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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT02419105
Eligibility Criteria:
Inclusion Criteria:
1. Men with documented total testosterone levels \< 11.30 nmol/l
2. Able to come to the study centre (Community-dwelling or institutionalized)
3. Age 65+ years
4. At a higher risk for falling
5. Body mass index \> 18.0 and \< 35.0 kg/m2
6. Understands German in reading and writing plus able to read, understand, and complete questionnaires and tests.
7. Willingness to limit additional vitamin D3 intake to a maximum of 800 IU per day
8. Willingness to limit calcium supplement intake to 500 mg/day
9. Willingness to stop active vitamin D metabolites
10. Willingness to forgo any additional use/application of testosterone products for the duration of the trial.
11. Participant understands the study procedures, alternative treatments available and risks involved with the study and voluntarily agrees to participate by giving a written informed consent.
12. Participant meets the routine clinical laboratory safety screening tests performed at screening visit.
13. Participant is able and willing to perform all study tests, attend all required office visits, and provide blood and urine samples.
14. Participant is able to apply the testosterone/placebo gel and is able to drink the vitamin D/placebo solution.
15. Participant is mentally competent (judicious) defined by having score \> 24 on the Folstein's mini mental state examination (MMSE) at the screening visit.
Exclusion Criteria:
1. Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product
2. Treatment with vitamin K-antagonists, insulin, adrenocorticotropic hormone (ACTH), corticosteroid (\>5mg/d)
3. Elevated (≥ 4.0 ng/ml) prostate-specific antigen levels (at screening) and/or palpable signs of prostate cancer
4. Palpable signs of breast-cancer
5. Haemoglobin ≤ 100 g/l
6. Haematocrit ≥ 0.50 L/L
7. Liver function values (alanine aminotransferase, aspartate aminotransferase, Gamma-glutamyl transferase, alkaline phosphatase) more than 3 times the upper limit of normal.
8. Consumption of \>800 IU vitamin D on any day in the 6 months prior to enrolment. Provision: a person can be enrolled as soon as the mean intake in the last 6 months and since the last dose is ≤ 800 IU.
9. Elevated serum calcium ≥ 2.60 mmol/l (adjusted for albumin )
10. Estimated (Cockcroft and Gault formula ) creatinine clearance ≤ 30 ml/min
11. Severe visual or hearing impairment
12. History of cancer \< 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer
13. Myocardial infarction in the last 3 months, unstable angina pectoris and/or exertional dyspnoea \>=NYHA III
14. Treatment worthy but untreated sleep apnoea or chronic (obstructive) pulmonary disease, epilepsy
15. Significant end-stage disease, i.e. genitourinary, cardiovascular, hepatic, renal, endocrine, hematologic, psychiatric, or pulmonary disease, which, in the opinion of the investigator, may pose a high risk to the patient or impair the patient's ability to complete the trial or confound the results
16. Uncontrolled hypertension (blood pressure mm Hg ≥ 180 systolic or ≥ 110 diastolic)
17. Alcohol abuse or alcoholic disease
18. Participation in another interventional research trial within the last 6 months prior to screening
19. Severe gait impairment, e.g. due to Parkinson's disease or hemiplegia
20. Previous enrolment into the current study
21. Enrolment of the investigator, his/her family members, employees and other dependent persons
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
65 Years
Study:
NCT02419105
Study Brief:
Protocol Section:
NCT02419105