Efficacy and safety of a new testosterone-in-adhesive matrix patch applied every 2 days for 1 year to hypogonadal men

Journal of Steroid Biochemistry and Molecular Biology

Volumn 109, Issue 1-2, 2008, Pages 168-176

  Raynaud, Jean Pierre ^a   Legros, Jean Jacques ^b   Rollet, Jacques ^c   Augès, Marie ^d   Bunouf, Pierre ^d   Sournac, Michel ^d   Fiet, Jean ^e  

^a SORBONNE UNIVERSITÉ   (France)

^b UNIVERSITY OF LIÈGE   (Belgium)

^c Institut Rhône Alpin   (France)

^d INSTITUT DE RECHERCHE PIERRE FABRE   (France)

^e HENRI MONDOR HOSPITAL   (France)

Author keywords

Hormone therapy; Hypogonadism; Testosterone; Transdermal delivery system

Indexed keywords

ANDROSTANOLONE; ESTROGEN; FOLLITROPIN; LUTEINIZING HORMONE; PROSTATE SPECIFIC ANTIGEN; SEX HORMONE BINDING GLOBULIN; TESTOPATCH; TESTOSTERONE; TESTOSTERONE ENANTATE; UNCLASSIFIED DRUG;

ADULT; AGED; APPLICATION SITE ERYTHEMA; APPLICATION SITE PAPULE; APPLICATION SITE REACTION; ARTICLE; BLOOD SAMPLING; BODY MASS; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG SAFETY; ERYTHROCYTE; ERYTHROCYTE COUNT; ESTROGEN BLOOD LEVEL; GASTROINTESTINAL DISEASE; HEADACHE; HUMAN; HYPOGONADISM; INFECTION; LIPID ANALYSIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MUSCLE DISEASE; PROSTATE SPECIFIC ANTIGEN BLOOD LEVEL; PROSTATITIS; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SCORING SYSTEM; SEXUAL FUNCTION; SIDE EFFECT; SYMPTOM; TESTOSTERONE BLOOD LEVEL; TRANSDERMAL PATCH; TREATMENT DURATION; TRIACYLGLYCEROL BLOOD LEVEL;

ADHESIVENESS; ADHESIVES; ADMINISTRATION, CUTANEOUS; ADOLESCENT; ADULT; AGED; ANDROSTENEDIONE; BIOLOGICAL AVAILABILITY; DELAYED-ACTION PREPARATIONS; DIHYDROTESTOSTERONE; DRUG ADMINISTRATION SCHEDULE; DRUG DELIVERY SYSTEMS; DRUG TOLERANCE; HUMANS; HYPOGONADISM; INJECTIONS, INTRAMUSCULAR; MALE; MIDDLE AGED; PROSTATE-SPECIFIC ANTIGEN; SAFETY; TESTOSTERONE; TIME FACTORS;

EID: 40849133645     PISSN: 09600760     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jsbmb.2007.10.010     Document Type: Article

References (29)

