NCT06188767

Brief Summary

The purpose of this project is to investigate underlying mechanisms of testosterone- and resistance training-induced muscle hypertrophy and muscle memory in humans.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
32mo left

Started Apr 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Apr 2025Dec 2028

First Submitted

Initial submission to the registry

December 18, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

2.7 years

First QC Date

December 18, 2023

Last Update Submit

April 7, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Fiber cross-sectional area

    Immunohistochemistry to determine fiber cross-sectional area

    The change in fiber cross-sectional is assessed at baseline, 4, 20 and 24 weeks

  • Myonuclei

    Immunohistochemistry to determine number of myonuclei

    The change in myonuclei is assessed at baseline, 4, 20 and 24 weeks

  • Skeletal muscle proteome

    Pathway enrichment analysis of the muscle proteome using mass spectrometry-based proteomics

    The change in the muscle proteome is assessed at baseline, 4, 20 and 24 weeks

Secondary Outcomes (3)

  • Lean mass

    The change in lean mass is assessed at baseline, 4, 20 and 24 weeks

  • Satellite cells

    The change in satellite cells is assessed at baseline, 4, 20 and 24 weeks

  • Muscle strength

    The change in 1-repetition maximum is assessed at baseline, 4, 20 and 24 weeks

Study Arms (2)

Testosterone

EXPERIMENTAL

Participants are randomized to a single injection of 1000 mg testosterone undecanoate

Drug: Testosterone Undecanoate

Placebo

PLACEBO COMPARATOR

Participants are randomized to a single placebo injection

Drug: Testosterone Undecanoate

Interventions

Following testosterone/placebo injection, participants undergo supervised resistance training for 4 weeks. This period is followed by a washout period with no drug and either continued resistance training or detraining for 16 weeks. Thereafter, another 4-week period with supervised resistance training is commenced, with no drug.

PlaceboTestosterone

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women
  • BMI of \<26 and normal ECG and blood pressure

You may not qualify if:

  • Smoking
  • Chronic disease,
  • Use of prescription medication
  • Pain due to current or previous musculoskeletal injury
  • Resistance training more than once per week in the 12 months leading up to the intervention
  • Current or previous use of prohibited anabolic substances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The August Krogh Section for Human and Molecular Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Interventions

testosterone undecanoate

Central Study Contacts

Lukas Moesgaard

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 3, 2024

Study Start

April 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

April 10, 2025

Record last verified: 2025-04

Locations