A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared t… (NCT05412979) | Clinical Trial Compass
CompletedPhase 2
A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism
United States490 participantsStarted 2022-04-29
Plain-language 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 patients with primary hypothyroidism.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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