NCT04456296

A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism

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 Treatment With Marketed Testosterone Products

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 673 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Testosterone is the principal androgen produced by the male testes. Male 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 no 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.

Conditions

• Hypogonadism
• Hypogonadism, Male
• Hypogonadotropic Hypogonadism

Interventions

Type	Name	Description
DRUG	Aveed Injectable Product	Testosterone undecanoate administered by intramuscular injections.
DRUG	Fortesta	Testosterone gel administered topically. The daily dose of the study drug will be titrated for each participant, according to approved dosage and administration instructions, until the circulating testosterone concentrations of the participant reaches normal concentrations (300-1000 ng/dL).
DRUG	Testim	Testosterone gel administered topically. The daily dose of the study drug will be titrated for each participant, according to approved dosage and administration instructions, until the circulating testosterone concentrations of the participant reaches normal concentrations (300-1000 ng/dL).

Timeline

• Start date: 2020-06-30
• Primary completion: 2023-07-12
• Completion: 2023-07-12
• First posted: 2020-07-02
• Last updated: 2025-03-14
• Results posted: 2025-03-14

Locations

35 sites across 1 country: United States

Regulatory

• FDA-regulated drug study