Combined pharmaceutical estrogen-androgen-progestin
First Claim
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1. A pharmaceutical composition for contraception or hormone replacement therapy, said composition comprising a hormonal component, wherein the hormonal component consists of an estrogen, a progestin and an androgen, and wherein the estrogen concentration is from about 5 micrograms to about 35 micrograms per daily dose.
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Abstract
Disclosed are methods and compositions for oral contraception and for hormone replacement therapy. Certain compositions of the invention contain androgens, preferably methyltestosterone to be taken in conjunction with estrogens and progestins.
120 Citations
39 Claims
- 1. A pharmaceutical composition for contraception or hormone replacement therapy, said composition comprising a hormonal component, wherein the hormonal component consists of an estrogen, a progestin and an androgen, and wherein the estrogen concentration is from about 5 micrograms to about 35 micrograms per daily dose.
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15. A pharmacetical composition comprising a hormonal component, wherein the hormonal component consists essentially of:
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an estrogen having estrogenic activity equivalent to from about 5 micrograms to about 35 micrograms ethinyl estradiol; a progestin having progestogenic activity equivalent to from about 0.030 milligrams to about 0.2 milligrams levonorgestrel; and an androgen having androgenic activity equivalent to from about 0.1 Imilligrams to about 1.5 milligrams methyltestosterone per daily dose. - View Dependent Claims (16, 17, 18)
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19. A pharmaceutical composition comprising 5 micrograms ethinyl estradiol, 25 micrograms levonorgestrel and 0.25 milligrams methyltestosterone per daily dose.
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20. A pharmaceutical composition comprising 5 micrograms ethinyl estradiol, 50 micrograms levonorgestrel and 0.5 milligrams methyltestosterone per daily dose.
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21. A pharmaceutical composition comprising 10 micrograms ethinyl estradiol, 50 micrograms levonorgestrel and 0.5 milligrams methyltestosterone per daily dose.
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22. A pharmaceutical composition comprising 10 micrograms ethinyl estradiol, 100 micrograms levonorgestrel and 1 milligram methyltestosterone per daily dose.
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23. A pharmaceutical composition comprising 20 micrograms ethinyl estradiol, 100 micrograms levonorgestrel and 0.5 milligrams methyltestosterone per daily dose.
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24. A pharmaceutical composition comprising 20 micrograms ethinyl estradiol, 100 micrograms levonorgestrel and 1 milligram methyltestosterone per daily dose.
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25. An oral contraceptive preparation comprising:
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(a) a composition comprising methyltestosterone, levonorgestrel and from about 5 to about 18 micrograms of ethinyl estradiol to be administered daily on consecutive days of a portion of a menstrual cycle; and (b) a composition comprising levonorgestrel and ethinyl estradiol to be administered daily on consecutive days of a portion of a menstrual cycle. - View Dependent Claims (26, 27, 28)
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- 29. A method of replacing the natural estrogen to androgen balance in a female in need of estrogen therapy, wherein the method comprises administering to the female a pharmaceutical composition comprising a hormonal component, wherein the hormones in the hormonal component are from about 5 to about 30 micrograms of ethinyl estradiol per dialy dose, a progestin and an androgen.
Specification