NCT04120363 (OPS II) is a Phase 4 clinical trial of Testosterone Undecanoate in Caloric Restriction, sponsored by Pennington Biomedical Research Center.

Who is sponsoring NCT04120363?

NCT04120363 is sponsored by Pennington Biomedical Research Center.

What drugs are being tested in NCT04120363?

Interventions in NCT04120363: Testosterone Undecanoate, Sesame Oil.

What condition does NCT04120363 study?

NCT04120363 studies Caloric Restriction, Exercise, Sleep.

Is NCT04120363 still recruiting?

NCT04120363 is currently completed. Last updated 7 October 2022.

Are results published for NCT04120363?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-10-07 · How we verify

NCT04120363: OPS II

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations

Completed Phase 4 Results posted Last updated 7 October 2022

What this trial tests

Phase 4 trial testing Testosterone Undecanoate in Caloric Restriction in 34 participants. Completed in 8 July 2021.

Timeline

23 September 2019

Primary endpoint
8 July 2021

8 July 2021

Quick facts

Lead sponsor	Pennington Biomedical Research Center
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	34
Start date	23 September 2019
Primary completion	8 July 2021
Estimated completion	8 July 2021
Sites	1 location across United States

Drugs / interventions tested

Testosterone Undecanoate (TESTOSTERONE UNDECANOATE) — full drug profile →
Sesame Oil — full drug profile →

Conditions studied

Caloric Restriction — all drugs for Caloric Restriction →
Exercise — all drugs for Exercise →
Sleep — all drugs for Sleep →

Sponsor

Pennington Biomedical Research Center — full company profile →

Who can join

Adults 18 to 35, male only, with Caloric Restriction or Exercise. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Load Carriage Time Primary · Day 5 (Phase 1), Day 26 (Phase 2), Day 47 (Phase 3)

A load carriage time trial (a militarily relevant aerobic performance assessment) was conducted near the end of each study phase to assess aerobic performance.

2.5 mile time, Phase 1

Group	Value	95% CI
Testosterone	45.21	± 2.01
Placebo	41.58	± 1.94

2.5 mile time, Phase 2

Group	Value	95% CI
Testosterone	50.95	± 2.01
Placebo	47.15	± 1.99

2.5 mile time, Phase 3

Group	Value	95% CI
Testosterone	44.31	± 2.07
Placebo	39.34	± 2.12

Body Composition Secondary · Day 7 (Phase 1), Day 28 (Phase 2), Day 49 (Phase 3)

A four-compartment (4C) model factoring in body mass, body volume, total body water, and bone mineral content was used to calculate fat-free body mass and fat mass at the end of each study phase.

Fat-free Mass at end of Phase 1

Group	Value	95% CI
Testosterone	59.2	± 2.0
Placebo	59.8	± 2.1

Fat-free Mass at end of Phase 2

Group	Value	95% CI
Testosterone	59.6	± 2.0
Placebo	57.9	± 2.1

Fat-free Mass at end of Phase 3

Group	Value	95% CI
Testosterone	59.5	± 2.0
Placebo	59.6	± 2.1

Fat Mass at end of Phase 1

Group	Value	95% CI
Testosterone	17.3	± 1.5
Placebo	17.5	± 1.6

Fat Mass at end of Phase 2

Group	Value	95% CI
Testosterone	13.0	± 1.5
Placebo	14.4	± 1.6

Fat Mass at end of Phase 3

Group	Value	95% CI
Testosterone	15.1	± 1.5
Placebo	15.5	± 1.6

Vertical Jump Height Primary · Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)

Lower-body peak power was assessed near the end of each phase using a vertical jump test.

Vertical Jump Height, Phase 1

Group	Value	95% CI
Testosterone	54.5	± 2.5
Placebo	53.6	± 2.4

Vertical Jump Height, Phase 2

Group	Value	95% CI
Testosterone	49.1	± 2.5
Placebo	50.0	± 2.5

Vertical Jump Height, Phase 3

Group	Value	95% CI
Testosterone	54.0	± 2.5
Placebo	50.5	± 2.5

Total Mass Lifted Primary · Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)

A 3-repetition maximum deadlift assessed muscular strength, endurance, and explosive power near the end of each study phase.

Total Mass Lifted, Phase 1

Group	Value	95% CI
Testosterone	127.4	± 7.4
Placebo	127.9	± 7.0

Total Mass Lifted, Phase 2

Group	Value	95% CI
Testosterone	122.7	± 7.4
Placebo	119.0	± 7.2

Total Mass Lifted, Phase 3

Group	Value	95% CI
Testosterone	126.7	± 7.7
Placebo	129.8	± 7.2

Wingate Peak Power Primary · Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)

Anaerobic capacity was assessed using a Wingate anaerobic cycle test near the end of each study phase.

