NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)

This study has been terminated.
Information provided by (Responsible Party):
Bayer Identifier:
First received: March 24, 2010
Last updated: November 3, 2014
Last verified: November 2014
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.

Condition Intervention Phase
Drug: Testosterone Undeconate (Nebido, BAY86-5037)
Drug: Placebo
Phase 4

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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Dynamic maximum strength -one repetition maximum (1-RM ) - of upper and lower extremity after 54 weeks [ Time Frame: At baseline, at week 54 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Isometric maximum strength [ Time Frame: At baseline, at week 54 ] [ Designated as safety issue: No ]
  • Grip strength [ Time Frame: At baseline, at week 54 ] [ Designated as safety issue: No ]
  • Chair raising test [ Time Frame: At baseline, at week 54 ] [ Designated as safety issue: No ]
  • Arm curl test [ Time Frame: At baseline, at week 54 ] [ Designated as safety issue: No ]
  • Bicycle stress test with spirometry [ Time Frame: At baseline, at week 54 ] [ Designated as safety issue: No ]
  • SF-36 Questionnaire [ Time Frame: At baseline, at week 54 ] [ Designated as safety issue: No ]
  • AMS-Questionnaire [ Time Frame: At baseline, at week 54 ] [ Designated as safety issue: No ]
  • FINGER Questionnaire [ Time Frame: At baseline, at week 54 ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: September 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 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 Comparator: Arm 2 Drug: Placebo
Matching placebo i.m. injections at baseline, at week 6, at week 18 at week 30 and at week 42, respectively


Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01092858

Köln, Nordrhein-Westfalen, Germany, 50931
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT01092858     History of Changes
Other Study ID Numbers: 14853  2009-017139-16 
Study First Received: March 24, 2010
Last Updated: November 3, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Testosterone undecanoate

Additional relevant MeSH terms:
Endocrine System Diseases
Gonadal Disorders
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on April 27, 2016