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Hormone Replacement Therapy

Hormone Replacement Therapy for Hypothyroidism

Phase 2
Waitlist Available
Research Sponsored by Neuvosyn Laboratories, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with primary hypothyroidism
On continuous thyroid replacement therapy for at least 6 months before Study Entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 30
Awards & highlights

Study Summary

This trial studies how safely and effectively people can switch from regular thyroid medicine to a new kind of therapy.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, hormone replacement therapies like North Star and Levothyroxine can cause symptoms such as fatigue, weight changes, hair loss, mood swings, and sensitivity to cold if dosing isn't properly managed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with an underactive thyroid.
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I have been on thyroid replacement therapy for at least 6 months.
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I am not pregnant or breastfeeding.
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I have been diagnosed with an underactive thyroid.
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I have been on thyroid replacement therapy for at least 6 months.
Select...
I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The ratio of the LT4 dose (mcg/day) at screening to North Star (mg/day) at the end of the treatment period required to achieve and maintain serum thyroid-stimulating hormone (TSH) levels within the normal reference range.
Secondary outcome measures
Proportion of subjects who are euthyroid as determined by serum TSH level within the normal reference range at the end of the treatment period.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: North StarExperimental Treatment1 Intervention
Group II: LevothyroxineActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Neuvosyn Laboratories, LLCLead Sponsor

Media Library

North Star (Hormone Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05712421 — Phase 2
Hypothyroidism Research Study Groups: North Star, Levothyroxine
Hypothyroidism Clinical Trial 2023: North Star Highlights & Side Effects. Trial Name: NCT05712421 — Phase 2
North Star (Hormone Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05712421 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many facilities have been delegated to oversee this clinical experiment?

"The trial is available at 24 distinct medical facilities, including those in Canoga Park, Greenbrae and Toluca Lake. To reduce the amount of travel needed to participate, it's recommended that you choose a site nearby your residence."

Answered by AI

Is this research venture open to seniors aged eighty or more?

"This trial permits patients to enroll in it, who are aged between 18 and 75. In contrast, there exist 3 research projects geared towards minors under the age of 18 as well as 12 studies slated for seniors over 65 years old."

Answered by AI

What criteria should prospective participants of this trial meet?

"In order to qualify for this trial, individuals must be aged 18-75 and suffering from hypothyroidism. Upwards of 300 volunteers are needed in total."

Answered by AI

Has the North Star device received authorization from the FDA?

"Based on the available evidence, our team's assessment at Power is that North Star has a safety rating of 2. This reflects its status as being in Phase 2, where data suggests some level of security but no clinically proven efficacy yet."

Answered by AI

Is recruitment currently ongoing for this experiment?

"The information posted on clinicaltrials.gov confirms that this investigation is not seeking participants at present; it was first published February 1st, 2023 and its latest update occurred January 25th of the same year. Even so, 14 other trials are actively recruiting subjects currently."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
What site did they apply to?
Neuvosyn Investigational Site
Other

Why did patients apply to this trial?

I am curious if there is a better treatment option. I would like to help with the advancement of a cure.
PatientReceived no prior treatments
I'm currently taking Levothyroxine but still struggle with fatigue, depression and weight gain. Hoping to find a better solution.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study Evaluation the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Patients With Primary Hypothyroidism
2023. "A Study Evaluation the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Patients With Primary Hypothyroidism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05712421.
All > Hypothyroidism
~20 spots leftby Jun 2024
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