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Claims for Patent: 8,415,332

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Claims for Patent: 8,415,332

Title:Methods of hormonal treatment utilizing ascending-dose extended cycle regimens
Abstract: The present invention provides ascending-dose extended cycle regimens in which a female is administered an estrogen and a progestin for a period of greater than 30 or 31 consecutive days, optionally followed by a hormone-free period or by a period of administration of estrogen. The disclosed regimens can be administered to a female to provide contraceptive and non-contraceptive benefits.
Inventor(s): Diliberti; Charles E. (Montclair, NJ), Reape; Kathleen Z. (Bryn Mawr, PA), Bronnenkant; Lance J. (Snyder, NY)
Assignee: Teva Woman's Health, Inc. (Woodcliff Lake, NJ)
Application Number:11/892,026
Patent Claims: 1. A pharmaceutical kit comprising 83 to 89 daily dosages in sequential order for administration in at least three phases, each daily dosage comprising estrogen and progestin, wherein the daily dosage of estrogen in the first phase is equivalent to 15 .mu.g to 25 .mu.g of ethinyl estradiol, the daily dosage of estrogen in the second phase is equivalent to 20 .mu.g to 30 .mu.g of ethinyl estradiol, and the daily dosage of estrogen in the third phase is equivalent to 25 .mu.g to 35 .mu.g of ethinyl estradiol, wherein the daily dosage of estrogen in the second phase is higher than the daily dosage of estrogen in the first phase, and wherein the dosage of estrogen in the third phase is higher than the daily dosage of estrogen in the second phase.

2. The pharmaceutical kit of claim 1, wherein the daily dosage of progestin in each of the three phases is equivalent to 100 .mu.g to 150 .mu.g of levonorgestrel.

3. The pharmaceutical kit of claim 1, wherein the progestin is selected from the group consisting of levonorgestrel, norethindrone, norethindrone acetate, desogestrel, gestodene, dienogest, norgestimate, cyproterone acetate, norelgestromin, etonogestrel, progesterone, ethynodiol diacetate, norgestrel, trimegestone, medroxyprogesterone acetate, chlormadinone acetate, drospirenone, and esters, conjugates, and prodrugs thereof.

4. The pharmaceutical kit of claim 1, wherein the estrogen is selected from the group consisting of ethinyl estradiol, estradiol, estradiol acetate, estradiol valerate, mestranol, and esters, conjugates, and prodrugs thereof.

5. The pharmaceutical kit of claim 1, further comprising 2 to 8 daily dosages, each of the 2 to 8 daily dosages consisting essentially of estrogen for administration following the administration of the dosages comprising estrogen and progestin.

6. The pharmaceutical kit of claim 5, wherein each of the 2 to 8 daily dosages of estrogen is equivalent to 5 .mu.g to 30 .mu.g of ethinyl estradiol.

7. The pharmaceutical kit of claim 1, wherein the kit contains 35 to 49 daily dosages in the first phase, 14 to 28 daily dosages in the second phase, and 14 to 32 daily dosages in the third phase.

8. The pharmaceutical kit of claim 7, wherein the kit contains 42 daily dosages in the first phase, 21 daily dosages in the second phase, and 21 daily dosages in the third phase.

9. The pharmaceutical kit of claim 8, wherein the daily dosage of estrogen in the first phase is 20 .mu.g of ethinyl estradiol, the daily dosage of estrogen in the second phase is 25 .mu.g of ethinyl estradiol, and daily dosage of estrogen in the third phase is 30 .mu.g of ethinyl estradiol, and wherein the daily dosage of progestin in each of the three phases is 150 .mu.g of levonorgestrel.

10. The pharmaceutical kit of claim 9, further comprising 7 daily dosages, each of the 7 daily dosages consisting essentially of 10 .mu.g of ethinyl estradiol for administration following the dosages comprising estrogen and progestin.

11. The pharmaceutical kit of claim 1, wherein the kit contains 14 to 28 daily dosages in the first phase, 35 to 49 daily dosages in the second phase, and 14 to 32 dosages in the third phase.

12. The pharmaceutical kit of claim 11, wherein the kit contains 21 daily dosages in the first phase, 42 daily dosages in the second phase, and 21 daily dosages in the third phase.

13. The pharmaceutical kit of claim 12, wherein the daily dosage of estrogen in the first phase is 20 .mu.g of ethinyl estradiol, the daily dosage of estrogen in the second phase is 25 .mu.g of ethinyl estradiol, and daily dosage of estrogen in the third phase is 30 .mu.g of ethinyl estradiol, and wherein the daily dosage of progestin in each of the three phases is 150 .mu.g of levonorgestrel.

14. The pharmaceutical kit of claim 13, further comprising 7 daily dosages, each of the 7 daily dosages consisting essentially of 10 .mu.g of ethinyl estradiol for administration following the administration of the dosages comprising estrogen and progestin.

15. The pharmaceutical kit of claim 1, wherein the kit contains 14 to 28 daily dosages in the first phase, 14 to 28 daily dosages in the second phase, and 35 to 53 daily dosages in the third phase.

16. The pharmaceutical kit of claim 15, wherein the kit contains 21 daily dosages in the first phase, 21 daily dosages in the second phase, and 42 daily dosages in the third phase.

17. The pharmaceutical kit of claim 16, wherein the daily dosage of estrogen in the first phase is 20 .mu.g of ethinyl estradiol, the daily dosage of estrogen in the second phase is 25 .mu.g of ethinyl estradiol, and daily dosage of estrogen in the third phase is 30 .mu.g of ethinyl estradiol, and wherein the daily dosage of progestin in each of the three phases is 150 .mu.g of levonorgestrel.

18. The pharmaceutical kit of claim 17, further comprising 7 daily dosages, each of the 7 daily dosages consisting essentially of 10 .mu.g of ethinyl estradiol for administration following the administration of the dosages comprising estrogen and progestin.
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