states that 1 grain of Armour Thyroid is equivalent to 100 mcg of levothyroxine.

During the Titration Period, Investigators will have the option to up-or down-titrate a participant's dose as needed based on the participant's TSH level (normal reference range 0.45 - 4.12 mIU/L, inclusive). At Week 18, if a participant's TSH levels are not within the normal reference range, the Investigator may up-or down-titrate the dose by continuing the Titration Period beyond Week 18 for up to a maximum of 3 additional titrations at 6-week intervals. Participants whose TSH levels have not normalized after the maximum 3 additional titrations will not enter the Stabilization Period.

At the end of the Titration Period, participants with TSH levels within normal reference range may enter the Stabilization Period. Depending on whether a participant requires additional dose titration after the Week 18 visit, the Stabilization Period may end at Week 30, 36, 42, or 48.

Conditions: Hypothyroidism, Thyroid Disease, Euthyroid, Thyroid Gland, Thyroid Hormones
Being tested: Armour® Thyroid, Levothyroxine
Medical subject headings: Hypothyroidism, Thyroid Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Armour® ThyroidDrug
Also called Desiccated thyroid extract, AGN-204771
Administered orally once a day. the daily dose could range from 1/4 - 2 grains.
LevothyroxineDrug
Also called Synthetic T4
Administered orally once a day; the daily dose could range from 25- 200 µg.

Study groups in NCT04124705
Study group	Role	What they receive
Armour® Thyroid	Experimental	Participants were randomized to receive Armour Thyroid at a dose corresponding to their pre-randomized dose of synthetic T4. During the first 18 to 36 weeks (titration period) the dose of Armour Thyroid could be titrated based on levels of thyroid stimulating hormone (TSH), in order to achieve TSH levels within the normal reference range (0.45 - 4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of Armour Thyroid for an additional 12 weeks (stabilization period). Receives: Drug: Armour® Thyroid
Levothyroxine	Active comparator	Participants were randomized to receive levothyroxine at their pre-randomized dose. During the first 18 to 36 weeks (titration period) the dose of levothyroxine could be titrated based on levels of TSH in order to achieve TSH levels within the normal reference range (0.45-4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of levothyroxine for an additional 12 weeks (stabilization period). Receives: Drug: Levothyroxine

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With a Sustained TSH Response
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.
Measured: 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).

Secondary outcomes (1)

Percentage of Participants With a Titration TSH Response
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.
Measured: End of the titration period (Week 18, 24, 30, or 36)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 201922 Jun 2021

First posted11 Oct 2019
Study start11 Oct 2019
Primary completion22 Jun 2021
Study completion22 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypothyroidismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 284 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04124705
Sponsor's protocol ID: 3014-201-002
Status last verified: May 2024
First submitted: 10 Oct 2019
Last updated: 5 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
Active, not recruitingPhase 4
Comparison of Two Timings of Levothyroxine Intake in Hypothyroid Patients: A Cross-over Randomized Control Trial
Hypothyroidism Primary
RecruitingObservational study
Understanding the Subnormal Rescue ofNeurological Development in Congenital Hypothyroidism (2022E5SZEM)
Congenital Hypothyroidism, Neurodevelopmental Disorders
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia

All Hypothyroidism trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Dose-conversion Study to Evaluate the Safety and Efficacy of Hormone Replacement Therapy With Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants Who Are Euthyroid on T4 Replacement Therapy
ClinicalTrials.gov ID: NCT04124705
Acronym / sponsor ID: 3014-201-002
Conditions: Hypothyroidism, Thyroid Disease, Euthyroid, Thyroid Gland, Thyroid Hormones
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 284 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 11 Oct 2019 (actual)
Primary completion: 22 Jun 2021 (actual)
Study completion: 22 Jun 2021 (actual)
First posted: 11 Oct 2019 (actual)
Results: Posted 5 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study will include will include a Screening Period, double-blinded Titration Period (at least 18 weeks, up to 36 weeks), and a double-blinded Stabilization Period (12 weeks).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Armour® Thyroid	Experimental	Drug: Armour® ThyroidParticipants were randomized to receive Armour Thyroid at a dose corresponding to their pre-randomized dose of synthetic T4. During the first 18 to 36 weeks (titration period) the dose of Armour Thyroid could be titrated based on levels of thyroid stimulating hormone (TSH), in order to achieve TSH levels within the normal reference range (0.45 - 4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of Armour Thyroid for an additional 12 weeks (stabilization period).
Levothyroxine	Active comparator	Drug: LevothyroxineParticipants were randomized to receive levothyroxine at their pre-randomized dose. During the first 18 to 36 weeks (titration period) the dose of levothyroxine could be titrated based on levels of TSH in order to achieve TSH levels within the normal reference range (0.45-4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of levothyroxine for an additional 12 weeks (stabilization period).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Participants who have a diagnosis of primary hypothyroidism made ≥ 12 months before study entry (Visit 1).
Be on continuous thyroid replacement therapy with synthetic T4 for primary hypothyroidism for at least 12 months immediately prior to the Screening Visit (Visit 1).
Be on a stable Food and Drug Administration (FDA)-approved daily dose of synthetic T4 for a minimum of 3 months prior to the Screening Visit (Visit 1). Must enter the study on the same stable dose.
Have euthyroid status indicated by at least 1 documented TSH value within normal reference range (0.45 - 4.12 mIU/L, inclusive) at a minimum of 6 weeks and maximum of 12 months prior to the Screening Visit (Visit 1). Also have a confirmed TSH value within the normal reference range drawn at the Screening Visit (Visit 1).
Male and female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period (35 days after last dose of study intervention).

Key exclusion criteria (5 listed)

Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of Armour Thyroid or synthetic T4.
History of alcohol or other substance abuse within the previous 5 years.
Known or suspected allergy or intolerance to any ingredients of Armour Thyroid, including its excipients, levothyroxine (T4), other thyroid replacement medications, or pork products.
Have received active treatment with an investigational drug within 30 days or 5 half lives, whichever is longer, of Screening Visit (Visit 1).
Current enrollment in an investigational drug or device study or participation in such a study within 60 days of entry into this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Armour® ThyroidAlso: Desiccated thyroid extract, AGN-204771Administered orally once a day. the daily dose could range from 1/4 - 2 grains.	Drug	Armour® Thyroid
LevothyroxineAlso: Synthetic T4Administered orally once a day; the daily dose could range from 25- 200 µg.	Drug	Levothyroxine

Primary outcome

Percentage of Participants With a Sustained TSH Response
Time frame: 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.

1 secondary outcome

Percentage of Participants With a Titration TSH Response
Time frame: End of the titration period (Week 18, 24, 30, or 36)

Results and safety

Results posted to the registry on 5 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Armour® Thyroid	141	115
Levothyroxine	143	124

Primary outcome: Percentage of Participants With a Sustained TSH Response

Time frame: 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).. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Armour® Thyroid n = 141	Levothyroxine n = 143
Value	60.76 (52.60 to 68.92)	75.92 (68.65 to 83.19)

Armour® Thyroid vs Levothyroxine: Stratified Response Rate Difference: -15.16 (95% CI -26.10 to -4.23)

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first dose of study drug up to 35 days after last dose; maximum time on study was 48 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Armour® Thyroid	4 of 141 (2.8%)	15 of 141 (10.6%)	1 of 141
Levothyroxine	7 of 143 (4.9%)	9 of 143 (6.3%)	1 of 143

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Related trials for Hypothyroidism

Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
Active, not recruitingPhase 4
Comparison of Two Timings of Levothyroxine Intake in Hypothyroid Patients: A Cross-over Randomized Control Trial
Hypothyroidism Primary
RecruitingObservational study
Understanding the Subnormal Rescue ofNeurological Development in Congenital Hypothyroidism (2022E5SZEM)
Congenital Hypothyroidism, Neurodevelopmental Disorders
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ALLERGAN INC. study director

Allergan

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Armour® Thyroid and Levothyroxine in people with Hypothyroidism and Thyroid Disease, run by Allergan at 28 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a Sustained TSH Response (time frame: 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04124705.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.