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A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism

S

Sention Therapeutics

Status and phase

Completed
Phase 2

Conditions

Hypothyroidism

Treatments

Drug: Levothyroxine
Drug: ST-1891

Study type

Interventional

Funder types

Industry

Identifiers

NCT05412979
ST-1891-201

Details and patient eligibility

About

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.

Enrollment

490 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

490 participants in 2 patient groups

ST-1891
Experimental group
Treatment:
Drug: ST-1891
Levothyroxine
Active Comparator group
Treatment:
Drug: Levothyroxine

Trial contacts and locations

39

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Data sourced from clinicaltrials.gov

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