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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT01092858
Eligibility Criteria:
Inclusion Criteria:
* Men aged 60 years and older (\>60yrs), untrained
* Symptomatic hypogonadism as defined by a) and b)
* a) Total testosterone below 12 nmol/l (measurement 7.00-11.00 a.m.)
* b)Total Aging Males' symptom score above 36
* Willing to avoid significant change in the pattern of physical exercise and lifestyle for the duration of the study
* Residence in Cologne Area
Exclusion Criteria:
* Previous assignment to treatment during this study
* Use of androgen therapy or anabolic steroids respectively 12 months of entry into the study (i.e. screening visit/visit 1)
* Current participation in an exercise program or within the last 6 months
* Suspicion or known history of prostate or breast cancer or other hormone dependent neoplasia
* Abnormal finding on Digital Rectal Examination (DRE)
* Prostate specific antigen (PSA) level \>4 ng/ml
* History of clinically significant post void residual urine (\> 150 ml)
* Suspicion or known history of liver tumor
* Hypersensitivity to the active substances or any of the excipients of NEBIDO e.g. benzyl-benzoate and castor oil
* Blood coagulation irregularities presenting an increased risk of bleeding after intramuscular injections including vitamin-K-antagonists or other strong anticoagulants
* 32 Additional Exclusion Criteria
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
60 Years
Study:
NCT01092858
Study Brief:
Protocol Section:
NCT01092858