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Completed Phase 4 Interventional Results available

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

ClinicalTrials.gov ID: NCT04456296

Public ClinicalTrials.gov record NCT04456296. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 5:11 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04456296
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Enrollment
673 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2020 (Actual)
Primary completion
Jul 12, 2023 (Actual)
Completion
Jul 12, 2023 (Actual)
Last update posted
Mar 14, 2025

2020 – 2023

United States locations

U.S. sites
35
U.S. states
15
U.S. cities
30
Facility City State ZIP Site status
Endo Clinical Trial Site #8 Birmingham Alabama 35235 —
Endo Clinical Trial Site #22 Tucson Arizona 85712 —
Endo Clinical Trial Site #15 North Little Rock Arkansas 72116 —
Endo Clinical Trial Site #32 Bell Gardens California 90201 —
Endo Clinical Trial Site #33 Canoga Park California 91304 —
Endo Clinical Trial Site #30 Beverly Hills Florida 90211 —
Endo Clinical Trial Site #12 Boynton Beach Florida 33435 —
Endo Clinical Trial Site #34 Boynton Beach Florida 33435 —
Endo Clinical Trial Site #29 Fleming Island Florida 32003 —
Endo Clinical Trial Site #26 Miami Florida 33014 —
Endo Clinical Trial Site #2 Miami Florida 33014 —
Endo Clinical Trial Site #28 Miami Florida 33183 —
Endo Clinical Trial Site #10 Miami Beach Florida 33140 —
Endo Clinical Trial Site #18 Miami Gardens Florida 33023 —
Endo Clinical Trial Site #3 Oviedo Florida 32765 —
Endo Clinical Trial Site #4 Pembroke Pines Florida 33027 —
Endo Clinical Trial Site #11 Pompano Beach Florida 33060 —
Endo Clinical Trial Site #23 West Palm Beach Florida 33401 —
Endo Clinical Trial Site #16 Chicago Illinois 60611 —
Endo Clinical Trial Site #27 Glen Burnie Maryland 21061 —
Endo Clinical Trial Site #17 Towson Maryland 21204 —
Endo Clinical Trial Site #35 East Orange New Jersey 07018 —
Endo Clinical Trial Site #9 Garden City New York 11530 —
Endo Clinical Trial Site #7 New York New York 10016 —
Endo Clinical Trial Site #25 Winston-Salem North Carolina 27103 —
Endo Clinical Trial Site #5 Dayton Ohio 45417 —
Endo Clinical Trial Site #13 Bala-Cynwyd Pennsylvania 19004 —
Endo Clinical Trial Site #19 Houston Texas 77036 —
Endo Clinical Trial Site #31 Houston Texas 77084 —
Endo Clinical Trial Site #20 Houston Texas 77087 —
Endo Clinical Trial Site #21 Missouri City Texas 77459 —
Endo Clinical Trial Site #1 San Antonio Texas 78229 —
Endo Clinical Trial Site #14 Rutland Vermont 05701 —
Endo Clinical Trial Site #6 Charlottesville Virginia 22911 —
Endo Clinical Trial Site #24 Virginia Beach Virginia 23462 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04456296, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 14, 2025 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04456296 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →