A new combination of testosterone and nestorone transdermal gels for male hormonal contraception

Journal of Clinical Endocrinology and Metabolism

Volumn 97, Issue 10, 2012, Pages 3476-3486

  Ilani, Niloufar ^a   Roth, Mara Y ^b   Amory, John K ^b   Swerdloff, Ronald S ^a   Dart, Clint ^c   Page, Stephanie T ^b   Bremner, William J ^b   Sitruk Ware, Regine ^d   Kumar, Narender ^d   Blithe, Diana L ^e   Wang, Christina ^a  

^a HARBOR UCLA MEDICAL CENTER   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c Health Decisions   (United States)

^d POPULATION COUNCIL   (United States)

^e EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ELCOMETRINE; FOLLITROPIN; LUTEINIZING HORMONE; PLACEBO; TESTOSTERONE;

ACNE; ADULT; AGGRESSION; ANORGASMIA; ARTICLE; CONTROLLED STUDY; DEPRESSION; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG WITHDRAWAL; DRY SKIN; ENERGY; FATIGUE; HORMONAL CONTRACEPTION; HUMAN; HUMAN EXPERIMENT; INHIBITION KINETICS; INSOMNIA; IRRITABILITY; LIBIDO DISORDER; LIMIT OF QUANTITATION; MALE; MOOD CHANGE; MULTICENTER STUDY; NORMAL HUMAN; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEXUAL FUNCTION; SIDE EFFECT; SKIN EXFOLIATION; SPERMATOGENESIS; SPERMATOZOON COUNT; SPERMATOZOON MOTILITY; VOLUNTEER; WEIGHT GAIN;

ADMINISTRATION, CUTANEOUS; ADOLESCENT; ADULT; ANDROGENS; CONTRACEPTION; CONTRACEPTIVE AGENTS, FEMALE; DRUG COMBINATIONS; GELS; HUMANS; MALE; MIDDLE AGED; NORPROGESTERONES; PATIENT SATISFACTION; SEXUALITY; SPERMATOGENESIS; TESTOSTERONE; YOUNG ADULT;

EID: 84867271392     PISSN: 0021972X     EISSN: 19457197     Source Type: Journal    
DOI: 10.1210/jc.2012-1384     Document Type: Article

References (41)

