A Study Evaluation the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Patients With Primary Hypothyroidism
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Neuvosyn Laboratories, LLC
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation or excretion of North Star or levothyroxine
Hospitalization for a major illness within 4 weeks prior to Screening
Anticipated initiation or change in concomitant medications
Concomitant use of prohibited medications or supplements
Participated in another investigational new drug study within 30 days or 5 half-lives of the IMP, whichever is longer, prior to the first study drug administration.
For female subjects, be pregnant, nursing or planning to become pregnant during the study
Clareo Health | A Study Evaluation the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Patients With Primary Hypothyroidism
