Musculoskeletal InjuryPhase 4ARMORNCT06455969
Adaptions and Resiliency to Multi-Stressor OpeRations
A Phase 4 study testing Goserelin 3.6 MG, Multi-Stressor Training and Testosterone gel (AndroGel 5g) in people with Musculoskeletal Injury and Hypogonadism, run by Bradley Nindl at 1 site in United States.
Trial summary
Non-combat-related muscle, tendon and bone injuries are the most common injuries suffered by military personnel, particularly in new recruits. These injuries impact military readiness and are responsible for roughly 60% of limited duty days, 65% of soldiers who are unable to deploy, and nearly $500 million in medical… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Injury, Hypogonadism, Hormonal Contraception
- What is being tested?
- Goserelin 3.6 MG, Multi-Stressor Training and Testosterone gel (AndroGel 5g)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2024to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40 years
- body mass index (BMI) 18-30 kg/m2
- weight stable (±10 lbs) in past 2 months
- takes part in moderate physical activity for at least 150 minutes/week
- currently free of upper or lower body /extremity injury or impairment
- able to commit to study duration
Show all 12Show fewer
- agrees to adhere to study requirements
- not taking prescription medications or be willing to refrain from medication prior to and throughout the study period, unless approved by study physician
- in women, eumenorrheic (cycles of 26-35 days) OR using monophasic oral contraceptive pills with norethindrone acetate (e.g., first generation progestin) for previous 3 months
- 1) Current smoker 2) current clinical diagnosis of an eating disorder 3) use of medication incompatible with measurement of reproductive and metabolic hormones or which may interfere with any of the study outcomes; with the exception of approved contraceptives for the contraceptive STRESS \& CONTROL groups 4) current oligo/amenorrhea in women 5) any metabolic or endocrine disease 6) has been diagnosed with a medical condition, physical or psychological, that currently prevents potential subjects from exercising 7) currently pregnant or becomes pregnant during the study 8) history of heart condition OR high blood pressure 9) treating physician requires subject participates in medically supervised physical activity only 10) history of drug addiction, or regular use of recreational drugs 11) currently undergoing treatment for or have a history of mental health conditions 12) Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, Cushing's, diabetes mellitus or renal insufficiency 13) Current use of medications known to affect bone metabolism including estrogens, androgens, anti-estrogens, bisphosphonates (oral bisphosphonates within one year of the baseline visit or IV bisphosphonates within three years of the baseline visit), calcitonin, fluoride, oral or inhaled glucocorticoids, suppressive doses of thyroxine, lithium, pharmacological doses of vitamin D (greater than 2000 IU/day), anti-convulsants, depot medroxyprogesterone within 6 months; with the exception of approved contraceptives for the contraceptive STRESS \& CONTROL groups 14) History of deep vein thrombosis, pulmonary embolism, or clotting disorders. 15) History of stroke or myocardial infarction 16) Fracture within the last 6 months. 17) Systolic blood pressure > 160 or diastolic blood pressure > 95 18) Active substance abuse 19) History of hereditary angioedema 20) History of chest pain at rest, during daily activities of living, or when performing physical activity 21) Musculoskeletal injury removing subject from physical activity for more than a month within the past 2 years 22) Recreational drug use more than 2 times per month in each of the previous 6 months 23) Self-reported vision is worse than 20/20. 24) Personal history or history of a first-degree relative with breast cancer 25) Participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration 26) Diagnosed with eating disorder 27) Have food allergies, intolerance, restriction, or special diet needs 28) History of endometriosis 29) Current diagnosis of reproductive health issues, such as ovarian cysts, PCOS, pelvic lesions, undiagnosed ovarian enlargement 30) Have undiagnosed abnormal vaginal bleeding 31) Currently breastfeeding or within 2 months after stopping breastfeeding 32) Frequent headaches accompanied by vision changes (indicative of possible pituitary pathology)
- For SUPPRESS and REPLACE:
- 1-32 listed above 33) PSA >3 ng/mL) 34) Serum 25-hydroxyvitamin D < 20 ng/mL 35) Thyroid dysfunction 36) Serum creatinine > 2 mg/dL 37) Personal history or history of a first-degree relative with breast cancer 38) Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2x the upper limit of normal 39) Serum bilirubin > 2 mg/dL 40) Serum alkaline phosphatase > 150 U/L 41) Plasma hemoglobin < 10 gm/dL 42) Hematocrit > 50 43) In men, Serum testosterone level < 270 or > 1070 ng/dL (< 9 or > 37 nmol/ L) 44) Triglycerides > 150 fasting
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Neuromuscular Research Laboratory
Pittsburgh, Pennsylvania, 15203
Brian J Martin, PhD, 412-246-0460, bjm135@pitt.edu
About this study
Official title: Musculoskeletal Resiliency and Adaptation to Sex Steroid Suppression and Replacement During Multi-Stressor Training
Non-combat-related muscle, tendon and bone injuries are the most common injuries suffered by military personnel, particularly in new recruits. These injuries impact military readiness and are responsible for roughly 60% of limited duty days, 65% of soldiers who are unable to deploy, and nearly $500 million in medical cost to the government annually in the Army alone. Drug interventions must be studied and developed to prevent these negative outcomes and prepare military personnel for the demands of military service. At the current time, military leadership has identified critical gaps in understanding how to minimize these injuries and train soldiers with drug intervention serving among those gaps.
