Nasal Testosterone Gel for Men
Protocol: STUDY00005695
Full Title
24-hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Treated with Natesto Nasal Testosterone Gel
This study will measure the change in blood pressure following 4 months of testosterone therapy with Natesto. A total of 218 subjects with a diagnosis of hypogonadism who successfully complete the 24-hour baseline blood pressure session will be included in the study. The total duration of study will be approximately 4 months. Compensation / Reimbursement to study participants.
Compensation: Yes
Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
1. Male between 18 and 80 years of age, inclusive, with documented onset of hypogonadism prior to age 65. 2. Serum total testosterone < 300 ng/dL based on 2 consecutive blood samples obtained no greater than 1-4 weeks apart between 6 and 10 AM following an appropriate washout of current androgen replacement therapy if not testosterone naive. Historical values from the past 6 months may be used. 3. Testosterone Therapy naïve, OR off any testosterone therapy for at least 4 months OR agree to a 4-month washout of current testosterone therapy prior to entry at Visit 1. 4. Average office blood pressure measurement <140 mmHg SBP -AND- <90 mmHg DBP. Two readings should be taken at least 2 minutes apart and averaged. If the two readings are more than 20 mmHg SBP and/or 10 mmHg DBP apart, a third reading should be taken (minimally 2 minutes from the last one) and included in the average. 5. If the patient is on an antihypertensive regimen, he has been on it for at least 4 weeks.
Age Group: Adults
Principal Investigator: AJAY CHAUDHURI
Arsalan Mustafa
+1 716-548-9493
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