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NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)

This study has been terminated.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01092858
First received: March 24, 2010
Last updated: August 13, 2012
Last verified: August 2012
History of Changes
  Purpose

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
Hypogonadism
 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:

U.S. FDA Resources

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092858

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT01092858     History of Changes
Other Study ID Numbers: 14853, 2009-017139-16
Study First Received: March 24, 2010
Last Updated: August 13, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Testosterone undecanoate
Hypogonadism

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 22, 2013