Transfer of transdermally applied testosterone to clothing: A comparison of a testosterone patch versus a testosterone gel

被引:23
作者
Mazer, N
Fisher, D
Fischer, J
Cosgrove, M
Bell, D
Eilers, B
机构
[1] Watson Labs Inc, Med Affairs, Salt Lake City, UT USA
[2] Univ Utah, Salt Lake City, UT USA
[3] AAI Dev Serv, Shawnee, KS USA
[4] Diabet & Glandular Dis Res Assoc, San Antonio, TX USA
[5] Clin Res Serv, Clin R&D, Carlsbad, CA USA
关键词
male topical treatment; male sex steroid replacement; male design methodology of clinical trials;
D O I
10.1111/j.1743-6109.2005.20232.x
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
Aim. To assess the amount of testosterone transferred from the abdominal application sites of a transdermal testosterone patch and a transdermal testosterone gel to cotton T-shirts worn for 24 hours during each treatment. Methods. During a crossover study comparing the pharmacokinetics of a testosterone patch versus a testosterone gel in 28 hypogonadal men, subjects wore fresh cotton T-shirts for 24 hours on the seventh and fourteenth days of each treatment and during a 24-hour baseline period. At the end of each evaluation, the abdominal section of the shirt was carefully cut out, extracted in alcohol, and analyzed for testosterone by a direct radioimmunoassay. The minimum quantifiable amount of testosterone was 0.03 mu g per T-shirt sample. Results. The median amounts of extracted testosterone were 0.44 mu g for the baseline samples, 25.4 mu g for the average of the two patch samples, and 6,762.7 mu g for the average of the two gel samples (all comparisons P < 0.0001). Significant correlations were observed between the day 7 and day 14 data for both the patch (R = 0.4982. P < 0.01) and the gel (R = 0.8383; P < 0.0001). No significant correlations were found between the baseline, patch, or gel data, or between these and any demographic or pharmacokinetic parameters. A quantitative interpretation of the findings suggests that the baseline results are consistent with the transfer of testosterone in sweat; the patch results are probably due to the transfer of a small amount of residual testosterone left on the abdominal skin from the prior day's patches; and the gel results reflect die desquamation of stratum corneum containing a portion of the abdominally applied testosterone. Conclusions. There are large differences in the amount of testosterone that can be transferred from the application sites of transdermal patches and gels. The latter should be covered with clothing to minimize transfer through intimate skin-to-skin contact.
引用
收藏
页码:227 / 234
页数:8
相关论文
共 21 条
[1]  
*AUX PHARM INC, 2003, PRESCR INF
[2]  
DELANOE D, 1984, LANCET, V1, P276
[3]   ESTIMATION OF SEBUM PRODUCTION-RATES IN MAN BY MEASUREMENT OF THE SQUALENE CONTENT OF SKIN BIOPSIES [J].
DOWNING, DT ;
STEWART, ME ;
STRAUSS, JS .
JOURNAL OF INVESTIGATIVE DERMATOLOGY, 1981, 77 (04) :358-360
[4]   The organization of human epidermis: Functional epidermal units and phi proportionality [J].
Hoath, SB ;
Leahy, DG .
JOURNAL OF INVESTIGATIVE DERMATOLOGY, 2003, 121 (06) :1440-1446
[5]   INTRANUCLEAR ANDROGEN AND CYTOSOLIC RECEPTOR CONCENTRATIONS IN THE AXILLARY SKIN OF OSMIDROSIS [J].
KURATA, S ;
ITAMI, S ;
KOMADA, S ;
TAKAYASU, S .
ARCHIVES OF DERMATOLOGICAL RESEARCH, 1990, 282 (01) :33-37
[6]   Comparison of the steady-state pharmacokinetics, metabolism, and variability of a transdermal testosterone patch versus a transdermal testosterone gel in hypogonadal men [J].
Mazer, N ;
Bell, D ;
Wu, JY ;
Fischer, J ;
Cosgrove, M ;
Eilers, B .
JOURNAL OF SEXUAL MEDICINE, 2005, 2 (02) :213-226
[7]  
Mazer NA, 2002, INT J FERTIL WOMEN M, V47, P77
[8]  
MOORE N, 1988, LANCET, V1, P468
[9]  
*NAT WEATH SERV FO, MONTHL ANN AV TEMP
[10]   Variations in regional sweat composition in normal human males [J].
Patterson, MJ ;
Galloway, SDR ;
Nimmo, MA .
EXPERIMENTAL PHYSIOLOGY, 2000, 85 (06) :869-875