Hormone Replacement Therapy for Hypothyroidism

Recruiting at 23 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Neuvosyn Laboratories, LLC

Must be taking: Thyroid replacement

Disqualifiers: Major illness, Pregnancy, Surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if patients can safely switch from Levothyroxine to North Star therapy while keeping their thyroid hormone levels stable.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you should not start or change any medications during the study. It also prohibits the use of certain medications or supplements, so you may need to discuss your current medications with the study team.

What data supports the effectiveness of the drug Levothyroxine for treating hypothyroidism?

Levothyroxine is effective in treating hypothyroidism by restoring normal thyroid function, as it helps normalize thyrotropin (TSH) levels, which is a key measure of treatment success. Studies have shown that thyroid hormone replacement therapy can improve symptoms and reduce cardiovascular risk factors in patients with hypothyroidism. ^{1 2 3 4 5}

Is hormone replacement therapy for hypothyroidism safe?

Levothyroxine, a common treatment for hypothyroidism, is generally safe when used correctly, but over-replacement can lead to side effects like anxiety, muscle wasting, osteoporosis, and heart issues. It's important to monitor thyroid levels regularly to adjust the dosage and minimize risks. ^{6 7 8 9 10}

How does the drug North Star differ from other treatments for hypothyroidism?

The drug North Star may offer a unique approach to treating hypothyroidism by potentially addressing issues of absorption and compliance that are common with standard levothyroxine therapy, which is often ineffective for some patients due to these challenges. ^{9 11 12 13 14}

Eligibility Criteria

This trial is for adults with primary hypothyroidism who've been on a stable dose of Levothyroxine for at least 12 weeks. Participants must not be pregnant, agree to use reliable contraception, and cannot have conditions affecting drug absorption or excretion. They shouldn't have had major illness hospitalization recently or be taking certain other medications.

Inclusion Criteria

Agree to practice a method of contraception

I have been diagnosed with an underactive thyroid.

I have been on thyroid replacement therapy for at least 6 months.

Exclusion Criteria

I am not pregnant, nursing, or planning to become pregnant during the study.

I have not been hospitalized for a serious illness in the last 4 weeks.

I expect to start or change my current medications soon.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo dose conversion from Levothyroxine to North Star therapy

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Levothyroxine
• North Star

Trial Overview The study compares the safety and effectiveness of a new hormone therapy called North Star against the standard treatment, Levothyroxine, in people with underactive thyroid glands. It's a Phase 2 trial where patients are randomly assigned to one of the treatments without knowing which one they receive.

Participant Groups

Group I: North Star Experimental Treatment 1 Intervention

Group II: Levothyroxine Active Control 1 Intervention

Who Is Running the Clinical Trial?

Neuvosyn Laboratories, LLC

Lead Sponsor

Trials

1

Recruited

300+

Findings from Research

Only 56% of the 400 outpatients receiving levothyroxine therapy were monitored according to the minimum recommended guidelines, highlighting a significant gap in patient care.

Patients who received proper monitoring experienced fewer adverse drug events (ADEs) related to levothyroxine (1% vs. 6%), and minority status and non-English language were associated with higher rates of these ADEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of the adequacy of outpatient monitoring of thyroid replacement therapy. Stelfox, HT., Ahmed, SB., Fiskio, J., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Suboptimal Thyroid Hormone Replacement Is Associated With Worse Hospital Outcomes. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Bone density is not reduced during the short-term administration of levothyroxine to postmenopausal women with subclinical hypothyroidism: a randomized, prospective study. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[Autoimmune thyroiditis. Treatment with thyroid gland hormones in subclinical hypothyroidism or already in euthyroid state?]. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment with thyroid hormone. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluating health outcomes in the treatment of hypothyroidism. [2023]

6. England pubmed.ncbi.nlm.nih.gov

An evaluation of the adequacy of outpatient monitoring of thyroid replacement therapy. [2019]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Hypothyroidism in the elderly: pathophysiology, diagnosis and treatment. [2018]

8. Canada pubmed.ncbi.nlm.nih.gov

Risks Associated with Treating Hypothyroidism: Potential hazards of L-thyroxine therapy. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

ITALIAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS STATEMENT-REPLACEMENT THERAPY FOR PRIMARY HYPOTHYROIDISM: A BRIEF GUIDE FOR CLINICAL PRACTICE. [2021]

10. Spain pubmed.ncbi.nlm.nih.gov

[How we treat subclinical hypothyroidism in our daily clinical practice]. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

[Hypothyroidism due to pseudo-malabsorption of levothyroxine--Case 12/2009]. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

Hypothyroidism: an update. [2013]

13. Switzerland pubmed.ncbi.nlm.nih.gov

The Swinging Pendulum in Treatment for Hypothyroidism: From (and Toward?) Combination Therapy. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Resting Energy Expenditure in Obese Women with Primary Hypothyroidism and Appropriate Levothyroxine Replacement Therapy. [2021]