A Phase 4 interventional study of Goserelin 3.6 MG and Multi-Stressor Training in Musculoskeletal Injury, Hypogonadism and Hormonal Contraception, sponsored by Bradley Nindl. Recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Bradley Nindl · Phase 4, Interventional, and Basic science
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.
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.
320 studies on the registry are indexed under Hypogonadism; 39 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 243 interventional studies indexed under Hypogonadism.
Browse Hypogonadism studies →This is the only study on the registry with Bradley Nindl as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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 , 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 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 (ALT) and aspartate aminotransferase (AST) > 2x the 39) Serum > 2 mg/dL 40) Serum alkaline phosphatase > 150 U/L 41) Plasma \< 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The control group will maintain their habitual exercise, diet, and sleep patterns, all of which will be monitored throughout the study.
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.
Other: Multi-Stressor Training
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.
Drug: Goserelin 3.6 MG · Other: Multi-Stressor Training · Drug: Testosterone gel (AndroGel 1.25g)
Female participants who report that they are currently using hormonal contraception will undergo the multi-stressor training program.
Other: Multi-Stressor Training
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.
Drug: Goserelin 3.6 MG · Other: Multi-Stressor Training · Drug: Testosterone gel (AndroGel 5g)
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.
Also known as: Zoladex
A 4-week physical training program that mimics military training.
Male subjects will be randomly assigned to receive a topical testosterone gel (5g dose).
Male subjects will be randomly assigned to receive a topical testosterone gel (1.25g dose).
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
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
Plan to share: Yes — Individual participant data that underlie the results reported, after identification (text, tables, figures, and appendices).
Supporting information: Statistical analysis plan
Time frame: Beginning 1 year and ending 5 years following publication.
Access criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For individual participant data meta-analysis. Proposals should be directed to bnindl@pitt.edu. To gain access, data requesters will need to sign a data access agreement.
Started Jul 2024 (actual). Primary completion is estimated for Aug 2027, 37 months after the start.
Of 21 phase 4 interventional studies under Hypogonadism, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 72. This study's planned 37 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Goserelin · Testosterone