Claims for Patent: 10,548,903

Summary for Patent: 10,548,903

Title:	Treatment of male androgen deficiency symptoms or diseases with sex steroid precursor combined with SERM
Abstract:	Novel methods for prevention, reduction or elimination of the incidence of male androgen deficiency symptoms or diseases including male hypogonadism-associated symptoms and diseases associated with low serum testosterone and/or low DHEA or low total androgens in susceptible warm-blooded animals including humans involving administration of an amount of a sex steroid precursor, particularly dehydroepiandrosterone (DHEA) and a selective estrogen receptor modulator (SERM) (particularly acolbifene), an antiestrogen or a prodrug of the two. The symptoms or diseases are loss of libido, erectile dysfunction, tiredness, loss of energy, depression, bone loss, muscle loss, muscle weakness, fat accumulation, memory loss, cognition loss, Alzheimer\'s disease, dementia, loss of body hair, fertility problems, insomnia, gynecomastia, anemia, hot flushes, sweats, decreased sense of well-being, obesity, osteoporosis, hypercholesterolemia, hyperlipidemia, atherosclerosis, hypertension, insulin resistance, cardiovascular disease and type 2 diabetes. Pharmaceutical compositions for delivery of active ingredient(s) and kit(s) useful to the invention are also disclosed.
Inventor(s):	Labrie; Fernand (Quebec, CA), Gauthier; Sylvain (St-Augustin-de-Desmaures, CA)
Assignee:	Endorecherche, Inc. (CA)
Application Number:	15/626,774
Patent Claims:	1. A method of reducing the incidence of male androgen deficiency symptoms or diseases, said method comprising administering to an aging male patient in need of said prevention, wherein said aging male patient has functional adrenals and testis, (i) a therapeutically effective amount of a sex steroid precursor or prodrug thereof in association with (ii) a therapeutically effective amount of a selective estrogen receptor modulator or prodrug thereof, wherein the selective estrogen receptor modulator stimulates LH secretion which increases the level of circulating testosterone, wherein the selective estrogen receptor modulator is acolbifene: ##STR00014## and is an optically active compound having an absolute configuration S on carbon 2; and wherein the sex steroid precursor is dehydroepiandrosterone, wherein non-symptomatic patients initially selected to undergo said method have values of serum testosterone below 3.0 ng/mL and/or values of serum dehydroepiandrosterone below 2.0 ng/mL. 2. The method of claim 1, wherein the symptoms or diseases are selected from the group comprising of loss of libido, erectile dysfunction, tiredness, loss of energy, depression, bone loss, muscle loss, muscle weakness, fat accumulation, memory loss, cognition loss, Alzheimer's disease, dementia, loss of body hair, fertility problems, insomnia, gynecomastia, anemia, hot flushes, sweats, decreased sense of well-being, obesity, osteoporosis, hypercholesterolemia, hyperlipidemia, atherosclerosis, hypertension, insulin resistance, cardiovascular disease and type 2 diabetes. 3. The method of claim 1, wherein the selective estrogen receptor modulator has no estrogenic activity in breast, uterine or endometrial tissues. 4. The method of claim 1, which reduces the risk of the male patients acquiring breast cancer. 5. The method of claim 1, further comprising administering as part of a combination therapy, a therapeutically effective amount of human chorionic gonadotropin. 6. The method of claim 1, wherein the selective estrogen receptor modulator and/or sex steroid precursor are/is rectally administered. 7. The method of claim 1, wherein the selective estrogen receptor modulator and/or sex steroid precursor are/is orally administered. 8. The method of claim 1, wherein the selective estrogen receptor modulator and/or sex steroid precursor are/is percutaneously administered. 9. The method of claim 2, wherein the symptom or disease is loss of libido. 10. The method of claim 2, wherein the symptom or disease is erectile dysfunction. 11. The method of claim 2, wherein the symptom or disease is tiredness. 12. The method of claim 2, wherein the symptom or disease is loss of energy. 13. The method of claim 2, wherein the symptom or disease is depression. 14. The method of claim 2, wherein the symptom or disease is bone loss. 15. The method of claim 2, wherein the symptom or disease is muscle loss. 16. The method of claim 2, wherein the symptom or disease is muscle weakness. 17. The method of claim 2, wherein the symptom or disease is fat accumulation. 18. The method of claim 2, wherein the symptom or disease is memory loss. 19. The method of claim 2, wherein the symptom or disease is cognition loss. 20. The method of claim 2, wherein the symptom or disease is Alzheimer's disease. 21. The method of claim 2, wherein the symptom or disease is dementia. 22. The method of claim 2, wherein the symptom or disease is loss of body hair. 23. The method of claim 2, wherein the symptom or disease is fertility problems. 24. The method of claim 2, wherein the symptom or disease is insomnia. 25. The method of claim 2, wherein the symptom or disease is gynecomastia. 26. The method of claim 2, wherein the symptom or disease is anemia. 27. The method of claim 2, wherein the symptom or disease is hot flushes. 28. The method of claim 2, wherein the symptom or disease is sweats. 29. The method of claim 2, wherein the symptom or disease is decreased sense of well-being. 30. The method of claim 2, wherein the symptom or disease is obesity. 31. The method of claim 2, wherein the symptom or disease is osteoporosis. 32. The method of claim 2, wherein the symptom or disease is hypercholesterolemia. 33. The method of claim 2, wherein the symptom or disease is hyperlipidemia. 34. The method of claim 2, wherein the symptom or disease is atherosclerosis. 35. The method of claim 2, wherein the symptom or disease is hypertension. 36. The method of claim 2, wherein the symptom or disease is insulin resistance. 37. The method of claim 2, wherein the symptom or disease is cardiovascular disease. 38. The method of claim 2, wherein the symptom or disease is type 2 diabetes. 39. The method of claim 1, wherein the male androgen deficiency symptoms or diseases are associated with male hypogonadism.

Details for Patent 10,548,903

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	January 15, 1974	10,548,903	2034-03-10
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	December 27, 1984	10,548,903	2034-03-10
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 15, 1985	10,548,903	2034-03-10
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 16, 1990	10,548,903	2034-03-10
Bel-mar Laboratories, Inc.	CHORIONIC GONADOTROPIN	chorionic gonadotropin	Injection	017054	March 26, 1974	10,548,903	2034-03-10