drugset / Trial / NCT05516849
Placebo Versus Oxandrolone Supplementation in Trauma
Phase 3
Withdrawn
Sunnybrook Health Sciences Centre
United States Department of Defense · collabWalter Reed National Military Medical Center · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary aim of this study is to examine the effect of Oxandrolone supplementation after lower extremity high energy fracture on muscle volume recovery. As Oxandrolone supplementation has never been examined in this patient population, the primary null hypothesis is that there will be no difference in measured thigh muscle mass volume between Oxandrolone supplementation and placebo administration groups.
Timeline
- Start
- 2022-05-19
- Primary completion
- 2023-08-03
- Completion
- 2023-08-03
Outcome
Outcome not reported
Stopped (Business): “FDA requested manufacturers of Oxandrolone Tablets, to voluntarily remove previously approved drug applications for Oxandrolone from the U.S. market \& the funding decided to prematurely terminate the funding.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxandrolone | Small molecule | — | — |
Indications
No indication recorded.