Treating androgen deprivation therapy induced hot flashes and bone loss in men using cis-clomiphene
This invention provides: 1) a method of treating androgen-deprivation induced osteoporosis, bone fractures, loss of bone mineral density (BMD), and/or hot flashes in a male subject suffering from prostate cancer; 2) a method of preventing androgen-deprivation induced osteoporosis, bone fractures, loss of bone mineral density (BMD), and/or hot flashes in a male subject suffering from prostate cancer; 3) a method of suppressing or inhibiting androgen-deprivation induced osteoporosis, bone fractures, loss of bone mineral density (BMD), and/or hot flashes in a male subject suffering from prostate cancer; and 4) a method of reducing the risk of developing androgen-deprivation induced osteoporosis, bone fractures, loss of bone mineral density (BMD), and/or hot flashes in a male subject suffering from prostate cancer, by administering to the subject a pharmaceutical composition comprising cis-clomiphene or a pharmaceutically acceptable salt thereof.
1. A method of treating loss of bone mineral density (BMD) in a male subject suffering therefrom, said method comprising the step of orally administering to said male subject an effective amount therefor of a pharmaceutical composition comprising (A) cis-clomiphene or a pharmaceutically acceptable salt thereof and (B) less than 10% by weight of trans-clomiphene or a pharmaceutically acceptable salt thereof, wherein said less than 10% by weight is based on a total weight of (A)+(B).
2. The method according to claim 1 , wherein said pharmaceutical composition is a pellet, a tablet, a capsule, a solution, a suspension, an emulsion, an elixir, or a gel.
3. A method of suppressing, inhibiting or reducing the risk of loss of bone mineral density to a male subject undergoing androgen-deprivation therapy, said method comprising the step of orally administering to said male subject an effective amount therefor of a pharmaceutical composition comprising (A) cis-clomiphene or a pharmaceutically acceptable salt thereof and (B) less than 10% by weight of trans-clomiphene or a pharmaceutically acceptable salt thereof, wherein said less than 10% by weight is based on a total weight of (A)+(B).
4. The method according to claim 3 , wherein said pharmaceutical composition is a pellet, a tablet, a capsule, a solution, a suspension, an emulsion, an elixir, or a gel.
5. The method according to claim 1 , wherein the pharmaceutical composition comprises less than 5% by weight of trans-clomiphene or a pharmaceutically acceptable salt thereof, wherein said less than 5% by weight is based on a total weight of (A)+(B).
6. The method according to claim 5 , wherein the pharmaceutical composition comprises less than 2% by weight of trans-clomiphene or a pharmaceutically acceptable salt thereof, wherein said less than 2% by weight is based on a total weight of (A)+(B).
7. The method according to claim 6 , wherein said pharmaceutical composition is a tablet.
8. The method according to claim 7 , wherein the cis-clomiphene or pharmaceutically acceptable salt thereof is cis-clomiphene citrate.
9. The method according to claim 6 , wherein said pharmaceutical composition is a hard or soft gelatin capsule.
10. The method according to claim 9 , wherein the cis-clomiphene or pharmaceutically acceptable salt thereof is cis-clomiphene citrate.
11. The method according to claim 1 , wherein the pharmaceutical composition further comprises at least one additional therapeutic agent selected from the group consisting of luteinizing-hormone releasing hormone (LHRH) agonists and antagonists.
12. The method according to claim 1 , wherein the male additionally suffers from osteoporosis and/or bone fractures.
13. The method according to claim 3 , wherein the pharmaceutical composition comprises less than 5% by weight of trans-clomiphene or a pharmaceutically acceptable salt thereof, wherein said less than 5% by weight is based on a total weight of (A)+(B).
14. The method according to claim 13 , wherein the pharmaceutical composition comprises less than 2% by weight of trans-clomiphene or a pharmaceutically acceptable salt thereof, wherein said less than 2% by weight is based on a total weight of (A)+(B).
15. The method according to claim 14 , wherein said pharmaceutical composition is a tablet.
16. The method according to claim 15 , wherein the cis-clomiphene or pharmaceutically acceptable salt thereof is cis-clomiphene citrate.
17. The method according to claim 14 , wherein said pharmaceutical composition is a hard or soft gelatin capsule.
18. The method according to claim 17 , wherein the cis-clomiphene or pharmaceutically acceptable salt thereof is cis-clomiphene citrate.
19. The method according to claim 3 , wherein the pharmaceutical composition further comprises at least one additional therapeutic agent selected from the group consisting of luteinizing-hormone releasing hormone (LHRH) agonists and antagonists.
20. The method according to claim 3 , wherein the male additionally suffers from osteoporosis and/or bone fractures.
21. A method of suppressing or inhibiting loss of bone mineral density in a male patient undergoing androgen deprivation therapy for the treatment of prostate cancer, said method comprising the step of orally administering to said subject an effective amount therefor of a pharmaceutical composition comprising (A) cis-clomiphene or a pharmaceutically acceptable salt thereof and (B) less than 10% by weight of trans-clomiphene or a pharmaceutically acceptable salt thereof, wherein said less than 10% by weight is based on a total weight of (A)+(B).
22. The method according to claim 21 , wherein the male additionally suffers from osteoporosis and/or bone fractures.
23. The method according to claim 21 , wherein the pharmaceutical composition further comprises at least one additional therapeutic agent selected from the group consisting of luteinizing-hormone releasing hormone (LHRH) agonists and antagonists.
24. The method according to claim 21 , wherein the pharmaceutical composition comprises less than 5% by weight of trans-clomiphene or a pharmaceutically acceptable salt thereof, wherein said less than 5% by weight is based on a total weight of (A)+(B).
25. The method according to claim 24 , wherein the pharmaceutical composition comprises less than 2% by weight of trans-clomiphene or a pharmaceutically acceptable salt thereof, wherein said less than 2% by weight is based on a total weight of (A)+(B).
26. The method according to claim 25 , wherein said pharmaceutical composition is a tablet.
27. The method according to claim 26 , wherein the cis-clomiphene or pharmaceutically acceptable salt thereof is cis-clomiphene citrate.
28. The method according to claim 25 , wherein said pharmaceutical composition is a hard or soft gelatin capsule.
29. The method according to claim 28 , wherein the cis-clomiphene or pharmaceutically acceptable salt thereof is cis-clomiphene citrate.
30. The method according to claim 21 , which comprises orally administering to said male said pharmaceutical composition comprising less than 5% by weight of trans-clomiphene or a pharmaceutically acceptable salt thereof, wherein said less than 5% by weight is based on the total weight of (A)+(B), wherein said administering is optionally along with at least one additional therapeutic agent selected from the group consisting of luteinizing-hormone releasing hormone (LHRH) agonists and antagonists, wherein optionally the male additionally suffers from osteoporosis and/or bone fractures.
31. The method according to claim 30 , wherein the pharmaceutical composition comprises less than 2% by weight of trans-clomiphene or a pharmaceutically acceptable salt thereof, wherein said less than 2% by weight is based on a total weight of (A)+(B).