A Phase 4 interventional study of NEBIDO and PLACEBO in Hypogonadism, sponsored by Bayer. Withdrawn at 25 sites in 6 countries. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2012-11-27.
Sponsored by Bayer · Phase 4, Interventional, and Treatment
To evaluate the safety and efficacy of Nebido compared to placebo in elderly men aged 50 and over with symptomatic late onset hypogonadism
Explorative objectives: Change in grip strength (Subgroup only: optional for sites with experienced in testing muscle function); Change in physical performance test i.e. lower limb muscle strength (subgroup only; optional for sites experienced in testing muscle function). Please note that the 2 explorative objectives mentioned above must be performed together. All measured at baseline, week 30, week 54, no safety measure. Safety parameters Prostate safety: digital rectal examination (DRE) Measured at screening, week 30+ 54, safety measure. International prostate symptom score (IPSS): International prostate symptom score (IPSS) Measured at screening, week 18, 30, 42, 54, safety measure. Laboratory tests for lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides) and liver function tests (aspartate aminotransferase (AST) and alanine transaminase (ALT)) Measured at screening, week 6, 18, 30, 42, 54, safety measure. Standard laboratory tests for androgen treatment: prostate specific antigen (PSA); hemoglobin; hematocritMeasured at screening, week 6, 18, 30, 42, 54, safety measureAdverse eventsMeasured at screening, baseline, week 6, 18, 30, 42, 54Vital signsMeasured at screening, week 18, 30, 42, 54, safety measure.
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Exclusion Criteria:
Drug: NEBIDO
Drug: PLACEBO
Patients will receive 54 weeks of treatment with Nebido, 5 intramuscular injections of 4ml Nebido (at baseline, week 6, 18, 30, 42)
Patients will receive 54 weeks of treatment with placebo, 5 intramuscular injections of 4ml placebo (at baseline, week 6, 18, 30, 42)
To assess the change from baseline in lean body mass after 54 weeks of treatment with NEBIDO compared to placebo
Time frame: Baseline, week 30, week 54
Change from baseline in total body mass
Time frame: Baseline, week 30, week 54
Change from baseline in fat mass
Time frame: Baseline, week 30, week 54
Change from baseline in bone mineral density
Time frame: Baseline, week 30, week 54
Aging Male Symptoms (AMS) rating scale
Time frame: Baseline, week 30, week 54
International Index of Erectile Function- erectile function domain (IIEF-EF)
Time frame: Baseline, week 30, week 54
Change in serum levels of testosterone (central laboratory)
Time frame: Baseline, week 30, week 54
Change in waist circumference
Time frame: Baseline, week 30, week 54
This study is withdrawn, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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