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NCT04456296 · ClinicalTrials.gov registry record · Phase 4
A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
A Phase 4 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 673
- Enrollment target
NCT04456296: Completed Phase 4 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
NCT04456296 is a Phase 4 study that has completed, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 673 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04456296, a Phase 4 study, has completed, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 673 participants
- Enrollment target
Study 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.
Primary Outcome
The mean change from Baseline to EOS in 24-hour average systolic ambulatory blood pressure, for each treatment group was analyzed using an analysis of covariance (ANCOVA) model with treatment and study center (pooled centers) as fixed effects, Baseline 24-hour average systolic ambulatory blood pressure as covariate. EOS for the Aveed arm was Day 107 and EOS for Fortesta and Testim, was Day 114.
Interventions
- DRUG Fortesta
- DRUG Aveed Injectable Product
- DRUG Testim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 673 participants |
| Start Date | 2020-06-30 |
| Est. Completion | 2023-07-12 |
| Phase | Phase 4 |
What the finished NCT04456296 record still lists
NCT04456296 is an interventional study that assigns participants to a tested intervention. The registered 673 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (30% higher).
The record links to 0 conditions, and to 3 interventions - of which Fortesta is the first listed.
NCT04456296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04456296 about?
NCT04456296 is a clinical study titled "A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism". 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 ...
What is the current status of trial NCT04456296?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 673 participants. The study started on 2020-06-30. Estimated completion is 2023-07-12.
What interventions are being tested in trial NCT04456296?
The interventions under investigation include: Fortesta (DRUG), Aveed Injectable Product (DRUG), Testim (DRUG).
Who is sponsoring clinical trial NCT04456296?
This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04456296's enrollment target sits among peer trials
673 119th of 2000 higher than 1,882 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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