Status:
COMPLETED
A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism
Lead Sponsor:
Sention Therapeutics, LLC
Conditions:
Hypothyroidism
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
ST-1891-201 is a multicenter, randomized, double-blind, partial crossover, Phase 2 study evaluating the safety and efficacy of hormone replacement therapy with ST-1891 compared to levothyroxine in pat...
Eligibility Criteria
Inclusion
- Diagnosed with primary hypothyroidism
- On continuous thyroid replacement therapy with levothyroxine for at least 12 months immediately prior to Screening
- On a stable daily dose of levothyroxine for the 3 months prior to Screening
- Willing to give written informed consent for the Study
Exclusion
- Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation or excretion of ST-1891 or levothyroxine
- Female patients who are pregnant or are breastfeeding starting 30 days prior to Screening
- Anticipated initiation or change in concomitant medications
- Concomitant use of prohibited medications
- Currently participating in another clinical study or have received active treatment with an investigational drug within 30 days or 5 half-lives of the investigational drug of Screening, whichever is longer
Key Trial Info
Start Date :
April 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2023
Estimated Enrollment :
490 Patients enrolled
Trial Details
Trial ID
NCT05412979
Start Date
April 29 2022
End Date
October 4 2023
Last Update
August 26 2024
Active Locations (39)
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1
Sention Investigational Site
Greenbrae, California, United States, 94904
2
Sention Investigational Site
Newhall, California, United States, 91321
3
Sention Investigational Site
Denver, Colorado, United States, 80246
4
Sention Investigational Site
Fort Lauderdale, Florida, United States, 33312