NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)

Hypogonadism Clinical Trial

Official title:

Effect of Exercise Alone or in Combination With Testosterone Replacement on Muscle Strength and Quality of Life in Older Men With Low Testosterone Concentrations: a Randomized Double-blind, Placebo Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01092858
• Other study ID #: 14853
• Secondary ID: 2009-017139-16
• Status: Terminated
• Phase: Phase 4
• First received: March 24, 2010
• Last updated: November 3, 2014
• Start date: September 2010
• Est. completion date: July 2011

Study information

• Verified date: November 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Testosterone Undeconate (Nebido, BAY86-5037)
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
• Placebo
Matching placebo i.m. injections at baseline, at week 6, at week 18 at week 30 and at week 42, respectively

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic maximum strength -one repetition maximum (1-RM ) - of upper and lower extremity after 54 weeks		At baseline, at week 54	No
Secondary	Isometric maximum strength		At baseline, at week 54	No
Secondary	Grip strength		At baseline, at week 54	No
Secondary	Chair raising test		At baseline, at week 54	No
Secondary	Arm curl test		At baseline, at week 54	No
Secondary	Bicycle stress test with spirometry		At baseline, at week 54	No
Secondary	SF-36 Questionnaire		At baseline, at week 54	No
Secondary	AMS-Questionnaire		At baseline, at week 54	No
Secondary	FINGER Questionnaire		At baseline, at week 54	No

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