7α-Methyl-19-nortestosterone (MENTR): The Population Council's contribution to research on male contraception and treatment of hypogonadism

Contraception

Volumn 87, Issue 3, 2013, Pages 288-295

  Nieschlag, Eberhard ^a   Kumar, Narender ^b   Sitruk Ware, Régine ^b  

^a UNIVERSITY HOSPITAL MÜNSTER   (Germany)

^b POPULATION COUNCIL   (United States)

Author keywords

Clinical trials; Hypogonadism; Male contraception; MENT

Indexed keywords

ETONOGESTREL; GONADOTROPIN; LEVONORGESTREL; MEDROXYPROGESTERONE ACETATE; NORETHISTERONE ENANTATE; PLACEBO; TESTOSTERONE; TESTOSTERONE 4 BUTYLCYCLOHEXANECARBOXYLATE; TESTOSTERONE ENANTATE; TESTOSTERONE UNDECANOATE; TRESTOLONE;

AZOOSPERMIA; CLINICAL EFFECTIVENESS; CONCEPTION; CONDOM; CONFERENCE PAPER; DRUG DEVELOPMENT; DRUG DOSE REDUCTION; DRUG FORMULATION; DRUG STRUCTURE; DRUG SYNTHESIS; DRUG WITHDRAWAL; GONADOTROPIN BLOOD LEVEL; HORMONAL CONTRACEPTION; HUMAN; HYPOGONADISM; LIBIDO; LONG TERM CARE; OLIGOSPERMIA; PHASE 3 CLINICAL TRIAL (TOPIC); PREGNANCY; PRESCRIPTION; SEMEN ANALYSIS; SEXUAL BEHAVIOR; SEXUAL FUNCTION; SIDE EFFECT; SPERMATOGENESIS; SPERMATOZOON COUNT; SPERMATOZOON DENSITY; TREATMENT DURATION;

CLINICAL TRIALS AS TOPIC; CONTRACEPTION; CONTRACEPTIVE AGENTS, MALE; HUMANS; HYPOGONADISM; MALE; NANDROLONE; TESTOSTERONE;

EID: 84873411588     PISSN: 00107824     EISSN: 18790518     Source Type: Journal    
DOI: 10.1016/j.contraception.2012.08.036     Document Type: Conference Paper

References (47)

