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New treatment option for Musculoskeletal Injury
Official title Adaptions and Resiliency to Multi-Stressor OpeRations
ClinicalTrials.gov ID: NCT06455969
What this study is testing
What is Goserelin 3.6 MG?
Goserelin 3.6 MG is an investigational medicine, being studied as a potential treatment for musculoskeletal injury.
Also referred to as Zoladex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- Current smoker
- current clinical diagnosis of an eating disorder
- use of medication incompatible with measurement of reproductive and metabolic hormones or which may interfere with any of the study outcomes
- current oligo/amenorrhea in women
- any metabolic or endocrine disease
- has been diagnosed with a medical condition, physical or psychological, that currently prevents potential people from exercising
See the full eligibility criteria
- 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
- 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 men, total testosterone concentration within normal physiological range (300-1000 ng/dL)
- in women, eumenorrheic (cycles of 26-35 days) and not using hormonal contraceptives for previous 3 months
- Current smoker
- current clinical diagnosis of an eating disorder
- use of medication incompatible with measurement of reproductive and metabolic hormones or which may interfere with any of the study outcomes
- current oligo/amenorrhea in women
- any metabolic or endocrine disease
- has been diagnosed with a medical condition, physical or psychological, that currently prevents potential people from exercising
- currently pregnant or becomes pregnant during the study
- history of heart condition OR high blood pressure
- treating physician requires subject participates in medically supervised physical activity only
- history of drug addiction, or regular use of recreational drugs
- currently undergoing treatment for or have a history of mental health conditions
- irregular lab results (e.g., PSA \>3 ng/mL)
- Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, Cushing's, diabetes mellitus or renal insufficiency
- 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...
- History of deep vein thrombosis, pulmonary embolism, or clotting disorders.
- History of stroke or myocardial infarction
- Serum 25-hydroxyvitamin D \< 20 ng/mL
- Thyroid dysfunction
- Serum creatinine \> 2 mg/dL
- Personal history or history of a first-degree relative with breast cancer
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2x the upper limit of normal
- Serum bilirubin \> 2 mg/dL
- Serum alkaline phosphatase \> 150 U/L
- Plasma hemoglobin \< 10 gm/dL
- Hematocrit \> 50
- Fracture within the last 6 months.
- Serum testosterone level \ 1070 ng/dL
- Systolic blood pressure \> 160 or diastolic blood pressure \> 95
- Active substance abuse
- Triglycerides \> 150 fasting
- History of hereditary angioedema
- History of chest pain at rest, during daily activities of living, or when performing physical activity
- Musculoskeletal injury removing subject from physical activity for more than a month within the past 2 years
- Recreational drug use more than 2 times per month in each of the previous 6 months
- Self-reported vision is worse than 20/20.
- Personal history or history of a first-degree relative with breast cancer
- Experienced a fracture within the last 6 months
- participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
- Diagnosed with eating disorder
- Have food allergies, intolerance, restriction, or special diet needs
- History of endometriosis
- Current diagnosis of reproductive health issues, such as ovarian cysts, PCOS, pelvic lesions, undiagnosed ovarian enlargement
- Have undiagnosed abnormal vaginal bleeding
- Currently breastfeeding or within 2 months after stopping breastfeeding
- Have dietary restrictions
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.