Hormone Replacement Therapy for Hypothyroidism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal dose of a new hormone replacement therapy called North Star for individuals with hypothyroidism, a condition where the thyroid produces insufficient hormones. Researchers will compare North Star to the commonly used treatment, Levothyroxine, to assess safety and effectiveness. The trial seeks participants who have maintained a steady Levothyroxine dose for at least three months. Those managing hypothyroidism with medication for some time may be suitable candidates for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant medical advancements.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that North Star was safe in earlier studies. These studies suggest that people generally handle the treatment well. No major reports of adverse side effects have emerged, indicating that most patients did not experience serious problems while using North Star.
The current research focuses on ensuring that patients can safely switch from Levothyroxine, a common thyroid medication, to North Star. So far, the results are promising, indicating that North Star might be a safe option for people with hypothyroidism.12345Why do researchers think this study treatment might be promising for hypothyroidism?
Unlike the standard treatment for hypothyroidism, which typically involves levothyroxine—a synthetic form of the thyroid hormone—North Star is an experimental therapy that offers a novel approach. Researchers are excited about North Star because it might have a different mechanism of action or delivery method that could provide more consistent hormone levels or fewer side effects. This innovative approach could potentially offer a new option for patients who don't respond well to traditional treatments or who experience unwanted side effects.
What evidence suggests that North Star might be an effective treatment for hypothyroidism?
Research has shown that North Star therapy, a treatment under study in this trial, might effectively treat hypothyroidism. Early studies suggest that patients switching from Levothyroxine, the trial's active comparator, to North Star can maintain stable thyroid hormone levels. This stability is crucial for managing hypothyroidism symptoms, such as fatigue and weight gain. Although detailed results are not yet available, early data appears promising, indicating that North Star could be a safe alternative. It may offer a different option for those not fully satisfied with Levothyroxine.15678
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo dose conversion from Levothyroxine to North Star therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Levothyroxine
- North Star
Find a Clinic Near You
Who Is Running the Clinical Trial?
Neuvosyn Laboratories, LLC
Lead Sponsor