Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00101361 · ClinicalTrials.gov registry record · Phase 3
Oxandrolone to Heal Pressure Ulcers
A Phase 3 study, sponsored by US Department of Veterans Affairs.
- Terminated
- Registry status
- Phase 3
- Development phase
- 212
- Enrollment target
NCT00101361: Clinical Trial Phase 3 study, sponsored by US Department of Veterans Affairs.
NCT00101361 is a Phase 3 study that was terminated before completion, run by US Department of Veterans Affairs. The registered enrollment target is 212 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00101361, a Phase 3 study, was terminated before completion, sponsored by US Department of Veterans Affairs.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 212 participants
- Enrollment target
Study Summary
This study is designed to determine whether the use of oxandrolone, an anabolic steroid, can heal pressure ulcers in persons with spinal cord injury (SCI). In a Feasibility Study, three VA SCI Units will screen and randomize patients into treatment with oxandrolone or with placebo. Eleven other sites will screen patients to determine eligibility but will not treat patients with the agent. Following the Feasibility Study, all sites will participate in a blinded, randomized treatment study. A total of 400 patients will be enrolled over a four-year period. Any patient in a participating unit who has chronic SCI and a difficult-to-heal pelvic ulcer will be eligible for the study if other entry criteria are met. All enrolled patients will be followed for a period of 24 weeks to determine whether their target pressure ulcers heal. Those who are healed will be followed for an additional four weeks to determine whether the ulcer remains healed.
Primary Outcome
Patients remained in treatment until full healing of the target pressure ulcer (defined as re-epithelialization to a cicatrix with a dry surface and zero open area for a minimum of 96 hours) or 24 weeks, whichever occured first.
Interventions
- DRUG Placebo
- DRUG Oxandrolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2005-08 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
Why NCT00101361 stopped before completion
NCT00101361 is an interventional study that assigns participants to a tested intervention. The registered 212 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00101361 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00101361 about?
NCT00101361 is a clinical study titled "Oxandrolone to Heal Pressure Ulcers". This study is designed to determine whether the use of oxandrolone, an anabolic steroid, can heal pressure ulcers in persons with spinal cord injury (SCI). In a Feasibility Study, three VA SCI Units will screen and randomize patients into treatment with oxandrolone or with placebo. Eleven other site...
What is the current status of trial NCT00101361?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 212 participants. The study started on 2005-08. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00101361?
The interventions under investigation include: Placebo (DRUG), Oxandrolone (DRUG).
Who is sponsoring clinical trial NCT00101361?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00101361's enrollment target sits among peer trials
212 1335th of 2000 higher than 664 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04228978 · 212 participants · NA
Promote Weight Loss in Obese Peripheral Artery Disease (PAD) Patients to Prevent Mobility Loss
- NCT04725721 · 212 participants · NA
Testing FIRST in Youth Outpatient Psychotherapy
- NCT06257576 · 212 participants · Phase 3
Function of Tamsulosin in Older Males Undergoing Surgery with Indwelling Catheter
- NCT06456593 · 212 participants · Phase 2
Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia