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Bioidentical Andromen Testosterone Cream Final Study Report

Bioidentical Andromen Testosterone Cream Final Study Report

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Published by lance1949
Description of the uses that AndroMen Testosterone Cream has on a men's health, well being and lifestyle.

Information for men on the efficacy and effective use of Lawley Pharmaceuticals bioidentical testosterone cream.
Description of the uses that AndroMen Testosterone Cream has on a men's health, well being and lifestyle.

Information for men on the efficacy and effective use of Lawley Pharmaceuticals bioidentical testosterone cream.

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Categories:Types, Brochures
Published by: lance1949 on Aug 11, 2009
Copyright:Attribution Non-commercial

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10/01/2012

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Long-Term Pharmacokinetics and Clinical Efficacyof Andromen
®
Forte 5% Cream for AndrogenReplacement Therapy in Hypogonadal Men
Final Study Report 
Principal Investigator: 
Professor DJ Handelsman
 
 , 
Centre Investigators: 
 
Department of Andrology, Concord Hospital Sydney NSW 2139 
 
S Kelleher, LP Ly, M Jimenez, DJ Handelsman
 
Prince Henry’s Institute of Medical Research,Monash Medical Centre, Clayton VIC 3168 
 A Clare, R I Mc Lachlan
Department of Medicine (Endocrinology) St George Hospital Belgrave Street, Kogarah NSW 2217 
 A O’Sullivan
Study Sponsor: 
 
Lawley Pharmaceuticals672 Beaufort Street, Mt Lawley, WA, 6050
 
Study Administration: 
 
 ANZAC Research Institute, Sydney NSW 2139Phone (02) 9767 0100, FAX (020) 9767 9101Email: djh@anzac.edu.au 
Study Date: 
March 2002 – August 2003
 
Report Date: 
June 2004
 
 Andromen Forte 5% Cream Efficacy Study Final Report 
TABLE OF CONTENTS
PageTable of Contents 1List of Tables 2List of Figures 2Summary 3
1.
Study design
 
41.1 Title 41.2 Objectives 41.3 Product 41.4 Regulatory status 41.5 Protocol features 5Design 5Participants 5Run-off from previous androgen replacement therapy 5Dose titration 5Titration procedure 5Pharmacokinetic sampling 5Study end-points 6Sample size 61.6 Ethical approval 6Risk-benefit evaluation 61.7 Subject selection criteria 7Inclusion criteria 7Exclusion criteria 7Discontinuation criteria 71.8 Procedures 8Participants 8Study centres 8Blood and urine sampling 8Physical assessment 8 Application site monitoring 9Questionnaires 91.9 Assays 91.10 Data analysis 9
2. Results
 
102.1 Participants 102.2 Doses: Randomisation and Titration 102.3 Adverse effects 112.4 Continuation of cream usage after study 112.5 Subject compliance 112.6 Pharmacokinetics 11Baseline and trough blood testosterone concentrations 11Blood testosterone AUC and other pharmacokinetic variables 122.7 Blood LH, FSH and SHBG 122.8 Hematology and biochemistry 122.9 Anthropometric measures 122.10 Prostate 122.11 Quality of life questionnaires 12
3. Discussion
13
4. Conclusion
15
 Appendix
 – Validation of testosterone assay
 
31
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35
 
 
 Andromen Forte 5% Cream Efficacy Study Final Report 
Tables Page
Table 1 Characteristics of subjects at baseline 16Table 2 Testosterone pharmacokinetic parameters according to dose and time 17Table 3a Anthropometry and hormones according to initial dose 18Table 3b Hematology and biochemistry to initial dose 19Table 3c Quality of life according to initial dose 20Table 4a - Anthropometry and hormones according to final dose 21Table 4b Hematology and biochemistry according to final dose 22Table 4c Quality of life according to final dose 23Table 5 - Quality of Life (SF-36) of androgen deficient men before and at endof study compared with the age-matched healthy Australian norms24Table 6 Leading symptoms of androgen deficiency 25
Figures
Figure 1 – Blood testosterone concentrations during detailed 24 hourpharmacokinetic sampling at weeks 0, 4 and 12 for all participants26Figure 2 – Blood testosterone concentrations during detailed 24 hourpharmacokinetic sampling at weeks 0 and 4 according to initial dose (50 mg or100 mg per day)27Figure 3 – Blood testosterone concentrations during detailed 24 hourpharmacokinetic sampling at weeks 12 according to final dose (<100 mg, 100mg or 150 mg mg per day)28Figure 4 – Blood LH and FSH at baseline, at 4 weeks and individual changesaccording to initial dose (50 mg or 100 mg per day)29Figure 4 – Blood LH and FSH at baseline, at 12 weeks and individual changesaccording to final dose (<100 mg, 100 mg or 150 mg mg per day)30
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What an excellent site! M.P. M.D.
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