Claims
- 1. A method of improving health in a woman having an elevated or substantially elevated level of sex hormone binding globulin (SHBG) comprising non-orally administering an androgenic steroid in an amount sufficient to provide a therapeutic effect in the presence of elevated or substantially elevated SHBG levels.
- 2. The method of claim 1, wherein the woman is receiving oral estrogen supplementation.
- 3. The method of claim 2, wherein the oral estrogen and the non-oral androgenic steroid are coadministered.
- 4. The method of claim 2, wherein said androgenic steroid is a member selected from the group consisting of: testosterone, methyltestosterone, androstenedione, adrenosterone, dehydroepiandrosterone, oxymetholone, fluoxymesterone, methandrostenolone, testolactone, pregnenolone, 17α-methylnortestosterone, norethandrolone, dihydrotestosterone, danazol, oxymetholone, androsterone, nandrolone, stanozolol, ethylestrenol, oxandrolone, bolasterone and mesterolone, testosterone propionate, testosterone cypionate, testosterone phenylacetate, testosterone enanthate, testosterone acetate, testosterone buciclate, testosterone heptanoate, testosterone decanoate, testosterone caprate, testosterone isocaprate, isomers and derivatives thereof, and a combination thereof.
- 5. The method of clam 2, wherein said androgenic steroid is a member selected from the group consisting of: testosterone, dihydrotestosterone, methyltestosterone, isomers and derivatives thereof, and a combination thereof.
- 6. The method of claim 2, wherein said androgenic steroid is administered in a dosage sufficient to achieve a therapeutic effect equivalent to a total testosterone serum level of from about 15 to about 1000 ng/dl.
- 7. The method of claim 6, wherein said androgenic steroid dosage is sufficient to achieve a therapeutic effect equivalent to a total testosterone serum level of from about 85 to about 1000 ng/dl.
- 8. The method of claim 6, wherein said androgenic steroid dosage is sufficient to achieve a therapeutic effect equivalent to a total testosterone serum level of from about 100 to about 1000 ng/dl.
- 9. The method of claim 2, wherein said androgenic steroid is administered in a dosage sufficient to achieve a therapeutic effect equivalent to a free testosterone serum level of from about 0.5 to about 30 pg/ml.
- 10. The method of claim 9, wherein said androgenic steroid dosage is sufficient to achieve a therapeutic effect equivalent to a free testosterone serum level of from about 1 to about 15 pg/mL.
- 11. The method of claim 9, wherein said androgenic steroid dosage is sufficient to achieve a therapeutic effect equivalent to a free testosterone serum level of from about 3 to about 10 pg/ml.
- 12. The method of claim 9, wherein said androgenic steroid dosage is sufficient to achieve a therapeutic effect equivalent to a free testosterone serum level of about 1 to about 7 pg/ml.
- 13. The method of claim 2, wherein said androgenic steroid is administered in a dosage sufficient to achieve a therapeutic effect equivalent to a bioavailable testosterone serum level of from about 1 to about 70 ng/dl.
- 14. The method of claim 13, wherein said androgenic steroid dosage is sufficient to achieve a therapeutic effect equivalent to a bioavailable testosterone serum level of from about 2 to about 35 ng/dl.
- 15. The method of claim 13, wherein said androgenic steroid dosage is sufficient to achieve a therapeutic effect equivalent to a bioavailable testosterone serum level of from about 2 to about 13 ng/dl.
- 16. The method of claim 2, wherein said androgenic steroid is administered in a dosage sufficient to achieve a therapeutic effect equivalent to a testosterone dosage of at least about 50 mcg/day.
- 17. The method of claim 16, wherein said androgenic steroid is administered in a dosage sufficient to achieve a therapeutic effect equivalent to a testosterone dosage of from about 75 to about 3000 mcg/day.
- 18. The method of claim 16, wherein said androgenic steroid is administered in a dosage sufficient to achieve a therapeutic effect equivalent to a testosterone dosage of from about 500 to about 2500 mcg/day.
- 19. The method of claim 16, wherein said androgenic steroid is administered in a dosage sufficient to achieve a therapeutic effect equivalent to a testosterone dosage of from about 550 to about 2000 mcg/day.
- 20. The method of claim 2, wherein said non-oral administration is topical administration, or parenteral administration, or a combination thereof.
- 21. The method of claim 20, wherein said parenteral administration is intramuscular injection, or subcutaneous implantation, or a combination thereof.
- 22. The method of claim 20, wherein said topical administration is transdermal, transmucosal, or sublingual, or a combination thereof.
- 23. The method of claim 2, wherein said improved health is manifest by restoration, enhancement, or improvement of a characteristic selected from the group consisting of: sexual desire, stimulation to sexual organs, ability to achieve orgasm, pleasure in sexual activity, frequency of sexual activity, vital energy, sense of well-being, mood and sense of emotional well being, shyness, cognitive abilities, muscle mass and function, body composition, bone mineral density, skin and hair condition, pubic hair, urogenital atrophy, vaginal dryness, dry eyes, health in autoimmune conditions, vasomotor instability, breast tenderness, symptoms of premenstrual syndrome, and a combination thereof.
