NCT04120363

Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations

A Randomized, Double-blind, Placebo Controlled Trial of Testosterone Undecanoate for Optimizing Physical and Cognitive Performance During Military Operations (OPS II)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to determine the effects of a single dose of testosterone undecanoate during and in recovery from simulated operational stress.

Detailed description

This is a double-blind, randomized, placebo controlled trial in 32 physically active men exposed to 20 complete days (days 8-27) of simulated operational stress followed by 20 complete days of recovery (days 29-48). After completing baseline testing (Phase 1), participants will be randomized to receive either a single intramuscular injection of testosterone undecanoate or an isovolumetric placebo (Day 8). The 20-day simulated operational stress (Phase 2) will be highly controlled (live-in study) and consist of 4 successive cycles of undulating stress, starting with 2 consecutive days of low stress followed by 3 consecutive days of high stress. Low- and high-stress days will result from low and high militarily-relevant exercise-induced energy expenditures, adequate and restricted sleep (8 hours vs. 4 hours daily), and diet restriction to produce energy deficits. After completing Phase 2, participants will be released to resume their habitual physical activity routines and will be provided a controlled diet to consume (Phase 3), to assess recovery from sustained, severe operational stress.

Conditions

• Caloric Restriction
• Exercise
• Sleep

Interventions

Type	Name	Description
DRUG	Testosterone Undecanoate	single intramuscular injection of 750 mg testosterone undecanoate
DRUG	Sesame Oil	single intramuscular injection of 750 mg sesame oil solution

Timeline

• Start date: 2019-09-23
• Primary completion: 2021-07-08
• Completion: 2021-07-08
• First posted: 2019-10-09
• Last updated: 2022-10-07
• Results posted: 2022-10-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study