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Terminated Phase 3 Interventional Results available

Oxandrolone to Heal Pressure Ulcers

ClinicalTrials.gov ID: NCT00101361

Public ClinicalTrials.gov record NCT00101361. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 4:26 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

CSP #535 - Anabolic Steroid Therapy on Pressure Ulcer Healing in Persons With Spinal Cord Injury

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00101361
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Enrollment
212 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2005 (Type not available)
Primary completion
Dec 2008 (Actual)
Completion
Dec 2008 (Actual)
Last update posted
Dec 20, 2013

2005 – 2008

United States locations

U.S. sites
15
U.S. states
11
U.S. cities
15
Facility City State ZIP Site status
VA Medical Center, Long Beach Long Beach California 90822 —
VA Palo Alto Health Care System Palo Alto California 94304-1290 —
VA San Diego Healthcare System, San Diego San Diego California 92161 —
VA Medical Center, Miami Miami Florida 33125 —
James A. Haley Veterans Hospital, Tampa Tampa Florida 33612 —
VA Medical Center, Augusta Augusta Georgia 30904 —
Edward Hines, Jr. VA Hospital Hines Illinois 60141-5000 —
VA Boston Healthcare System, Brockton Campus Brockton Massachusetts 02301 —
VA Medical Center, St Louis St Louis Missouri 63106 —
VA Medical Center, Bronx The Bronx New York 10468 —
VA Medical Center, Cleveland Cleveland Ohio 44106 —
VA North Texas Health Care System, Dallas Dallas Texas 75216 —
Michael E. DeBakey VA Medical Center (152) Houston Texas 77030 —
Hunter Holmes McGuire VA Medical Center Richmond Virginia 23249 —
Zablocki VA Medical Center, Milwaukee Milwaukee Wisconsin 53295-1000 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00101361, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 20, 2013 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00101361 live on ClinicalTrials.gov.

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