NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)

Phase 4TerminatedNCT01092858

Bayer4 enrolled

Overview

The design of the study is a standard double-blind design, which is needed in this study to allow for unbiased evaluation of efficacy and safety. The effect of the additional impact of testosterone replacement therapy in hypogonadal men on muscle strength and quality of life in comparison to physical exercise alone will be assessed. Treatment duration will be 54 weeks, to monitor the increase as well as the "steady state" of the parameters assessed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypogonadism

Interventions

Testosterone Undeconate (Nebido, BAY86-5037)DRUG

Testosterone undecanoate 1000 mg (4 ml) i.m. injection at baseline, at week 6, at week 18, at week 30 and at week 42, respectively

PlaceboDRUG

Matching placebo i.m. injections at baseline, at week 6, at week 18 at week 30 and at week 42, respectively

Eligibility

Sex: MALEMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Cologne, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Dynamic maximum strength -one repetition maximum (1-RM ) - of upper and lower extremity after 54 weeks