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Androgen

Testosterone injection and Medrol 6 day dose pack for Sarcopenia

Phase 4
Waitlist Available
Led By Randall J Urban, M.D.
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study days -7 to -1 (pre - treatment)
Awards & highlights

Summary

Skeletal muscle loss is a common consequence of aging and in some individuals reaches a level that compromises health and quality of life. Age-associated increases in cytokine and inflammatory signaling may be important contributors to this process. The investigators will assess the practical question of whether testosterone injection and gel application elicit similar responses. Resistance exercise will be used as a means of stimulating both inflammatory and anabolic responses in skeletal muscle. In order to assess the effects of testosterone on these responses, subjects will perform resistance exercise on two occasions separated by 7 days. The first session will be performed prior to the initiation of testosterone and/or medrol therapy and the second session will be performed after receiving therapy for 7 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study days -7 to -1 (pre - treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and study days -7 to -1 (pre - treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)
C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)
Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol
+37 more

Trial Design

4Treatment groups
Active Control
Group I: Testosterone injection and Medrol 6 day dose packActive Control2 Interventions
Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.
Group II: Medrol 6 day dose packActive Control1 Intervention
Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.
Group III: Testosterone injectionActive Control1 Intervention
Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection
Group IV: Testosterone gelActive Control1 Intervention
Testosterone topical gel (Androgel 1%) 10 mg administered daily for seven days

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
246 Previous Clinical Trials
56,771 Total Patients Enrolled
9 Trials studying Sarcopenia
727 Patients Enrolled for Sarcopenia
Randall J Urban, M.D.Principal InvestigatorThe University of Texas Medical Branch at Galveston
2 Previous Clinical Trials
41 Total Patients Enrolled
~2 spots leftby Aug 2025