1. Vaughan B, Trussell J, Kost K, Singh S, Jones R 2008 Discontinuation and resumption of contraceptive use: results from the 2002 National Survey of Family Growth. Contraception 78:271-283
2. Martin CW, Anderson RA, Cheng L, Ho PC, van der Spuy Z, Smith KB, Glasier AF, Everington D, Baird DT 2000 Potential impact of hormonal male contraception: cross-cultural implications for development of novel preparations. Hum Reprod 15:637-645 (Pubitemid 30142376)
3. Heinemann K, Saad F, Wiesemes M, White S, Heinemann L 2005 Attitudes toward male fertility control: results of a multinational survey on four continents. Hum Reprod 20:549-556 (Pubitemid 40277631)
4. Glasier AF, Anakwe R, Everington D, Martin CW, van der Spuy Z, Cheng L, Ho PC, Anderson RA 2000 Would women trust their partners to use a male pill? Hum Reprod 15:646-649
5. Gu Y, Liang X, Wu W, Liu M, Song S, Cheng L, Bo L, Xiong C, Wang X, Liu X, Peng L, Yao K 2009 Multicenter contraceptive efficacy trial of injectable testosterone undecanoate in Chinese men. J Clin Endocrinol Metab 94:1910-1915
6. Gu YQ, Wang XH, Xu D, Peng L, Cheng LF, Huang MK, Huang ZJ, Zhang GY 2003 A multicenter contraceptive efficacy study of injectable testosterone undecanoate in healthy Chinese men. J Clin Endocrinol Metab 88:562-568 (Pubitemid 36207791)
7. Turner L, Conway AJ, Jimenez M, Liu PY, Forbes E, McLachlan RI, Handelsman DJ 2003 Contraceptive efficacy of a depot progestin and androgen combination in men. J Clin Endocrinol Metab 88:4659-4667 (Pubitemid 37357508)
8. World Health Organization Task Force on Methods for the Regulation of Male Fertility 1990 Contraceptive efficacy of testosterone-induced azoospermia in normal men. World Health Organization Task Force on methods for the regulation of male fertility. Lancet 336:955-959
9. World Health Organization Task Force on Methods for the Regulation of Male Fertility 1996 Contraceptive efficacy of testosterone-induced azoospermia and oligozoospermia in normal men. Fertil Steril 65:821-829
10. Ilani N, Liu PY, Swerdloff RS, Wang C 2011 Does ethnicity matter in male hormonal contraceptive efficacy? Asian J Androl 13:579-584
11. Liu PY, Swerdloff RS, Anawalt BD, Anderson RA, Bremner WJ, Elliesen J, Gu YQ, Kersemaekers WM, McLachlan RI, Meriggiola MC, Nieschlag E, Sitruk-Ware R, Vogelsong K, Wang XH, Wu FC, Zitzmann M, Handelsman DJ, Wang C 2008 Determinants of the rate and extent of spermatogenic suppression during hormonal male contraception: an integrated analysis. J Clin Endocrinol Metab 93:1774-1783 (Pubitemid 351656517)
12. Gu YQ, Tong JS, Ma DZ, Wang XH, Yuan D, Tang WH, Bremner WJ 2004 Male hormonal contraception: effects of injections of testosterone undecanoate and depot medroxyprogesterone acetate at eight-week intervals in Chinese men. J Clin Endocrinol Metab 89:2254-2262 (Pubitemid 38619861)
13. Handelsman DJ, Conway AJ, Howe CJ, Turner L, Mackey MA 1996 Establishing the minimum effective dose and additive effects of depot progestin in suppression of human spermatogenesis by a testosterone depot. J Clin Endocrinol Metab 81:4113-4121 (Pubitemid 26380426)
14. Kamischke A, Ploger D, Venherm S, von Eckardstein S, von Eckardstein A, Nieschlag E 2000 Intramuscular testosterone undecanoate with or without oral levonorgestrel: a randomized placebo-controlled feasibility study for male contraception. Clin Endocrinol (Oxf) 53:43-52 (Pubitemid 30646125)
15. Kamischke A, Venherm S, Plöger D, von Eckardstein S, Nieschlag E 2001 Intramuscular testosterone undecanoate and norethisterone enanthate in a clinical trial for male contraception. J Clin Endocrinol Metab 86:303-309 (Pubitemid 32109810)
16. Meriggiola MC, Costantino A, Saad F, D'Emidio L, Morselli Labate AM, Bertaccini A, Bremner WJ, Rudolph I, Ernst M, Kirsch B, Martorana G, Pelusi G 2005 Norethisterone enanthate plus testosterone undecanoate for male contraception: effects of various injection intervals on spermatogenesis, reproductive hormones, testis, and prostate. J Clin Endocrinol Metab 90:2005-2014 (Pubitemid 40586232)
17. Meriggiola MC, Farley TM, Mbizvo MT 2003 A review of androgen-progestin regimens for male contraception. J Androl 24:466-483 (Pubitemid 38129045)
18. Nieschlag E, Zitzmann M, Kamischke A 2003 Use of progestins in male contraception. Steroids 68:965-972 (Pubitemid 37532421)
19. Page ST, Amory JK, Anawalt BD, Irwig MS, Brockenbrough AT, Matsumoto AM, Bremner WJ 2006 Testosterone gel combined with depomedroxyprogesterone acetate is an effective male hormonal contraceptive regimen and is not enhanced by the addition of a GnRH antagonist. J Clin Endocrinol Metab 91:4374-4380 (Pubitemid 44833412)
20. Wu FC, Aitken RJ 1989 Suppression of sperm function by depot medroxyprogesterone acetate and testosterone enanthate in steroid male contraception. Fertil Steril 51:691-698 (Pubitemid 19097788)
