Regimens for Treatment of Conditions Related to Estrogen Deficiency

1 . A method of stimulating estrogen production in a pre-menopausal or peri-menopausal female in need thereof, the method comprising administering to the female a combination of estrogen and progestin for a period of 21 or more consecutive days, immediately followed by a hormone-free period of 11 or more consecutive days.

2 . The method of claim 1 , wherein the combination of estrogen and progestin is administered for a period of 21 to 119 consecutive days.

3 . The method of claim 1 , wherein the combination of estrogen and progestin is administered for a period of 21 to 91 consecutive days.

4 . The method of claim 1 , wherein the hormone-free period is 11 days to 91 days.

5 . The method of claim 1 , wherein the estrogen that is administered in combination with the progestin for a period of 21 or more consecutive days is administered in a daily amount equivalent to about 10 μg to about 50 μg of ethinyl estradiol, and the progestin that is administered in combination with estrogen for a period of 21 or more consecutive days is administered in a daily amount equivalent to about 0.05 mg to about 0.5 mg of levonorgestrel.

6 . The method of claim 1 , wherein the estrogen that is administered in combination with the progestin for a period of 21 or more consecutive days is administered by an oral tablet.

7 . The method of claim 1 , wherein the progestin that is administered in combination with the estrogen for a period of 21 or more consecutive days is administered by an oral tablet.

8 . The method of claim 1 , wherein the combination of progestin and estrogen that is administered for a period of 21 or more consecutive days is administered by an oral tablet.

9 . The method of claim 1 , wherein the hormone-free period is immediately followed by a combination of estrogen and progestin for a period of 21 or more consecutive days, immediately followed by a hormone-free period of 11 or more consecutive days.

10 . The method of claim 1 , further comprising the female having free estradiol levels of about 40 to about 150 pg/ml during early follicular phase of a female's menstrual cycle following the administration of estrogen and progestin and during the hormone-free period.

11 . The method of claim 1 , further comprising the female having free estradiol levels of about 40 to about 350 pg/ml during late follicular phase of a female's menstrual cycle following the administration of estrogen and progestin and during the hormone-free period.

12 . The method of claim 1 , further comprising the female having free estradiol levels of about 150 to about 750 pg/ml during luteal phase of a female's menstrual cycle following the administration of estrogen and progestin and during the hormone-free period.

13 . A method of stimulating estrogen production in a pre-menopausal or peri-menopausal female in need thereof, the method comprising administering to the female a combination of estrogen and progestin for a period of 21 or more consecutive days, immediately followed by administration of estrogen without progestin for a period of 1 to 14 consecutive days, and then immediately followed by a hormone-free period of 11 to 91 consecutive days.

14 . The method of claim 13 , wherein the combination of estrogen and progestin is administered for a period of 21 to 119 consecutive days.

15 . The method of claim 13 , wherein the combination of estrogen and progestin is administered for a period of 21 to 91 consecutive days.

16 . The method of claim 13 , wherein the hormone-free period is 14 days to 91 days.

17 . The method of claim 13 , wherein the estrogen that is administered in combination with the progestin for a period of 21 or more consecutive days is administered in a daily amount equivalent to about 10 μg to about 50 μg of ethinyl estradiol, and the progestin that is administered in combination with estrogen for a period of 21 or more consecutive days is administered in a daily amount equivalent to about 0.05 mg to about 0.5 mg of levonorgestrel.

18 . The method of claim 13 , wherein the estrogen without progestin that is administered for a period of 1 to 14 consecutive days is administered in a daily amount equivalent to about 5 μg to about 50 μg of ethinyl estradiol.

19 . The method of claim 13 , wherein the estrogen that is administered in combination with the progestin for a period of 21 or more consecutive days is administered by an oral tablet.

20 . The method of claim 13 , wherein the progestin that is administered in combination with the estrogen for a period of 21 or more consecutive days is administered by an oral tablet.

