Summary:
This study is designed to evaluate the effect on blood pressure of approved testosterone products (Testim®, Fortesta®, and Aveed®) after 16 weeks of therapy using 24-hour ambulatory blood pressure to reveal shifts in blood pressure levels.
- Be 18 years and older
- Have a diagnosis of primary hypogonadism or hypogonadotropic hypogonadism
- Have a total serum testosterone at screening < 300 ng/dL based on 2 blood samples obtained at 10 am (+/-2 hours) on 2 separate occasions at least 48 hours apart
- Be naïve to androgen replacement or washout of 12 weeks following intramuscular androgen injections; 4 weeks following topical or buccal, nasal, or oral androgens.
- Have a screening blood pressure at rest of less than 140 millimeters of mercury (mm Hg) for systolic blood pressure and less than 90 mm Hg for diastolic blood pressure.
- Be judged to be in good health.
- Participants enrolled in the Testim or Fortesta treatment arms: take necessary precautions to avoid skin-to-skin contact and potential transfer and if male use effective contraception.
- Be willing and able to cooperate with the requirements of the study.
Qualified Participants May Receive:
• No-cost study medication
• No-cost study-related care from a local doctor
• Compensation