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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.