A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
Status:
Recruiting
Trial end date:
2022-12-07
Target enrollment:
Participant gender:
Summary
Testosterone is the principal androgen produced by the male testes. Hypogonadism is the
result of inadequate production of testosterone by the Leydig cells of the testes and is
reflected by total serum concentrations of testosterone of < 300 ng/dL, with discernible
diurnal pattern. The etiology of hypogonadism may be primary or secondary. The treatment of
males with primary, and in some cases, secondary Hypogonadism includes administration of
testosterone.
Testim® and Fortesta® are topical gels that when applied daily help to increase the total
testosterone levels in the blood through skin absorption. Aveed® is an injectable form of
testosterone treatment and participants randomized to this treatment arm will receive 3
injections over the course of 16 weeks.
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 (ABPM) to reveal shifts in BP levels.