1. K. Heinemann, F. Saad, M. Wiesemes, S. White, and L. Heinemann Attitudes toward male fertility control: results of a multinational survey on four continents Hum Reprod 20 2005 549 556
2. E. Nieschlag, and H.M. Behre Approaches to hormonal male contraception. E. Nieschlag, H.M. Behre, S. Nieschlag, Andrology: male reproductive health and dysfunction 3rd ed. 2010 Springer Heidelberg 577 587
3. L. O'Donnell, and R.E. MacLachlan The role of testosterone in spermatogenesis E. Nieschlag, H.M. Behre, Testosterone: action, deficiency, substitution 4th ed. 2012 Cambridge University Press Cambridge, UK 123 153
4. B.R. Srinath, E.J. Wickings, C. Witting, and E. Nieschlag Active immunization with follicle-stimulating hormone for fertility control: a 4 1/2-year study in male rhesus monkeys Fertil Steril 40 1983 110 117
5. E. Nieschlag, and H.M. Behre The essential role of testosterone in hormonal male contraception E. Nieschlag, H.M. Behre, Testosterone: action, deficiency, substitution 4th ed. 2012 Cambridge University Press Cambridge, UK 470 539
6. E. Nieschlag Clinical trials in male hormonal contraception Contraception 82 2010 457 470
7. A. Barfield, J. Melo, and E. Coutinho Pregnancies associated with sperm concentrations below 10 million/ml in clinical studies of a potential male contraceptive method, monthly depot medroxyprogesterone acetate and testosterone esters Contraception 20 1979 121 127
8. WHO laboratory manual for the examination and processing of human sperm. 5th ed., WHO Geneva 2010.
9. C. Mallidis, T.G. Cooper, B. Hellenkemper, M. Lablans, F. Ückert, and E. Nieschlag Ten years experience with an external quality control programme for semen analysis Fertil Steril 98 2012 611 616
10. World Health Organization Task Force on Methods for the Regulation of Male Fertility Contraceptive efficacy of testosterone-induced azoospermia in normal men Lancet 336 1990 955 959
11. World Health Organization Task Force on Methods for the Regulation of Male Fertility Contraceptive efficacy of testosterone-induced azoospermia and oligozoospermia in normal men Fertil Steril 65 1996 821 829
12. H.M. Behre, S. Baus, and S. Kliesch Potential of testosterone buciclate for male contraception: endocrine differences between responders and nonresponders J Clin Endocrinol Metab 80 1995 2394 2403
13. E. Nieschlag Testosterone treatment comes of age: new options for hypogonadal men Clin Endocrinol 65 2006 275 281
14. Y.-Q. Gu, X.-H. Wang, and D. Xu A multicenter contraceptive efficacy study of injectable testosterone undecanoate in healthy Chinese men J Clin Endocrinol Metab 88 2003 562 568
15. Y. Gu, X. Liang, and W. Wu Multicenter contraceptive efficacy trial of injectable testosterone undecanoate in Chinese men J Clin Endocrinol Metab 94 2009 1910 1915
16. L. Zhang, I.H. Shal, Y. Liu, K.M. Vogelsong, and L. Zhang The acceptabilityof an injectable, once-a-month male contraceptive in China Contraception 73 2006 548 553
17. A. Kamischke, S. Venherm, D. Plöger, S. von Eckardstein, and E. Nieschlag Intramuscular testosterone undecanoate and norethisterone enanthate in a clinical trial for male contraception J Clin Endocrinol Metab 86 2001 303 309
18. A. Kamischke, T. Heuermann, and K. Krüger An effective hormonal male contraceptive using testosterone undecanoate with oral or injectable norethisterone preparations J Clin Endocrinol Metab 87 2002 530 539
19. M.C. Meriggiola, A. Costantino, and F. Saad 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 2005 2014
20. WHO Controlled trials register NET-EN plus TU as a male contraceptive (WHO-HRP ID A25165) 2005 http://www.who.int/reproductive-health/rhl/a25165.html
21. http://conrad.org/contraception-trials.html (last accessed 30.6.2012).
22. E. Mommers, W.M. Kersemaeker, and J. Elliesen Male hormonal contraception: a double-blind, placebo-controlled study J Clin Endocrinol Metab 93 2008 2572 2580
23. E. Nieschlag, E. Vorona, M. Wenk, A.K. Hemker, A. Kamischke, and M. Zitzmann Hormonal male contraception in men with normal and subnormal semen parameters Int J Androl 34 2011 556 567
24. P.Y. Liu, R.S. Swerdloff, P.D. Christenson, D.J. Handelsman, and C. Wang Hormonal Male Contraception Summit Group. Rate, extent and modifiers of spermatogenic recovery after hormonal male contraception: an integrated analysis Lancet 367 2006 1412 1420
25. L. Turner, A.J. Conway, and M. Jiminez Contraceptive efficacy of a depot gestagen and androgen combination in men J Clin Endocrinol Metab 88 2003 4659 4667