Wingate peak power, absolute, Phase 1

Group	Value	95% CI
Testosterone	879.4	± 49.6
Placebo	837.8	± 49.6

Wingate peak power, absolute, Phase 2

Group	Value	95% CI
Testosterone	753.8	± 49.6
Placebo	736.0	± 49.6

Wingate peak power, absolute, Phase 3

Group	Value	95% CI
Testosterone	821.8	± 49.6
Placebo	790.8	± 49.6

Peak Aerobic Capacity Primary · Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)

Peak aerobic capacity was measured via treadmill VO2peak near the end of each study phase.

VO2peak, absolute, Phase 1

Group	Value	95% CI
Testosterone	3.22	± 0.15
Placebo	3.28	± 0.14

VO2peak, absolute, Phase 2

Group	Value	95% CI
Testosterone	3.13	± 0.15
Placebo	3.20	± 0.14

VO2peak, absolute, Phase 3

Group	Value	95% CI
Testosterone	3.29	± 0.15
Placebo	3.44	± 0.14

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Testosterone

Serious: 0/16 (0%)

Deaths: 0/16

Placebo

Serious: 0/18 (0%)

Deaths: 0/18

Other adverse events (10 terms — click to expand)

Reaction	System	Testosterone	Placebo
Musculoskeletal issues	Musculoskeletal and connective tissue disorders	—	—
Dermatologic issues	Skin and subcutaneous tissue disorders	—	—
Gastrointestinal issues	Gastrointestinal disorders	—	—
Nonspecific issues	General disorders	—	—
Neurological issues	Nervous system disorders	—	—
Respiratory issues	Respiratory, thoracic and mediastinal disorders	—	—
Oral complaints	General disorders	—	—
Special senses issues	General disorders	—	—
Cardiovascular issues	Vascular disorders	—	—
Genitourinary issues	Renal and urinary disorders	—	—

Data from ClinicalTrials.gov NCT04120363 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Monitoring body composition change for intervention studies with advancing 3D optical imaging technology in comparison to dual-energy X-ray absorptiometry.
Wong MC, Bennett JP, Leong LT, Tian IY, et al · · 2023 · cited 19× · PMID 36796647 · DOI 10.1016/j.ajcnut.2023.02.006
Testosterone undecanoate administration prevents declines in fat-free mass but not physical performance during simulated multi-stressor military operations.
Varanoske AN, Harris MN, Hebert C, Howard EE, et al · · 2022 · cited 8× · PMID 35796614 · DOI 10.1152/japplphysiol.00190.2022
Effects of testosterone undecanoate on performance during multi-stressor military operations: A trial protocol for the Optimizing Performance for Soldiers II study.
Varanoske AN, Harris MN, Hebert C, Howard EE, et al · · 2021 · cited 4× · PMID 34278044 · DOI 10.1016/j.conctc.2021.100819
Bioelectrical impedance phase angle is associated with physical performance before but not after simulated multi-stressor military operations.
Varanoske AN, Harris MN, Hebert C, Johannsen NM, et al · · 2023 · cited 2× · PMID 36949577 · DOI 10.14814/phy2.15649
Exercise Heart Rate Variability Suggests Parasympathetic Hyperactivity during Simulated Military Operations Irrespective of Testosterone Administration.
Lowe AC, Niclou A, Varanoske AN, Harris MN, et al · · 2025 · cited 1× · PMID 40279652 · DOI 10.1249/mss.0000000000003743

Verify or expand the search:

Other trials of Testosterone Undecanoate

Trials testing the same drug.

NCT06188767 — Testosterone-induced Muscle Memory and Underlying Mechanisms · NA · recruiting
NCT05964920 — Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone? · Phase 2, PHASE3 · completed
NCT05081193 — Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrat · Phase 2 · completed
NCT05541172 — Testosterone Undecanoate Replacement Therapy in Boys With Pubertal Delay or Confirmed Hypogonadism · unknown
NCT06489457 — The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With · Phase 3 · completed

Other recruiting trials for Caloric Restriction

Currently open trials in the same condition.

NCT07499167 — BRAHMS: Bed Rest And HypoMetabolism Study · NA · recruiting
NCT07272343 — The Impact of Semaglutide Compared to Energy Restriction on Type 2 Diabetes · Phase 4 · recruiting

Other Pennington Biomedical Research Center trials

Trials by the same sponsor.

NCT07530718 — Body Composition Outcomes in MS Patients · not yet recruiting
NCT07095972 — Continuous Glucose Monitoring in Metabolic Surgery · NA · not yet recruiting
NCT07139821 — Dietary Iron Requirements · recruiting
NCT07318064 — Ultra-processed Food Consumption and Health Pilot Study · NA · not yet recruiting
NCT07305753 — CanCan Body Composition Study · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04120363 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pennington Biomedical Research Center
Last refreshed: 7 October 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04120363.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing