Suncoast Clinical Research is seeking participants 18 – 75 years of age diagnosed with primary hypothyroidism to join a clinical trial study located at our office in New Port Richey.
Hypothyroidism
Age Range:
18 to 75
Gender:
Male and Female
Location:
New Port Richey
About the Study
The thyroid is a small, butterfly-shaped gland in the front of the neck that makes thyroid hormones (T4 and T3) that control the way the body uses energy. With hypothyroidism, or underactive thyroid, the thyroid gland does not produce enough thyroid hormones, which can lead to fatigue, weight gain, cold sensitivity, dry skin, and hair loss as well as neurological symptoms that can affect memory and mood.
The purpose of the AVANTI Study is to evaluate if an investigational medicine is safe and effective in the treatment of primary hypothyroidism. The study will compare the effect of the investigational medicine on primary hypothyroidism and its safety with Synthetic Drug T4 (Levothyroxine).
Participation in this study may last up to approximately 90 weeks and includes 3 treatment periods plus a screening and followup period.
If you qualify, investigational study medication(s) and care will be provided at no cost to you.
Qualifications
- Are 18 – 75 years of age
- Have been diagnosed with primary hypothyroidism for at least 12 months
- Have been on continuous thyroid replacement therapy with an FDA approved dose of synthetic T4 for at least 12 months, and at a stable dose for at least 3 months
- Have a BMI between 18 and 40
- Meet additional study criteria
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