New clinical applications of transdermal testosterone delivery in men and women

Journal of Controlled Release

Volumn 65, Issue 1-2, 2000, Pages 303-315

  Mazer, Norman A ^a  

^a TheraTech Inc   (United States)

Author keywords

Clinical; HIV; Pharmacokinetics; Testosterone; Transdermal

Indexed keywords

TESTOSTERONE;

ADOLESCENT; ADULT; ARTICLE; BETA THALASSEMIA; CIRCADIAN RHYTHM; CLINICAL ARTICLE; DOSE RESPONSE; DRUG DELIVERY SYSTEM; DRUG METABOLISM; FEMALE; HORMONE SUBSTITUTION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPOGONADISM; MALE; OVARIECTOMY; OVARY INSUFFICIENCY; PREMENSTRUAL SYNDROME; PRIORITY JOURNAL; TESTOSTERONE BLOOD LEVEL; TESTOSTERONE RELEASE;

ADMINISTRATION, CUTANEOUS; ADULT; BETA-THALASSEMIA; CONTRACEPTIVE AGENTS, MALE; DRUG DELIVERY SYSTEMS; FEMALE; HIV INFECTIONS; HORMONE REPLACEMENT THERAPY; HUMANS; HYPOGONADISM; MALE; TESTOSTERONE;

EID: 0034005437     PISSN: 01683659     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0168-3659(99)00252-7     Document Type: Article

References (46)

1. Mazer N.A., Heiber W.E., Moellmer J.F., Meikle A.W., Stringham J.D., Sanders S.W., Tolman K.G., Odell W.D. Enhanced transdermal delivery of testosteone: a new physiological approach for androgen replacement in hypogonadal men. J. Contr. Rel. 19:1992;347-362.
2. Nieschlag E., Behre H.M. Pharmacology and clinical uses of testosterone. Nieschlag E., Behre H.M. Testosterone: Action, Deficiency, Substitution. 2nd ed :1998;293-328 Springer-Verlag, Berlin.
3. Behre H.M., Nieschlag E. Comparative pharmacokinetics of testosterone esters. Nieschlag E., Behre H.M. Testosterone: Action, Deficiency, Substitution. 2nd Edition :1998;329-348 Springer-Verlag, Berlin.
4. Watts N.B., Notelovitz M., Timmons M.C., Addison W.A., Wiita B., Downey L.J. Comparison of oral estrogens and estrogens plus androgen on bone mineral density, menopausal symptoms, and lipid-lipoprotein profiles in surgical menopause. Obstet. Gynecol. 85:1995;529-537.
5. Schaison G., Couzinet B. Percutaneous dihydrotestosterone treatment. Nieschlag E., Behre H.M. Testosterone: Action, Deficiency, Substitution. 2nd Edition :1998;329-348 Springer-Verlag, Berlin.
6. Arver S., Dobs A.S., Meikle A.W., Caramelli K.E., Rajaram L., Sanders S.W., Mazer N.A. Long-term efficacy and safety of a permeation-enhanced testosterone transdermal system in hypogonadal men. Clin. Endocrinol. 47:1997;727-737.
7. Meikle A.W., Arver S., Dobs A.S., Sanders S.W., Rajaram L., Mazer N.A. Pharmacokinetics and metabolism of a permeation-enhanced testosterone transdermal system in hypogonadal men: influence of application site - a clinical research study. J. Clin. Endocrinol. Metab. 81:1996;1832-1840.
8. ® testosterone transdermal system in hypogonadal adolescents and young men with β-thalassemia major. J. Pediat. Endocrinol. Metab. 11:1998;891-900.
9. Bowen A.J., Caramelli K.E., Mazer N.A. Physiological testosterone replacement for women: pharmacokinetics of experimental transdermal matrix patches in surgically menopausal subjects. 80th Annual Meeting of the Endocrine Society, New Orleans, LA :June 24-27, 1998;. Abstract P3-59.
10. Miller K., Corcoran C., Armstrong C., Caramelli K., Anderson E., Cotton D., Basgoz N., Hirschhorn L., Tuomala R., Schoenfield D., Daugherty C., Mazer N., Grinspoon S. Transdermal testosterone administration in women with acquired immunodeficiency syndrome: a pilot study. J. Clin. Endocrinol. Metab. 83:1998;2717-2725.
11. Bhasin S., Bremner W.J. Clinical Review 85: Emerging issues in androgen replacement therapy. J. Clin. Endocrinol. Metab. 82:1997;3-8.
12. Bhasin S., Storer T.W., Asbel-Sethi N., Kilbourne A., Hays R., Sinha-Hikim I., Shen R., Arver S., Beall G. Effects of testosterone replacement with a non-genital, transdermal system, Androderm, in human immunodeficiency virus-infected men with low testosterone levels. J. Clin. Endocrinol. Metab. 83:1998;3155-3162.
13. Rommerts F.F.G. Testosterone: an overview of biosynthesis, transport, metabolism and nongenomic actions. Nieschlag E., Behre H.M. Testosterone: Action, Deficiency, Substitution. 2nd Edition :1998;1-32 Springer-Verlag, Berlin.
14. Mazer N.A., Sanders S.W., Ebert C.D., Meikle A.W. Mimicking the circadian pattern of testosterone and metabolite levels with an enhanced transdermal delivery system. Gurney R., Junginger H., Peppas N. Pulsatile Drug Delivery: Current Applications and Future Trends. 1993;73-97 Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart.
15. Mazer N.A. Enhanced transdermal delivery of testosterone using the Theraderm™ TDS. Crommelin D.J.A., Midha K.K. Topics in Pharmaceutical Sciences 1991. 1992;149-170 Medpharm Scientific Publishers, Stuttgart.
16. ® CIII, Physicians Desk Reference. 53rd Edition :1999;3025-3028 Medical Economics Co, Montvale, NJ.
17. Boyar R.M., Rosenfeld R.S., Kapen S., Finkelstein J.W., Roffwarg H.P., Weitzman E.D., Hellman L. Human puberty: simultaneous augmented secretion of luteinizing hormone and testosterone during sleep. J. Clin. Invest. 54:1974;609-618.
18. De Sanctis V., Vullo C., Ughi M., Bagni B., Cavallini A., Caramelli K., Rajaram L., Sanders S., Mazer N. Pharmacokinetics of a permeation-enhanced testosterone transdermal system (TTD) in adolescent hypogonadal males with β-thalassemia major. International Congress of Endocrinology, San Francisco, CA :June 12-13, 1996;. Abstract P2-396.
19. Southren A.L., Gordon G.G., Tochimoto S. Further study of factors affecting the metabolic clearance rate of testosterone in man. J. Endocrinol. Metab. 28:1968;1105-1112.
20. Longcope C. Adrenal and gonadal androgen secretion in normal females. Clin. Endocrinol. Metab. 15:1986;213-228.
21. Abraham G.E. Ovarian and adrenal contribution to peripheral androgens during the menstrual cycle. J. Clin. Endocrinol. Metab. 69:1974;533-539.
22. Rosenfield R.L., Helke J.C. Small diurnal and episodic fluctuations of the plasma free testosterone level in women. Am. J. Obstet. Gynecol. 120:1974;461-465.
23. Steinberger E., Ayala C., His B., Smith K.D., Rodriguez-Rigau L.J., Weidman E.R., Reimondo G.G. Utilization of commercial laboratory results in management of hyperandrogenism in women. Endocr. Pract. 4:1998;1-10.
24. Plymate S.R., Paulsen C.A. Male Hypogonadism. Becker K. Principles and Practice of Endocrinology. 1990;948-970 Lippincott, Philadelphia.
25. Chlebowski R.T., Heber D. Hypogonadism in male patients with metastatic cancer prior to chemotherapy. Cancer Res. 42:1982;2495-2498.
26. Kamischke A., Kemper D.E., Castel M.A., Luthke M., Rolf C., Behre H.M., Magnussen H., Nieschlag E. Testosterone levels in men with chronic obstructive pulmonary disease with or without glucocorticoid therapy. Eur. Respir. J. 11:1998;41-45.
27. Bjorntorp P. Endocrine abnormalities in obesity. Diabetes Reviews. 5:1997;52-68.
28. Cutolo M., Balleari E., Giusti M., Intra E S. Accardo, Androgen replacement therapy in male patients with rheumatoid arthritis. Arth. Rheum. 34:1991;1-5.
29. Bhasin S., Tenover J.S. Age-associated sarcopenia - issues in the use of testosterone as an anabolic agent in older men. J. Clin. Endocrinol. Metab. 82:1997;1659-1660. Editorial.
30. Sih R., Morley J.E., Kaiser F.E., Perry H.M., Patrick P., Ross C. Testosterone replacement in older hypogonadal men: a 12 month randomized controlled trial. J. Clin. Endocrinol. Metab. 82:1997;1661-1667.
31. Sherwin B.B., Gelfand M.M., Brender W. Androgen enhances sexual motivation in females: a prospective, crossover study of sex steroid administration in the surgical menopause. Psychosom. Med. 47:1985;339-351.
32. Davis S.R., Burger H.G. Androgens and the postmenopausal woman. J. Clin. Endocrinol. Metab. 81:1996;2759-2763.
33. Kaplan H.S., Owett T. The female androgen deficiency syndrome. J. Sex Marital Ther. 19:1993;3-24.
34. Lahita R.G., Bradlow H.L., Ginzler E., Pang S., New M. Low plasma androgens in women with systemic lupus erythematosus. Arth. Rheum. 30:1987;241-248.
35. Lahita R.G., Cheng C.Y., Monder C., Bardin C.W. Experience with 19-nortestosterone in the therapy of systemic lupus erythematosus: worsened disease after treatment with 19-nortestosterone in men and lack of improvement in women. J. Rheumatol. 19:1992;547-555.
36. Anasti J.N., Kalantaridou S.N., Kimzey L.M., Defensor R.A., Nelson L.M. Bone loss in young women with karyotypically normal spontaneous premature ovarian failure. Obstet. Gynecol. 91:1998;12-15.
37. Buckler H.M., Misra R., Cantrill J.A., Sheffield B., Anderson D.C. The use of low (100 mg) testosterone implants in severe premenstrual syndrome. J. Endocrinol. (suppl). 1989;123. abstract 34.
38. Grinspoon S., Corcoran C., Lee K., Burrows B., Hubbard J., Katznelson L., Walsh M., Guccione A., Cannan J., Heller H., Basgoz N., Klibanski A. Loss of lean body and muscle mass correlates with androgen levels in hypogonadal men with acquired immunodeficiency syndrome and wasting. J. Clin. Endocrinol. Metab. 81:1996;4051-4058.
39. Rabkin J.G., Rabkin R., Wagner G. Testosterone replacement therapy in HIV illness. Gen. Hosp. Psych. 17:1995;37-42.
40. Grinspoon S., Corcoran C., Miller K., Biller B.M.K., Askari H., Wang E., Hubbard J., Anderson E.J., Basgoz N., Heller H.M., Klibanski A. Body composition and endocrine function in women with acquired immunodeficiency syndrome wasting. J. Clin. Endocrinol. Metab. 82:1997;1332-1337.
41. Matsumoto A. Comments - Effects of chronic testosterone administration in normal men: safety and efficacy of high dosage testosterone and parallel dose-dependent suppression of luteinizing hormone, follicle-stimulating hormone, and sperm production. J. Clin. Endocrinol. Metab. 70:1990;282-287.
42. Swerdloff R.S., Tom L.K.S., Salameh W., Steiner B., Peterson M., Rivier J., Vale W., Bhasin S. Male contraception: achievement of reversible azoospermia by combined gonadotropin releasing hormone antagonist and testosterone enanthate. Contraception. 46:1992;193-195.
43. Bebb R.A., Anawalt B.D., Christensen R.B., Paulsen C.A., Bremner W.J., Matsumoto A.M. Combined administration of levonorgestrel and testosterone induces more rapid and effective suppression of spermatogenesis than testosterone alone: a promising male contraceptive approach. J. Clin. Endocrinol. Metab. 81:1996;757-762.
44. Meriggiola M.C., Bremner W.J., Paulsen C.A., Valdisserri A., Incorvaia L., Motta R., Pavani A., Capelli M., Flamigni C. A combined regimen of cyproterone acetate and testosterone enanthate as a potentially highly effective male contraceptive. J. Clin. Endocrinol. Metab. 81:1996;3018-3023.
45. Buechter D., von Eckardstein S., von Eckardstein A., Kamischke A., Simoni M., Behre H.M., Nieschlag E. Clinical trial of transdermal testosterone and oral levonorgestrel for male contraception. J. Clin. Endocrinol. Metab. 84:1999;1244-1249.
46. Hair W.M., Kitteridge K., Wu F.C.W. A new male contraceptive pill/patch combination - oral desogestrel and transdermal testosterone: suppression of gonadotrophins and spermatogenesis in men. 81st Annual Meeting of the Endocrine Society, San Diego, CA :June 12-15, 1999;. Abstract P3-374.