An Open-Label, Randomized, Parallel-Group, Three Treatment Arm, Multicenter Study on Hypogonadal Males to Evaluate the Effect on 24-Hour Ambulatory Blood Pressure After 16-Week Continuous Administration With Marketed Testosterone Products

  • STATUS
    Recruiting
  • participants needed
    618
  • sponsor
    Endo Pharmaceuticals
Updated on 9 December 2022
androgens
replacement therapy
testosterone
testosterone level
serum testosterone
hypogonadism
diastolic blood pressure
testosterone gel
hypogonadotropic hypogonadism
klinefelter syndrome
secondary hypogonadism
testim
screening procedure
aveed injectable product
fortesta

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 nanograms (ng)/deciliters (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 to reveal shifts in blood pressure levels.

Details
Condition Hypogonadism, Hypogonadism, Male, Hypogonadotropic Hypogonadism
Treatment Aveed Injectable Product, Fortesta or Testim, Aveed Injectable Product, Aveed Injectable Product, Fortesta, Fortesta, Testim, Testim
Clinical Study IdentifierNCT04456296
SponsorEndo Pharmaceuticals
Last Modified on9 December 2022

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