21. Bebb RA, Anawalt BD, Christensen RB, Paulsen CA, Bremner WJ, Matsumoto AM 1996 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 81:757-762 (Pubitemid 26055696)
22. Mommers E, Kersemaekers WM, Elliesen J, Kepers M, Apter D, Behre HM, Beynon J, Bouloux PM, Costantino A, Gerbershagen HP, Grønlund L, Heger-Mahn D, Huhtaniemi I, Koldewijn EL, Lange C, Lindenberg S, Meriggiola MC, Meuleman E, Mulders PF, Nieschlag E, Perheentupa A, Solomon A, Väisälä L, Wu FC, Zitzmann M 2008 Male hormonal contraception: a double-blind, placebo-controlled study. J Clin Endocrinol Metab 93:2572-2580 (Pubitemid 352008522)
23. Wang C, Wang XH, Nelson AL, Lee KK, Cui YG, Tong JS, Berman N, Lumbreras L, Leung A, Hull L, Desai S, Swerdloff RS 2006 Levonorgestrel implants enhanced the suppression of spermatogenesis by testosterone implants: comparison between Chinese and non-Chinese men. J Clin Endocrinol Metab 91:460-470 (Pubitemid 43236910)
24. Wang C, Swerdloff RS 2004 Male hormonal contraception. Am J Obstet Gynecol 190:S60-S68 (Pubitemid 38561495)
25. Sitruk-Ware R, Nath A 2010 The use of newer progestins for contraception. Contraception 82:410-417
26. Mahabadi V, Amory JK, Swerdloff RS, Bremner WJ, Page ST, Sitruk-Ware R, Christensen PD, Kumar N, Tsong YY, Blithe D, Wang C 2009 Combined transdermal testosterone gel and the progestin nestorone suppresses serum gonadotropins in men. J Clin Endocrinol Metab 94:2313-2320
27. Lee KK, Berman N, Alexander GM, Hull L, Swerdloff RS, Wang C 2003 A simple self-report diary for assessing psychosexual function in hypogonadal men. J Androl 24:688-698 (Pubitemid 38133070)
28. World Health Organization 2010 World Health Organization Laboratory Manual for the Examination and Processing of Human Semen. 5th ed. Geneva: World Health Organization
29. Lähteenmäki P, Weiner E, Lähteenmäki P, Johansson E, Luukkainen T 1981 Contraception with subcutaneous capsules containing ST-1435. Pituitary and ovarian function and plasma levels of ST-1435. Contraception 23:63-75 (Pubitemid 11191306)
30. Shiraishi S, Lee PW, Leung A, Goh VH, Swerdloff RS, Wang C 2008 Simultaneous measurement of serum testosterone and dihydrotestosterone by liquid chromatography-tandem mass spectrometry. Clin Chem 54:1855-1863
31. Qoubaitary A, Meriggiola C, Ng CM, Lumbreras L, Cerpolini S, Pelusi G, Christensen PD, Hull L, Swerdloff RS, Wang C 2006 Pharmacokinetics of testosterone undecanoate injected alone or in combination with norethisterone enanthate in healthy men. J Androl 27:853-867 (Pubitemid 44846026)
32. Swerdloff RS, Wang C, Cunningham G, Dobs A, Iranmanesh A, Matsumoto AM, Snyder PJ, Weber T, Longstreth J, Berman N 2000 Long-term pharmacokinetics of transdermal testosterone gel in hypogonadal men. J Clin Endocrinol Metab 85:4500-4510 (Pubitemid 32157624)
33. Nieschlag E 2007 10th Summit Meeting consensus: recommendations for regulatory approval for hormonal male contraception. October 22-23, 2006. Contraception 75:166-167 (Pubitemid 46217193)
34. Büchter D, von Eckardstein S, von Eckardstein A, Kamischke A, Simoni M, Behre HM, Nieschlag E 1999 Clinical trial of transdermal testosterone and oral levonorgestrel for male contraception. J Clin Endocrinol Metab 84:1244-1249 (Pubitemid 30644384)
35. Hair WM, Kitteridge K, O'Connor DB, Wu FC 2001 A novel male contraceptive pill-patch combination: oral desogestrel and transdermal testosterone in the suppression of spermatogenesis in normal men. J Clin Endocrinol Metab 86:5201-5209 (Pubitemid 33070236)
36. Gonzalo IT, Swerdloff RS, Nelson AL, Clevenger B, Garcia R, Berman N, Wang C 2002 Levonorgestrel Implants (Norplant II) for male contraception clinical trials: combination with transdermal and injectable testosterone. J Clin Endocrinol Metab 87:3562-3572 (Pubitemid 34879497)
37. Handelsman DJ 2002 Optimal power transformations for analysis of sperm concentration and other semen variables. J Androl 23:629-634 (Pubitemid 34977518)
38. Anawalt BD, Bebb RA, Bremner WJ, Matsumoto AM 1999 A lower dosage levonorgestrel and testosterone combination effectively suppresses spermatogenesis and circulating gonadotropin levels with fewer metabolic effects than higher dosage combinations. J Androl 20:407-414 (Pubitemid 29289101)
39. Laurikka-Routti M 1992 Serum lipids, blood pressure, body weight, and serum chemistry in women using subcutaneous contraceptive implants releasing the progestin ST 1435. Obstet Gynecol 80:855-859
40. Lopez LM, Grimes DA, Schulz KF 2007 Steroidal contraceptives: effect on carbohydrate metabolism in women without diabetes mellitus. Cochrane Database Syst Rev CD006133
41. Wang C, Cunningham G, Dobs A, Iranmanesh A, Matsumoto AM, Snyder PJ, Weber T, Berman N, Hull L, Swerdloff RS 2004 Long-term testosterone gel (AndroGel) treatment maintains beneficial effects on sexual function and mood, lean and fat mass, and bone mineral density in hypogonadal men. J Clin Endocrinol Metab 89:2085-2098 (Pubitemid 38619836)