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Claims for Patent: 8,450,299

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Claims for Patent: 8,450,299

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 Womans's Health, Inc. (Woodcliff Lake, NJ)
Application Number:13/492,138
Patent Claims: 1. A method of contraception, the method comprising: administering to a female in need thereof a dosage comprising estrogen and progestin for a period of 83 to 89 consecutive days, wherein the dosage comprising estrogen and progestin is administered in at least three phases, 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 daily dosage of estrogen in the third phase is higher than the daily dosage of estrogen in the second phase.

2. The method 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 levonorgestrel.

3. The method 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 method 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 method of claim 1, further comprising administering to the female a daily dosage consisting essentially of estrogen for a period of 2 to 8 consecutive days following the administration of the dosage comprising estrogen and progestin for 83 to 89 consecutive days.

6. The method of claim 5, wherein the daily dosage of estrogen that is administered for a period of 2 to 8 consecutive days is 5 .mu.g to 30 .mu.g of ethinyl estradiol.

7. The method of claim 5, further comprising administering an additional active agent that is administered (i) in combination with the dosage consisting essentially of estrogen for a period of 2 to 8 consecutive days following the administration of the dosage comprising estrogen and progestin for 83 to 89 consecutive days, (ii) continuously, (iii) intermittently, (iv) one time, or (v) once weekly.

8. The method of claim 1, wherein the female is also treated for acne, headache or pelvic pain.

9. The method of claim 1, wherein the first phase is 35 to 49 days, the second phase is 14 to 28 days, and the third phase is 14 to 32 days.

10. The method of claim 9, wherein the first phase is 42 days, the second phase is 21 days, and the third phase is 21 days.

11. The method of claim 10, 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 the 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.

12. The method of claim 11, further comprising administering to the female a daily dosage consisting essentially of 10 .mu.g of ethinyl estradiol for 7 consecutive days following the administration of the dosage comprising estrogen and progestin.

13. The method of claim 1, wherein the first phase is 14 to 28 days, the second phase is 35 to 49 days, and the third phase is 14 to 32 days.

14. The method of claim 13, wherein the first phase is 21 days, the second phase is 42 days, and the third phase is 21 days.

15. The method of claim 14, 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 the 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.

16. The method of claim 15, further comprising administering to the female a daily dosage consisting essentially of 10 .mu.g of ethinyl estradiol for 7 consecutive days following the administration of the dosage comprising estrogen and progestin.

17. The method of claim 1, wherein the first phase is 14 to 28 days, the second phase is 14 to 28 days, and the third phase is 35 to 53 days.

18. The method of claim 17, wherein the first phase is 21 days, the second phase is 21 days, and the third phase is 42 days.

19. The method of claim 18, 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 the 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.

20. The method of claim 19, further comprising administering to the female a daily dosage consisting essentially of 10 .mu.g of ethinyl estradiol for 7 consecutive days following the administration of the dosage comprising estrogen and progestin.
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