The goal of this study is to determine how a hormonal intervention can change muscle, tendon, and bone function as well as physical and psychological performance in response to mental and physical stress. To do so, we will examine sex hormone (testosterone, estrogen) levels, muscle, tendon, and bone images, blood samples, and physical and mental performance. We will look at things like changes in hormone levels, chemicals released from active skeletal muscles, and your body composition. The results from this study will be used to improve physical readiness training in the military with the goal of reducing injuries.
Read the detailed description
Suppression of the reproductive hypothalamic-pituitary-gonadal (HPG) axis is a common physiological response to strenuous military training and can be difficult to replicate in simulated environments. Additionally, whether HPG suppression (through pharmacological suppression or hormonal contraceptive use) contributes to the physiological changes, performance decrements, and high MSK injury risk associated with multi-stressor military training is unknown. Thus, we will 1) utilize pharmacological inhibition of the HPG axis to test if testosterone replacement in men will mitigate injury risk and performance decrements following military-relevant multi-stressor training and 2) investigate how hormonal contraceptive use in women may impact these outcomes. This project aims to deliver a state-of-the-art evaluation of male and female adaptive responses to multi-stressor training and evidence-based guidance for the safe and ethical use of exogenous hormone replacement as a MSK injury mitigation solution during multi-stressor training and operations.
- Conditions
- Musculoskeletal Injury, Hypogonadism, Hormonal Contraception
- Being tested
- Goserelin 3.6 MG, Multi-Stressor Training, Testosterone gel (AndroGel 5g), Testosterone gel (AndroGel 1.25g)
- Keywords
- Military, Multi-stressor Training, Tendon, Muscle, Bone
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goserelin 3.6 MGDrug
Also called Zoladex
Goserelin acetate (Zoladex) is a gonadotropin-releasing hormone agonist (GnRH). GnRH agonists induce a transient increase in sex hormone concentrations, but subsequently inhibit gonadotropin secretion and the production of testosterone in men and estrogen in women. An equilibration period will occur to allow steroid concentrations to reduce.
Multi-Stressor TrainingOther
A 4-week physical training program that mimics military training.
Testosterone gel (AndroGel 5g)Drug
Male subjects will be randomly assigned to receive a topical testosterone gel (5g dose).
Testosterone gel (AndroGel 1.25g)Drug
Male subjects will be randomly assigned to receive a topical testosterone gel (1.25g dose).
