Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Neuvosyn Laboratories, LLC
An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets for the Treatment of Primary Hypothyroidism
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosed with primary hypothyroidism, including Hashimoto's Thyroiditis, and on therapy with a stable dose of LT4 (minimum 50 mcg per day, administered 7 days per week) for at least 12 weeks prior to Screening
Have had euthyroid status for at least 6 weeks and up to 12 months prior to Screening (Visit 1), with at least one documented minimum stable dose of 50 mcg LT4.
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
Hospitalization for a major illness within 5 weeks prior to Screening
Concomitant use of prohibited medications or supplements
Have uncontrolled diabetes
Taking or having taken prescription or over-the-counter weight loss medications within 6 weeks prior to Screening
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