1. Bhasin S. Clinical review 34: androgen treatment of hypogonadal men. J. Clin. Endocrinol. Metab. 74 6 (1992) 1221-1225
2. Meikle A.W., Arver S., Dobs A.S., Sanders S.W., Rajaram L., and Mazer N.A. Pharmacokinetics and metabolism of a permeation-enhanced testosterone transdermal system in hypogonadal men: influence of application site-a clinical research center study. J. Clin. Endocrinol. Metab. 81 5 (1996) 1832-1840
3. Snyder P.J., and Lawrence D.A. Treatment of male hypogonadism with testosterone enanthate. J. Clin. Endocrinol. Metab. 51 6 (1980) 1335-1339
4. Wilson J.D., and Griffin J.E. The use and misuse of androgens. Metabolism 29 12 (1980) 1278-1295
5. Burris A.S., Banks S.M., Sue Carter C., Davidson J.M., and Sherins R.J. A long-term, prospective study of the physiologic and behavioral effects of hormone replacement in untreated hypogonadal men. J. Androl. 13 4 (1992) 297-304
6. Nieschlag E., and Behre H.M. Testoterone therapy. In: Nieschlag E. (Ed). Andrologie vol. 15 (1996), Springer-Verlag, Berlin 297-308
7. Cunningham G.R., Cordero E., and Thornby J.I. Testosterone replacement with transdermal therapeutic systems. Physiological serum testosterone and elevated dihydrotestosterone levels. JAMA 261 (1989) 2525-2530
8. Meikle A.W., Mazer N.A., Moellmer J.F., Stringham J.D., Tolman K.G., Sanders S.W., and Odell W.D. Enhanced transdermal delivery of testosterone across nonscrotal skin produces physiological concentrations of testosterone and its metabolites in hypogonadal men. J. Clin. Endocrinol. Metab. 74 3 (1992) 623-628
9. Wang C., et al. Transdermal testosterone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogonadal men. J. Clin. Endocrinol. Metab. 85 8 (2000) 2839-2853
10. Fiet J., Giton F., Boudi A., Boudou P., Soliman H., Villette J.M., and Galons H. Development of a sensitive and specific new plasma 4-androstene-3,17-dione time-resolved fluoroimmuno-assay (TR-FIA). Steroids 66 8 (2001) 609-614
11. Fiet J., Giton F., Fidaa I., Valleix A., Galons H., and Raynaud J.-P. Development of a highly sensitive and specific new testosterone time-resolved fluoroimmuno-assay in human serum. Steroids 69 8 (2004) 461-471
12. Heinemann L.A.J., Zimmermann T., Vermeulen A., Thiel C., and Hummel W. A new "aging males symptoms" rating scales. Aging Male 2 (1999) 105-114
13. Marquis P., and Marrel A. Reproducibility and clinical and concurrent validity of the MSF-4: a four-item male sexual function questionnaire for patients with benign prostatic hyperplasia. Value Health 4 4 (2001) 335-343
14. Food and Drug Administration, Centre for drug evaluation and research, Guidance for industry, Skin irritation and sensitization testing of generic transdermal drug products, 1999.
15. Salehian B., Wang C., Alexander G., Davidson T., McDonald V., Berman N., Dudley R.E., Ziel F., and Swerdloff R.S. Pharmacokinetics, bioefficacy, and safety of sublingual testosterone cyclodextrin in hypogonadal men: comparison to testosterone enanthate-a clinical research center study. J. Clin. Endocrinol. Metab. 80 12 (1995) 3567-3575
16. Dobs A.S., Meikle S.A.W., Arver S., Sanders S.W., Caramelli K.E., and Mazer N.A. 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. 84 10 (1999) 3469-3478
17. Mazer N.A., Heiber W.E., Moellmer J.-F., Meikle A.W., Stringham J.D., Sanders S.W., Tolman K.G., and Odell W.D. Enhanced transdermal delivery of testosterone: a new physiological approach for androgen replacement in hypogonadal men. J. Control. Release 19 (1992) 347-362
18. Giton F., Urien S., Born C., Tichet J., Guéchot J., Callebert J., Bronsard F., Raynaud J.-P., and Fiet J. Determination of bioavailable testosterone (non-sex hormone-binding globulin [SHBG]-bound testosterone) in a population of healthy French men: influence of androsenediol on tesosterone binding to SHBG. Clin. Chem. 53 12 (2007) 2160-2168
19. Skakkebaek N.E., Bancroft J., Davidson D.W., and Warner P. Androgen replacement with oral testosterone undecanoate in hypogonodal men: a double blind controlled study. Clin. Endocrinol. 14 (1981) 49-61
20. Behre H.M., von Eckardstein S., Kliesch S., and Nieschlag E. Long-term substitution therapy of hypogonadal men with transscrotal testosterone over 7-10 years. Clin. Endocrinol. 50 (1999) 629-635
21. Ahmed S.R., Boucher A.E., Manni A., Santen R.J., Bartholomew M., and Demers L.M. Transdermal testosterone therapy in the treatment of male hypogonadism. J. Clin. Endocrinol. Metab. 66 (1988) 546-551
22. Jockenhövel F. Practical aspects of testosterone substitution. Aging Male 5 1 (2002) 21-32
23. Behre H.M., Bohmeyer J., and Nieschlag E. Prostate volume in testosterone-treated and untreated hypogonadal men in comparison to age-matched normal controls. Clin. Endocrinol. 40 (1994) 341-349
24. Ozata M., Bulur M., Beyhan Z., Sengül A., Saglam M., Turan M., Corakci A., and Ali Gundogan M. Effects of gonadotropin and testosterone treatments on prostate volume and serum prostate specific antigen levels in male hypogonadism. Endocr. J. 44 5 (1997) 719-724
25. Tenover J.S. Effects of testosterone supplementation in the aging male. J. Clin. Endocrinol. Metab. 75 4 (1992) 1092-1098
26. Bhasin S., Cunningham G.R., Hayes F.J., Matsumoto A.M., Snyder P.J., Swerdloff R.S., and Montori V.M. Testosterone therapy in adult men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J. Clin. Endocrinol. Metab. 91 (2006) 1995-2010
27. Arver S., Dobs A.S., Meikle A.W., Allen R.P., Sanders S.W., and Mazer N.A. Improvement of sexual function in testosterone deficient men treated for 1 year with a permeation enhanced testosterone transdermal system. J. Urol. 155 (1996) 1604-1608
28. T'Sjoen G., Goemaere S., De Meyere M., and Kaufman J.M. Perception of males' aging symptoms, health and well-being in elderly community dwelling men is not related to circulating androgen levels. Psychoneuroendocrinology (2003) 1-12
29. Snyder P.J., Peachey H., Berlin J.A., Hannoush P., Haddad G., Dlewati A., Santanna J., Loh L., Lenrow D.A., Holmes J.H., Kapoor S.C., Atkinson L.E., and Strom B.L. Effects of testosterone replacement in hypogonadal men. J. Clin. Endocrinol. Metab. 85 8 (2000) 2670-2677