A Randomized, Double-blind, Dose-Conversion Study to Evaluate the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Subjects With Primary Hypothyroidism Who Are Euthyroid on Levothyroxine Replacement Therapy
Status: Completed
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The North Star study is a multi-center, Phase 2, double-blind, randomized, parallel group clinical study to evaluate the safe and effective dose conversion from Levothyroxine to North Star therapy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Diagnosed with primary hypothyroidism
• On continuous thyroid replacement therapy for at least 6 months before Study Entry
• On a stable daily dose of LT4 for a minimum of 12 weeks prior to Screening
• Agree to practice a method of contraception
• Female patients not pregnant or lactating at Screening
• Agree to practice a method of contraception of greater than 90% reliability
• Willing to give written informed consent for the Study
• Provide written authorization for use and disclosure of protected health information
Locations
United States
Alabama
Neuvosyn Investigational Site
Birmingham
California
Neuvosyn Investigational Site
Canoga Park
Neuvosyn Investigational Site
Greenbrae
Neuvosyn Investigational Site
Toluca Lake
Connecticut
Neuvosyn Investigational Site
Farmington
Florida
Neuvosyn Investigational Site
Boca Raton
Neuvosyn Investigational Site
Miami
Neuvosyn Investigational Site
Miami
Neuvosyn Investigational Site
Miami
Neuvosyn Investigational Site
Miami
Neuvosyn Investigational Site
Miami
Neuvosyn Investigational Site
Sunrise
Georgia
Neuvosyn Investigational Site
Acworth
Neuvosyn Investigational Site
Atlanta
Neuvosyn Investigational Site
Columbus
Neuvosyn Investigational Site
Sugar Hill
Michigan
Neuvosyn Investigational Site
Saginaw
Missouri
Neuvosyn Investigational Site
Gladstone
North Carolina
Neuvosyn Investigational Site
Denver
Neuvosyn Investigational Site
Winston-salem
New York
Neuvosyn Investigational Site
Williamsville
Ohio
Neuvosyn Investigational Site
Beavercreek
Neuvosyn Investigational Site
Columbus
Texas
Neuvosyn Investigational Site
Georgetown
Neuvosyn Investigational Site
Houston
Neuvosyn Investigational Site
Katy
Neuvosyn Investigational Site
Katy
Neuvosyn Investigational Site
Lewisville
Neuvosyn Investigational Site
Paris
Neuvosyn Investigational Site
Pearland
Neuvosyn Investigational Site
Stafford
Time Frame
Start Date: 2023-02-28
Completion Date: 2025-09-18
Participants
Target number of participants: 303
Treatments
Experimental: North Star
Active_comparator: Levothyroxine
Related Therapeutic Areas
Sponsors
Leads: Neuvosyn Laboratories, LLC