- 24. The method of claim 2, wherein said estrogen is administered in a dosage sufficient to achieve a therapeutic effect equivalent to a conjugated equine estrogen dosage of from about 0.2 to about 3.0 mg/day.
- 25. The method of claim 2, wherein said orally administered estrogen is a member selected from the group consisting of: 17β-estradiol, 17α-estradiol, conjugated equine estrogen, esterified estrogen, micronized estradiol, sodium estrogen sulfate, ethinyl estradiol, estrone, tibolone, selective estrogen receptor modulator (SERM), phytoestrogen, isomers and derivatives thereof, and a combination thereof.
- 26. The method of claim 2, wherein said orally administered estrogen is a conjugated equine estrogen.
- 27. The method of claim 2, wherein said orally administered estrogen is an esterified estrogen.
- 28. The method of claim 2, wherein said orally administered estrogen is micronized estradiol.
- 29. The method of claim 2, further comprising administering an effective amount of a progestin sufficient to provide endometrial safety.
- 30. The method of claim 2, further comprising administering an amount of progestin sufficient to provide effective contraception.
- 31. A kit for improving the health of a woman having an elevated, or substantially elevated level of sex hormone binding globulin (SHBG), comprising a non-oral dosage form of an androgenic steroid, in an amount sufficient to provide a therapeutic effect in the presence of elevated, or substantially elevated SHBG levels.
- 32. The kit of claim 31, wherein said androgenic steroid is a member selected from the group consisting of: testosterone, methyltestosterone, androstenedione, adrenosterone, dehydroepiandrosterone, oxymetholone, fluoxymesterone, methandrostenolone, testolactone, pregnenolone, 17α-methylnortestosterone, norethandrolone, dihydrotestosterone, danazol, oxymetholone, androsterone, nandrolone, stanozolol, ethylestrenol, oxandrolone, bolasterone and mesterolone, testosterone propionate, testosterone cypionate, testosterone phenylacetate, testosterone enanthate, testosterone acetate, testosterone buciclate, testosterone heptanoate, testosterone decanoate, testosterone caprate, testosterone isocaprate, isomers and derivatives thereof, and a combination thereof.
- 33. The kit of claim 31, wherein said androgenic steroid is present in a non-oral dosage form sufficient to achieve a therapeutic effect equivalent to a total testosterone serum level of from about 15 to about 1000 ng/dl.
- 34. The kit of claim 31, wherein said androgenic steroid is present in a non-oral dosage form sufficient to achieve a therapeutic effect equivalent to a free testosterone serum level of from about 0.5 to about 30 pg/ml.
- 35. The kit of claim 31, wherein said androgenic steroid is present in a non-oral dosage form sufficient to achieve a therapeutic effect equivalent to a bioavailable testosterone serum level of from about 1 to about 70 ng/dl.
- 36. The kit of claim 31, wherein said androgenic steroid is present in a non-oral dosage form sufficient to achieve a therapeutic effect equivalent to a testosterone dosage of at least about 50 mcg/day.
- 37. The kit of claim 31, wherein said non-oral dosage form is a topical or parenteral dosage form, or a combination thereof.
- 38. The kit of claim 31, further comprising an effective amount of an estrogen in an oral dosage form.
- 39. The kit of claim 38, wherein said estrogen is present in a dosage form sufficient to achieve a therapeutic effect equivalent to a conjugated equine estrogen dosage of from about 0.2 to about 3.0 mg/day.
- 40. The kit of claim 38, wherein said estrogen is a member selected from the group consisting of: 17α-estradiol, 17β-estradiol, conjugated equine estrogen, esterified estrogen, micronized estradiol, sodium estrogen sulfate, ethinyl estradiol, estrone, selective estrogen receptor modulator (SERM), phytoestrogen, isomers and derivatives thereof, and a combination thereof.
- 41. The kit of claim 38, further comprising an effective amount of a progestin sufficient to provide endometrial safety.
- 42. The kit of claim 38, further comprising an effective amount of a progestin sufficient to provide effective contraception.
RELATED APPLICATIONS
[0001] This application claims priority to United States Provisional Patent Applications Serial No. 60/138,851; Serial No. 60/138,854, and Serial No.:60/139,323, each of which was filed on Jun. 11, 1999. Each of these applications is hereby incorporated by reference.
Provisional Applications (3)
|
Number |
Date |
Country |
|
60138851 |
Jun 1999 |
US |
|
60138854 |
Jun 1999 |
US |
|
60139323 |
Jun 1999 |
US |
Continuations (1)
|
Number |
Date |
Country |
Parent |
09591141 |
Jun 2000 |
US |
Child |
10278033 |
Oct 2002 |
US |