Trial · NCT00101361

Oxandrolone to Heal Pressure Ulcers

NCT00101361, Phase 3, Terminated, US Department of Veterans Affairs; results first posted 2013-11-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Oxandrolone to Heal Pressure Ulcers. Trials, record NCT00101361. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00101361

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Oxandrolone to Heal Pressure Ulcers
NCT number: NCT00101361
Status: Terminated
Phases: Phase 3
Enrollment: 212 participants, actual
Lead sponsor: US Department of Veterans Affairs
Conditions: Pressure Ulcer
Interventions: Oxandrolone, Placebo
First posted: 2005-01-10
Last updated: 2013-12-20
Results first posted: 2013-11-25
Limitations and caveats: Selection of severe wounds may have reduced treatment response. The study was terminated after a futility analysis showed a low probability of detecting a significant difference between groups.

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	A Healed Pressure Ulcer	healing was measured from randomization to full healing or 24 weeks, whichever occured first.	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.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	A Healed Pressure Ulcer	healing was measured from randomization to full healing or 24 weeks, whichever occured first.		participants	NUMBER

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
A Healed Pressure Ulcer	1 Oxandrolone		26		participants
A Healed Pressure Ulcer	2 Placebo		31		participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	1 Oxandrolone	108
Overall Study	STARTED	2 Placebo	104
Overall Study	COMPLETED	1 Oxandrolone	108
Overall Study	COMPLETED	2 Placebo	104
Overall Study	NOT COMPLETED	1 Oxandrolone	0
Overall Study	NOT COMPLETED	2 Placebo	0

Source ClinicalTrials.gov

Adverse events36

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	anemia	Blood and lymphatic system disorders	1 Oxandrolone	17	108	17
other	anemia	Blood and lymphatic system disorders	2 Placebo	4	104	4
other	constipation or diarrhea	Gastrointestinal disorders	1 Oxandrolone	8	108	8
other	constipation or diarrhea	Gastrointestinal disorders	2 Placebo	10	104	10
other	elevated liver enzyme levels	Investigations	1 Oxandrolone	35	108	35
other	elevated liver enzyme levels	Investigations	2 Placebo	3	104	3
other	fever	Injury, poisoning and procedural complications	1 Oxandrolone	17	108	17
other	fever	Injury, poisoning and procedural complications	2 Placebo	10	104	10
other	infection	Infections and infestations	1 Oxandrolone	13	108	13
other	infection	Infections and infestations	2 Placebo	9	104	9

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	1 Oxandrolone
Total, all-cause mortality	2 Placebo
Total, other adverse events	1 Oxandrolone	95	108
Total, other adverse events	2 Placebo	85	104
Total, serious adverse events	1 Oxandrolone	9	108
Total, serious adverse events	2 Placebo	16	104

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23689765	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
1 Oxandrolone vs 2 Placebo: A Healed Pressure Ulcer	Trial comparisons
1 Oxandrolone vs 2 Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00101361

GET https://conductscience.org/api/trials/v1/NCT00101361/events?page=2

API reference For AI assistants