Hormone Replacement Therapy for Hypothyroidism

Recruiting at23 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Neuvosyn Laboratories, LLC

No Placebo Group

Prior Safety Data

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.

Research Team

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.

Treatment Details

Interventions

• Levothyroxine (Hormone Replacement Therapy)
• North Star (Hormone Replacement Therapy)

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+