NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)

NCT01092858 | Terminated Phase 4

• 2 other identifiers: 148532009-017139-16
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypogonadism

Keywords

Testosterone undecanoate; Hypogonadism

Outcome Measures

Primary Outcomes (1)

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

  At baseline, at week 54

Secondary Outcomes (8)

• Isometric maximum strength

  At baseline, at week 54

• Grip strength

  At baseline, at week 54

• Chair raising test

  At baseline, at week 54

• Arm curl test

  At baseline, at week 54

• Bicycle stress test with spirometry

  At baseline, at week 54

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Testosterone Undeconate (Nebido, BAY86-5037)

Arm 2

PLACEBO COMPARATOR

Drug: Placebo

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

Arm 1

Placebo DRUG

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

Arm 2

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Cologne, North Rhine-Westphalia, 50931, Germany

Location

Related Links

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MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone Propionate; testosterone undecanoate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Testosterone; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: March 25, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 5, 2014

Record last verified: 2014-11

Locations

DE (1)