| Study group | Role | What they receive |
|---|---|---|
| CONTROL (men + women) | No intervention | The control group will maintain their habitual exercise, diet, and sleep patterns, all of which will be monitored throughout the study. |
| STRESS (men + women): Multi-Stressor Training | Active comparator | Research volunteers will be randomized into the stress exposure group (STRESS) will undergo a 4-week exercise training program consisting of 5 consecutive days of strenuous physical training followed by 2 days of recovery (energy balance, no structured exercise). The exercise training program will consist of military-relevant physical training exercises (e.g., load carriage, aerobic and resistance exercises) that progressively increase in duration and intensity to increase exercise energy expenditure. Participants will perform multiple exercises per day using a variety of endurance and muscle loading modalities designed to mimic movements typically observed during real-life military operations. Receives: Other: Multi-Stressor Training |
| SUPPRESS (men): Multi-Stressor Training + Zoladex + AndroGel 1.25g | Experimental | In addition to participating in the multi-stressor training program, male participants randomized to the GnRH suppressed (SUPPRESS) group will be administered a long-acting GnRH agonist (Zoladex) by trained medical professionals to suppress endogenous gonadal steroids. Following GnRH agonist administration, men will be administered 1.25g/day (SUPPRESS) of topical 1% testosterone gel (AndroGel, Abbvie, North Chicago, IL) to be applied to the shoulders, upper arms, and/or stomach area daily. Receives: Drug: Goserelin 3.6 MG; Other: Multi-Stressor Training; Drug: Testosterone gel (AndroGel 1.25g) |
| Hormonal Contraceptive Use (women): Multi-stressor training + Hormonal Contraceptive Use | Active comparator | Female participants who report that they are currently using hormonal contraception will undergo the multi-stressor training program. Receives: Other: Multi-Stressor Training |
| REPLACE (men): Multi-Stressor Training + Zoladex + AndroGel 5g | Experimental | Following GnRH agonist administration, men will be administered 5g/day (REPLACE) of topical 1% testosterone gel (AndroGel, Abbvie, North Chicago, IL) to be applied to the shoulders, upper arms, and/or stomach area daily. Receives: Drug: Goserelin 3.6 MG; Other: Multi-Stressor Training; Drug: Testosterone gel (AndroGel 5g) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomechanical: Tendon Cross-Sectional Area, change from baseline and throughout training, mean
Measured: Through study completion, an average of 8 weeks
Biomechanical: Tendon Shear Wave Elastography, change from baseline and throughout training, mean
Measured: Through study completion, an average of 8 weeks
Biomechanical: Tendon Thickness, change from baseline and throughout training, mean
Measured: Through study completion, an average of 8 weeks
Biomechanical: Quadriceps Muscle Cross-sectional Area, change from baseline and throughout training, mean
Measured: Through study completion, an average of 8 weeks
Biomechanical: Quadriceps Muscle Echointensity, change from baseline and throughout training, mean
Measured: Through study completion, an average of 8 weeks
Body composition: Lean mass, change from baseline, mean
Measured: Through study completion, an average of 8 weeks
Body Composition: Fat mass, change from baseline, mean
Measured: Through study completion, an average of 8 weeks
Body Composition: Body mass, change from baseline and throughout training, mean
Measured: Through study completion, an average of 8 weeks
Body Composition: Body Fat Percentage, change from baseline, mean
Measured: Through study completion, an average of 8 weeks
Biochemical: Bone turnover markers (CTx + P1NP), change from baseline, mean
Measured: Through study completion, an average of 8 weeks
Biochemical: Sex steroid hormones (Testosterone, Sex Hormone Binding Globulin, Estradiol), change from baseline and throughout training, mean
Measured: Through study completion, an average of 8 weeks
Secondary outcomes (4)
Bone microarchitecture: High Resolution- peripheral Computed Tomography, change from baseline, mean
Measured: Through study completion, an average of 8 weeks
Biochemical: Cell culture, extracellular vesicles, micro- RNAs, change from baseline and throughout study, mean
Measured: Through study completion, an average of 8 weeks
Biochemical: Measures of inflammation (IL6, IL-1B, TNFa, CRP), change from baseline and throughout study, mean
Measured: Through study completion, an average of 8 weeks
Biochemical: Measures of anabolism (Growth Hormone, Insulin-like growth factor-1), change from baseline and throughout study, mean
Measured: Through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start15 Jul 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bradley Nindl
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor-investigator, Bradley Nindl, University of Pittsburgh
- Investigators
- Bradley C Nindl, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455969
- Sponsor's protocol ID
- STUDY23090134
- Acronym
- ARMOR
- Status last verified
- Aug 2026
- First submitted
- 6 Jun 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported, after identification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Resiliency and Adaptation to Sex Steroid Suppression and Replacement During Multi-Stressor Training
- ClinicalTrials.gov ID
- NCT06455969
- Acronym / sponsor ID
- ARMOR / STUDY23090134
- Conditions
- Musculoskeletal Injury, Hypogonadism, Hormonal Contraception
- Keywords
- Military, Multi-stressor Training, Tendon, Muscle, Bone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bradley NindlUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-combat-related muscle, tendon and bone injuries are the most common injuries suffered by military personnel, particularly in new recruits. These injuries impact military readiness and are responsible for roughly 60% of limited duty days, 65% of soldiers who are unable to deploy, and nearly $500 million in medical cost to the government annually in the Army alone. Drug interventions must be studied and developed to prevent these negative outcomes and prepare military personnel for the demands of military service. At the current time, military leadership has identified critical gaps in understanding how to minimize these injuries and train soldiers with drug intervention serving among those gaps.
