Pharmacokinetics of a new testosterone transdermal delivery system, TDS®-testosterone in healthy males

British Journal of Clinical Pharmacology

Volumn 61, Issue 3, 2006, Pages 275-279

  Chik, Z ^b   Johnston, A ^a,b   Tucker, A T ^b,d   Chew, S L ^a   Michaels, L ^d   Alam, C A S ^c  

^a QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^b Clinical Pharmacology   (United Kingdom)

^c Experimental Pathology   (United Kingdom)

^d ST BARTHOLOMEW S HOSPITAL   (United Kingdom)

Author keywords

Bioequivalence; Pharmacokinetics; TDS ; Testosterone; Transdermal delivery

Indexed keywords

PLACEBO; TESTOSTERONE;

ABSENCE OF SIDE EFFECTS; ADULT; AEROSOL; ANALYSIS OF VARIANCE; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; COMPARATIVE STUDY; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG FORMULATION; GEL; HORMONE BLOOD LEVEL; HUMAN; MALE; NORMAL HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STATISTICAL SIGNIFICANCE;

ADMINISTRATION, CUTANEOUS; ADMINISTRATION, TOPICAL; ADULT; AREA UNDER CURVE; DRUG DELIVERY SYSTEMS; HUMANS; MALE; TESTOSTERONE; THERAPEUTIC EQUIVALENCY;

EID: 33644912036     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2005.02542.x     Document Type: Article

References (18)

1. Bremner WJ Vitiello MV Prinz PN. Loss of circadian rhythmicity in blood testosterone levels with aging in normal men J Clin Endocrinol Metab 1983 56 1278 81
2. Handelsman DJ Conway AJ Boylan LM. Pharmacokinetics and pharmacodynamics of testosterone pellets in man J Clin Endocrinol Metab 1990 71 216 22
3. Korenman SG Viosca S Garza D Guralnik M Place V Campbell P Davis SS Androgen therapy of hypogonadal men with transscrotal testosterone systems Am J Med 1987 83 471 8
4. Dobs AS Meikle AW Arver S Sanders SW Caramelli KE Mazer NA. Pharmacokinetics, efficacy, and safety of a permeation-enhanced testosterone transdermal system in comparison with bi-weekly injections of testosterone enanthate for the treatment of hypogonadal men J Clin Endocrinol Metab 1999 84 3469 78
5. Johnsen SG Bennett EP Jensen VG. Therapeutic effectiveness of oral testosterone Lancet 1974 2 1473 5
6. Stuenkel CA Dudley RE Yen SS. Sublingual administration of testosterone-hydroxypropyl-beta-cyclodextrin inclusion complex simulates episodic androgen release in hypogonadal men J Clin Endocrinol Metab 1991 72 1054 9
7. Jockenhovel F. Testosterone supplementation: what and how to give Aging Male 2003 6 200 6
8. Swerdloff RS Wang C Cunningham G Dobs A Iranmanesh A Matsumoto AM Snyder PJ Weber T Longstreth J Berman N Long-term pharmacokinetics of transdermal testosterone gel in hypogonadal men J Clin Endocrinol Metab 2000 85 4500 10
9. Gooren LJ Bunck MC. Transdermal testosterone delivery. testosterone patch and gel World J Urol 2003 21 316 9
10. Matsumoto AM. Hormonal therapy of male hypogonadism Endocrinol Metab Clin North Am 1994 23 857 75
11. Snyder PJ. In Goodman and Gilman's The Pharmacological Basis of Therapeutics Tenth edition, eds Hardman JG Limbird LE. New York McGraw Hill 2001; 1635 1645
12. Behre HM. Comparative pharmacokinetics of testosterone esters. In TestosteroneAction, Deficiency, Substitution 2nd edn. eds Nieschlag E Behre HM. Springer-Verlag Berlin 1998; 329 48
13. Bird DR Vowles KD. Liver damage from long-term methyltestosterone Lancet 1977 2 400 1
14. Westaby D Ogle SJ Paradinas FJ Randell JB Murray-Lyon IM. Liver damage from long-term methyltestosterone Lancet 1977 2 262 3
15. Lowdell CP Murray-Lyon IM. Reversal of liver damage due to long term methyltestosterone and safety of non-17 alpha-alkylated androgens BMJ 1985 291 637
16. Behre HM von Eckardstein S Kliesch S Nieschlag E. Long-term substitution therapy of hypogonadal men with transscrotal testosterone over 7-10 years Clin Endocrinol (Oxf) 1999 50 629 35
17. ® Summary of Product Characteristics, 2002 accessed 4/4/2005
18. Pabst G Jaeger H. Review of methods and criteria for the evaluation of bioequivalence studies Eur J Clin Pharmacol 1990 38 5 10