Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
2006-04-11
2006-04-11
Hartley, Michael (Department: 1618)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C424S400000, C424S443000, C514S170000
Reexamination Certificate
active
07025979
ABSTRACT:
A formulation for male contraception comprising a progestin possessing both estrogenic and androgenic properties is remarkably effective for spermatogenesis suppression in males. The progestin Norethisterone (NET), particularly its derivatives Norethisterone acetate and Norethisterone enanthate in sufficient doses induce oligozoospermia or azoospermia in males. Formulations further comprising an androgen, such as a testosterone derivative such as a testosterone ester, particularly testosterone undecanoate, are especially effective male contraceptive formulations.
REFERENCES:
patent: 4018919 (1977-04-01), Black
patent: 4210644 (1980-07-01), Ewing et al.
patent: 5035891 (1991-07-01), Runkel et al.
patent: 5583129 (1996-12-01), Spona et al.
patent: 5633242 (1997-05-01), Oettel et al.
patent: 5711962 (1998-01-01), Cordes et al.
patent: 5811117 (1998-09-01), Hashimoto et al.
patent: 5855905 (1999-01-01), Oettel et al.
patent: RE36247 (1999-07-01), Plunkett et al.
patent: 5965552 (1999-10-01), Berliner et al.
patent: 27 14 240 (1977-10-01), None
patent: 196 50 352 (1998-07-01), None
patent: 0 773 028 (1997-05-01), None
patent: WO 95/12383 (1995-05-01), None
Guerin et al., “Inhibition of spermatogenesis in men using various combinations of oral progestagens and percutaneous or oral androgens.” International Journal of Andrology, vol. 11, pp. 187-199, 1988.
E. Nieschlag et al., “Testosterone Therapy,”Male Reproductive Health and Dysfunction, pp. 297-309 (1997).
Beatrize Couzinet et al., “The Antigonadotropic Activity of Progestins (19-Nortestosterone and 19-Norprogestosterone Derivatives) Is not Mediated through the Androgen Recpetor,”Journal of Clinical Endocrinology and Metabolism, 81, No. 12, pp. 4218-4223 (1996).
M.A. Okon et al., “A prospective randomized controlled study comparing the morphological and biochemical responses to the endometrium to two different forms of “period free” hormone replacement therapy,”Human Reproduction, 31, No. 8, pp. 2261-2265 (1998).
J.F. Guerin et al., “Inhibition of spermatogenesis in men using various combinations of oral progestagens and percutaneous or oral androgens,”International Journal of Andrology, 11, pp. 187-199 (1988).
M.C. Merrigiola et al., “Low Dose of Cyproterone acetate and testosterone enanthate for contraception in men”Human Reproduction, 13, pp. 1225-1229 (1998).
Eds. Nieschlag E. Behre HM, “Experimental Approaches,”Hormone Male Contraception Andrology—Male reproductive Health and Dysfunction, pp. 388-393 (1997).
F. Neuman et al., “Androgens II and Anti-Androgens,”Springer-Verlag, Berlin, Heidelberg, pp. 436-437 (1974).
Fuhrmann et al., “Stable transfection of androgen recpetor and MMTV-CAT into mammalian cells: inhibition of cat expression by anti-androgens,”J. Steroid Biochem. Mol. Biol., 42(8), p. 787 (1992).
K.H. Fritzemeier et al., “In Vitro and In Vivo Models to Characterize Estrogens and Antiestrogens,”Handbook of Experimental Pharmacology, vol. 135, pp. 6-43 (1999).
E. Nieschlag et al., “Testosterone in male contraception,”Testosterone: action, deficiency, substitution, pp. 513-528 (1998).
H.M. Behre et al., “Potential of Testosterone Buciclate for Male Contraception: Endocrine Differences between Responders and Nonresponders,”Journal of Clinical Endocrinology and Metabolism, 80, No. 8, pp. 2394-2403 (1995).
M.C. Merrigiola et al., “A combined regimen of cyproterone acetate and testosterone enanthate as a potentially highly effective male contraceptive,”Journal of Clinical Endocrinology and Metabolism, 81, pp. 3018-3023 (1996).
R.A. Bebb, “Combined administration of levonorgestrel and testosterone induces more rapid and effective suppression of spermatogenesis than testosterone alone: a promising male contraceptive approach,”Journal of Clinical Endocrinology and Metabolism, 81, pp. 757-762 (1996).
C.J. Bagatell et al., “Comparison of a Gonadotropin releasing-hormone antagonist plus testosterone (T) versus T alone as potential male contraceptive regimens,”Journal of Clinical Endocrinology and Metabolism, 77, No. 2, pp. 427-432 (1997).
M.C. Merrigiola et al., “An oral regimen of cyproterone acetate and testosterone undecanoate for spermatogenic suppression in men,”Fertility and Sterility, 68, pp. 84-850 (1997).
World Health Organization, “Contraceptive efficacy of testosterone-induced azoospermia and oligozoospermia in normal men,”Fertility and Sterility, 65, pp. 84-850 (1997).
D.Buechter et al., “Clinical trial of transdermal testosterone and oral levonorgestrel for male contraception,”0The Journal of Clinical Endocrinology&Metabolism84, No. 4, pp. 1244-1249 (1999).
English Abstract of WO96/03131 dated Feb. 8, 1996.
World Health Organization, “Contraceptive efficacy of testosterone-induced azoospermia in normal men,”The Lancet, 336, pp. 955-959 (1990).
Born et al., “Investigations upon the mechanism of inhibition of spermatogenesis in the rat by a dimeric ethynodiol-testosterone ester,”Acta Endocrinologica(Copenh), 1988, 117, pp. 536-544.
Sánchez et al., “Inhibition of Spermatogenesis with Monthly Injections of Medroxyprogesterone Acetate and Low Dose Testosterone Enanthate,”International Journal of Andrology, 2(1979), pp. 136-149.
Habenicht Ursula-Friederike
Kamischke Axel
Nieschlag Eberhard
Oettel Michael
Ruebig Alexander
Hartley Michael
Millen White Zelano & Branigan P.C.
Oh Simon J.
Schering AG
LandOfFree
Male contraceptive formulation comprising norethisterone does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Male contraceptive formulation comprising norethisterone, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Male contraceptive formulation comprising norethisterone will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3532192