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NCT03887936 · ClinicalTrials.gov registry record · Phase 4
Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism
A Phase 4 study of Type 2 Diabetes Mellitus and Hypogonadism, sponsored by VA Office of Research and Development.
- Active
- Registry status
- Phase 4
- Development phase
- 92
- Enrollment target
- 1
- Study location
NCT03887936: Active Phase 4 study of Type 2 Diabetes Mellitus and Hypogonadism, sponsored by VA Office of Research and Development.
NCT03887936 is a Phase 4 study of Type 2 Diabetes Mellitus and Hypogonadism that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 92 participants, below the 2,959-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03887936, a Phase 4 study of Type 2 Diabetes Mellitus and Hypogonadism, is active but no longer recruiting, sponsored by VA Office of Research and Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 92 participants
- Enrollment target
- 1
- Study location
Study Summary
Low testosterone and diabetes mellitus are each associated with increased risk for fractures. Men with diabetes mellitus are commonly found to have low testosterone as well. Testosterone has been shown to improve the bone health of patients with low testosterone but has not been tested in patients who also have diabetes mellitus in addition to low testosterone. To date, there is no treatment that is specifically recommended for bone disease among patients with diabetes. This study will evaluate the effect of testosterone on the bone health of male Veterans who have both diabetes and low testosterone, both of which are highly prevalent in this subset of the population.
Primary Outcome
The FEA (or FEA) is a surrogate measure of strength using computational biomechanical principles and integrate bone morphology and bone mass to calculate bone strength under various loading conditions normally seen in daily living activities. In addition, the ratio of load to strength can be calculated by using patient information (i.e. weight and height) and FEA derived bone strength to mechanistically simulate bone failure and thus, whether fracture is likely during a given activity. Using hig
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Testosterone gel 1.62%
Study Locations (1)
Texas
- Michael E. DeBakey VA Medical Center, Houston, TX - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 4 |
What the registry record for NCT03887936 still lists
NCT03887936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 2,959-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03887936 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03887936 about?
NCT03887936 is a clinical study titled "Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism". Low testosterone and diabetes mellitus are each associated with increased risk for fractures. Men with diabetes mellitus are commonly found to have low testosterone as well. Testosterone has been shown to improve the bone health of patients with low testosterone but has not been tested in patients w...
What is the current status of trial NCT03887936?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 92 participants. The study started on 2019-10-01. Estimated completion is 2026-06-30.
What conditions does trial NCT03887936 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus, Hypogonadism.
What interventions are being tested in trial NCT03887936?
The interventions under investigation include: Placebo (DRUG), Testosterone gel 1.62% (DRUG).
Who is sponsoring clinical trial NCT03887936?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03887936 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03887936's enrollment target sits among peer trials
92 57th of 130 higher than 74 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus 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.
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