26. J.C. Soufir, G. Meduri, and A. Ziyyat Spermatogenetic inhibition in men taking a combination of oral medroxyprogesterone acetate and percutaneous testosterone as a male contraceptive method Hum Reprod 26 2011 1708 1714
27. G.F. Weinbauer, S. Schlatt, V. Walter, and E. Nieschlag Testosterone-induced inhibition of spermatogenesis is more closely related to suppression of FSH than to testicular androgen levels in the cynomolgous monkey model J Endocrinol 168 2001 25 38
28. I. Sivin Risks and benefits, advantages and disadvantages of levonorgestrel-releasing contraceptive implants Drug Saf 26 2003 303 335
29. S.C. Lyster, and G.W. Duncan Anabolic, androgenic and myotropic activities of derivatives of 7alpha-methyl-19-nortestosterone Acta Endocrinol 43 1963 399 411
30. K. Sundaram, N. Kumar, and C.W. Bardin 7-alpha-Methyl-nortesosterone (MENT): the optimal androgen for male contraception Ann Med 25 1993 199 205
31. K. Sundaram, N. Kumar, and C.W. Bardin 7alpha-Methyl-19-nortestosterone: an ideal androgen for replacement therapy Rec Progr Horm Res 49 1992 373 376
32. N. Kumar, A.K. Didolkar, A. Ladd, R. Thau, C. Monder, and C.W. Bardin Radioimmunoassay of 7alpha-methyl-19-nortesosterone and investigation of its pharmacokinetics in animals J Steroid Biochem Mol Biol 37 1990 587 591
33. N. Kumar, J. Suvisaari, Y.Y. Tsong, C. Aguillaume, C.W. Bardin, and P. Lähtenmaki Pharmacokinetics of 7alpha-methyl-19-nortestosterone in men and cynomolgous monkeys J Androl 18 1997 352 358
34. N. Kumar, A. Crozat, F. Li, J.F. Catterall, C.W. Bardin, and K. Sundaram 7alpha-Methyl-19-nortestosterone, a synthetic androgen with high potency. Structure-activity comparisons with other androgens J Steroid Biochem Molec Biol 71 1999 213 222
35. G. Noé, J. Suvisaari, C. Martin, A.J. Moo-Young, K. Sundaram, and S.I. Saleh Gonadotrophin and testosterone suppression by 7alpha-methyl-19- nortestosterone acetate administered by subdermal implant to healthy men Hum Reprod 14 1999 2200 2206
36. J. Suvisaari, A. Moo-Young, A. Juhakoski, K. Elomaa, S.I. Saleh, and P. Lähteenmäki Pharmacokinetics of 7alpha-methyl-19-nortestosterone (MENT) delivery using subdermal implants in healthy men Contraception 60 1999 299 303
37. R.A. Anderson, M. Wallace, N. Sattar, N. Kumar, and K. Sundaram Evidence for tissue selectivity of the synthetic androgen 7alpha-methyl-19- nortestosterone in hypogonadal men J Clin Endocrinol Metab 88 2003 2784 2793
38. D.E. Cummings, N. Kumar, C.W. Bardin, K. Sundaram, and W.J. Bremner Prostate-sparing effects in primates of the potent androgen 7alpha-methyl-19- nortesosterone: a potential alternative to testosterone for androgen replacement and male contraception J Clin Endocrinol Metab 83 1998 4212 4219
39. M. Sinnesael, F. Callewaert, M. Morraeels, N. Kumar, R. Sitruk-Ware, and K. Van Proeyen 7alpha-Methyl-19-nortestosterone vs. testosterone implants for hypogonadal osteoporosis: a preclinical study in the aged male orchidectomized rat model Int J Androl 34 2011 i601 i611
40. S. Kelleher, A.J. Conway, and D.J. Handelsman Blood testosterone threshold for androgen deficiency symptoms J Clin Endocrinol Metab 89 2004 3813 3817
41. M. Zitzmann, S. Faber, and E. Nieschlag Association of specific symptoms and metabolic risks with serum testosterone in older men J Clin Endocrinol Metab 91 2006 4335 4343
42. Bayer-Schering Pharma Executive profile of eF-MENT. Non-confidential information 2008
43. S.G. Ramachandra, V. Ramesh, H.N. Krishnamurty, N. Kumar, K. Sundaram, and M.P. Hardy Effect of chronic administration of 7alpha-methyl-19- nortestosterone on serum testosterone, number of spermatozoa and fertility in adult male bonnet monkeys (Macaca radiata) Reproduction 124 2002 301 309
44. S. von Eckardstein, G. Noe, and V. Brache International Committee for Contraception Research, The Population Council. A clinical trial of 7alpha-methyl-19-nortestosterone implants for possible use as a longacting contraceptive for men J Clin Endocrinol Metab 88 2003 5232 5239
45. B.M. Brady, M. Walton, N. Hollow, A.T. Kicman, D.T. Baird, and R.A. Anderson Depot testosterone with etonogestrel implants result in induction of azoospermia in all men for long-term contraception Hum Reprod 19 2004 2658 2667
46. M.J. Walton, N. Kumar, D.T. Baird, H. Ludlow, and R.A. Anderson 7α-Methyl-19-nortestosterone (MENT) vs testosterone in combination with etonogestrel implants for spermatogenic suppression in healthy men J Androl 28 2007 679 688
47. R acetate and levonorgestrel implants (in preparation).