The goal of this study is to determine how a hormonal intervention can change muscle, tendon, and bone function as well as physical and psychological performance in response to mental and physical stress. To do so, we will examine sex hormone (testosterone, estrogen) levels, muscle, tendon, and bone images, blood samples, and physical and mental performance. We will look at things like changes in hormone levels, chemicals released from active skeletal muscles, and your body composition. The results from this study will be used to improve physical readiness training in the military with the goal of reducing injuries.
Detailed description
Suppression of the reproductive hypothalamic-pituitary-gonadal (HPG) axis is a common physiological response to strenuous military training and can be difficult to replicate in simulated environments. Additionally, whether HPG suppression (through pharmacological suppression or hormonal contraceptive use) contributes to the physiological changes, performance decrements, and high MSK injury risk associated with multi-stressor military training is unknown. Thus, we will 1) utilize pharmacological inhibition of the HPG axis to test if testosterone replacement in men will mitigate injury risk and performance decrements following military-relevant multi-stressor training and 2) investigate how hormonal contraceptive use in women may impact these outcomes. This project aims to deliver a state-of-the-art evaluation of male and female adaptive responses to multi-stressor training and evidence-based guidance for the safe and ethical use of exogenous hormone replacement as a MSK injury mitigation solution during multi-stressor training and operations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CONTROL (men + women) | No intervention | –The control group will maintain their habitual exercise, diet, and sleep patterns, all of which will be monitored throughout the study. |
| STRESS (men + women): Multi-Stressor Training | Active comparator | Other: Multi-Stressor TrainingResearch volunteers will be randomized into the stress exposure group (STRESS) will undergo a 4-week exercise training program consisting of 5 consecutive days of strenuous physical training followed by 2 days of recovery (energy balance, no structured exercise). The exercise training program will consist of military-relevant physical training exercises (e.g., load carriage, aerobic and resistance exercises) that progressively increase in duration and intensity to increase exercise energy expenditure. Participants will perform multiple exercises per day using a variety of endurance and muscle loading modalities designed to mimic movements typically observed during real-life military operations. |
| SUPPRESS (men): Multi-Stressor Training + Zoladex + AndroGel 1.25g | Experimental | Drug: Goserelin 3.6 MG, Other: Multi-Stressor Training, Drug: Testosterone gel (AndroGel 1.25g)In addition to participating in the multi-stressor training program, male participants randomized to the GnRH suppressed (SUPPRESS) group will be administered a long-acting GnRH agonist (Zoladex) by trained medical professionals to suppress endogenous gonadal steroids. Following GnRH agonist administration, men will be administered 1.25g/day (SUPPRESS) of topical 1% testosterone gel (AndroGel, Abbvie, North Chicago, IL) to be applied to the shoulders, upper arms, and/or stomach area daily. |
| Hormonal Contraceptive Use (women): Multi-stressor training + Hormonal Contraceptive Use | Active comparator | Other: Multi-Stressor TrainingFemale participants who report that they are currently using hormonal contraception will undergo the multi-stressor training program. |
| REPLACE (men): Multi-Stressor Training + Zoladex + AndroGel 5g | Experimental | Drug: Goserelin 3.6 MG, Other: Multi-Stressor Training, Drug: Testosterone gel (AndroGel 5g)Following GnRH agonist administration, men will be administered 5g/day (REPLACE) of topical 1% testosterone gel (AndroGel, Abbvie, North Chicago, IL) to be applied to the shoulders, upper arms, and/or stomach area daily. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Age 18-40 years
- body mass index (BMI) 18-30 kg/m2
- weight stable (±10 lbs) in past 2 months
- takes part in moderate physical activity for at least 150 minutes/week
- currently free of upper or lower body /extremity injury or impairment
