Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT05964920
Eligibility Criteria:
Inclusion Criteria:
* Sedentary males
* 55-70 years old
* Serum testosterone levels \>8 nmol/L measured in the morning
* Without any known illness, disease or other conditions
* Undergone screening through medical questionnaire, physical examination, routine blood tests and urine sample
* Written informed consent received
Exclusion Criteria:
* Current or previous participation in a formal exercise regime
* A BMI \< 18 or \> 30 kg·m2
* Hypersensitivity to the study drug or to any of its constituents
* Active cardiovascular disease: uncontrolled hypertension (BP \> 160/100 mmHg), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event
* Family history of early (\<55y) death from cardiovascular disease
* Haematocrit \>50%
* Malignancy
* Prostate-specific antigen (PSA) \>4 ng/mL
* Lower urinary tract symptoms
* Taking beta-adrenergic blocking agents, statins, non-steroidal anti-inflammatory drugs
* Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial), epilepsy
* Respiratory diseases including: pulmonary hypertension, chronic obstructive pulmanary disease (COPD), asthma, sleep apnoea
* Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, type 1 or 2 diabetes
* Active inflammatory bowel or renal disease
* Current or previous steroid treatment or hormone replacement therapy
* Clotting dysfunction
* Musculoskeletal or neurological disorders
* Alcohol or drug abuse
* Receiving oral anticoagulants
* Serum testosterone levels above the reference range for 50 year olds (\>32 nmol/L) (Bjerner et al., 2009) measured in the morning 1
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
55 Years
Maximum Age:
70 Years
Study:
NCT05964920
Study Brief:
Protocol Section:
NCT05964920