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goserelin 3.6 MGAlso: ZoladexGoserelin acetate (Zoladex) is a gonadotropin-releasing hormone agonist (GnRH). GnRH agonists induce a transient increase in sex hormone concentrations, but subsequently inhibit gonadotropin secretion and the production of testosterone in men and estrogen in women. An equilibration period will occur to allow steroid concentrations to reduce. | Drug | REPLACE (men): Multi-Stressor Training + Zoladex + AndroGel 5g, SUPPRESS (men): Multi-Stressor Training + Zoladex + AndroGel 1.25g |
| Multi-Stressor TrainingA 4-week physical training program that mimics military training. | Other | Hormonal Contraceptive Use (women): Multi-stressor training + Hormonal Contraceptive Use, REPLACE (men): Multi-Stressor Training + Zoladex + AndroGel 5g, STRESS (men + women): Multi-Stressor Training, SUPPRESS (men): Multi-Stressor Training + Zoladex + AndroGel 1.25g |
| Testosterone gel (AndroGel 5g)Male subjects will be randomly assigned to receive a topical testosterone gel (5g dose). | Drug | REPLACE (men): Multi-Stressor Training + Zoladex + AndroGel 5g |
| Testosterone gel (AndroGel 1.25g)Male subjects will be randomly assigned to receive a topical testosterone gel (1.25g dose). | Drug | SUPPRESS (men): Multi-Stressor Training + Zoladex + AndroGel 1.25g |
Primary outcome
Biomechanical: Tendon Cross-Sectional Area, change from baseline and throughout training, mean
Time frame: Through study completion, an average of 8 weeks
Biomechanical: Tendon Shear Wave Elastography, change from baseline and throughout training, mean
Time frame: Through study completion, an average of 8 weeks
Biomechanical: Tendon Thickness, change from baseline and throughout training, mean
Time frame: Through study completion, an average of 8 weeks
Biomechanical: Quadriceps Muscle Cross-sectional Area, change from baseline and throughout training, mean
Time frame: Through study completion, an average of 8 weeks
Biomechanical: Quadriceps Muscle Echointensity, change from baseline and throughout training, mean
Time frame: Through study completion, an average of 8 weeks
Body composition: Lean mass, change from baseline, mean
Time frame: Through study completion, an average of 8 weeks
Body Composition: Fat mass, change from baseline, mean
Time frame: Through study completion, an average of 8 weeks
Body Composition: Body mass, change from baseline and throughout training, mean
Time frame: Through study completion, an average of 8 weeks
Body Composition: Body Fat Percentage, change from baseline, mean
Time frame: Through study completion, an average of 8 weeks
Biochemical: Bone turnover markers (CTx + P1NP), change from baseline, mean
Time frame: Through study completion, an average of 8 weeks
Biochemical: Sex steroid hormones (Testosterone, Sex Hormone Binding Globulin, Estradiol), change from baseline and throughout training, mean
Time frame: Through study completion, an average of 8 weeks
4 secondary outcomes
Bone microarchitecture: High Resolution- peripheral Computed Tomography, change from baseline, mean
Time frame: Through study completion, an average of 8 weeks
Biochemical: Cell culture, extracellular vesicles, micro- RNAs, change from baseline and throughout study, mean
Time frame: Through study completion, an average of 8 weeks
Biochemical: Measures of inflammation (IL6, IL-1B, TNFa, CRP), change from baseline and throughout study, mean
Time frame: Through study completion, an average of 8 weeks
Biochemical: Measures of anabolism (Growth Hormone, Insulin-like growth factor-1), change from baseline and throughout study, mean
Time frame: Through study completion, an average of 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Lab WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported, after identification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bradley C Nindl, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Goserelin 3.6 MG, Multi-Stressor Training and Testosterone gel (AndroGel 5g) in people with Musculoskeletal Injury and Hypogonadism, run by Bradley Nindl at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bradley C Nindl, PhD (412-246-0460, bnindl@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomechanical: Tendon Cross-Sectional Area, change from baseline and throughout training, mean (time frame: Through study completion, an average of 8 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.