21 . The method of claim 13 , wherein the combination of progestin and estrogen that is administered for a period of 21 or more consecutive days is administered by an oral tablet.

22 . The method of claim 13 , wherein the hormone-free period is immediately followed by a combination of estrogen and progestin for a period of 21 or more consecutive days, immediately followed by administration of estrogen without progestin for a period of 1 to 14 consecutive days, and then immediately followed by a hormone-free period of 11 to 91 consecutive days.

23 . A method of treating estrogen deficiency in a female in need thereof, the method comprising administering to the female a combination of estrogen and progestin for a period of 21 or more consecutive days, immediately followed by a hormone-free period of 11 or more consecutive days.

24 . A method of treating estrogen deficiency in a female in need thereof, the method comprising administering to the female a combination of estrogen and progestin for a period of 21 or more consecutive days, immediately followed by administration of estrogen without progestin for a period of 1 to 14 consecutive days, and then immediately followed by a hormone-free period of 11 to 91 consecutive days.

25 . A method of restoring estrogen to a pre-menopausal level in a female in need thereof, the method comprising administering to the female a combination of estrogen and progestin for a period of 21 or more consecutive days, immediately followed by a hormone-free period of 11 or more consecutive days.

26 . A method of restoring estrogen to a pre-menopausal level in a female in need thereof, the method comprising administering to the female a combination of estrogen and progestin for a period of 21 or more consecutive days, immediately followed by administration of estrogen without progestin for a period of 1 to 14 consecutive days, and then immediately followed by a hormone-free period of more 11 to 91 consecutive days.

27 . A method of treating amenorrhea in a female in need thereof, the method comprising administering to the female a combination of estrogen and progestin for a period of 21 or more consecutive days, immediately followed by a hormone-free period of 11 or more consecutive days.

28 . A method of treating amenorrhea in a female in need thereof, the method comprising administering to the female a combination of estrogen and progestin for a period of 21 or more consecutive days, immediately followed by administration of estrogen without progestin for a period of 1 to 14 consecutive days, and then immediately followed by a hormone-free period of 11 to 91 consecutive days.

29 . A method of treating anovulation in a female in need thereof, the method comprising administering to the female a combination of estrogen and progestin for a period of 21 or more consecutive days, immediately followed by a hormone-free period of 11 or more consecutive days.

30 . A method of treating anovulation in a female in need thereof, the method comprising administering to the female a combination of estrogen and progestin for a period of 21 or more consecutive days, immediately followed by administration of estrogen without progestin for a period of 1 to 14 consecutive days, and then immediately followed by a hormone-free period of 11 to 91 consecutive days.

31 . A method of treating or preventing a disease, a disorder, or a symptom associated with deficient endogenous levels of estrogen in a female in need thereof, the method comprising administering to the female a combination of estrogen and progestin for a period of 21 or more consecutive days, immediately followed by a hormone-free period of 11 or more consecutive days.

32 . A method of treating or preventing a disease, a disorder, or a symptom associated with deficient endogenous levels of estrogen in a female in need thereof, the method comprising administering to the female a combination of estrogen and progestin for a period of 21 or more consecutive days, immediately followed by administration of estrogen without progestin for a period of 1 to 14 consecutive days, and then immediately followed by a hormone-free period of 11 to 91 consecutive days.

33 . A method of increasing fertility in a female in need thereof, the method comprising administering to the female a combination of estrogen and progestin for a period of 21 or more consecutive days, immediately followed by a hormone-free period of 11 or more consecutive days.

34 . A method of increasing fertility in a female in need thereof, the method comprising administering to the female a combination of estrogen and progestin for a period of 21 or more consecutive days, immediately followed by administration of estrogen without progestin for a period of 1 to 14 consecutive days, and then immediately followed by a hormone-free period of 11 to 91 consecutive days.

35 . A pharmaceutical kit comprising:

a) 21 or more daily doses of estrogen;

b) 21 or more daily doses of progestin;

c) 11 or more daily doses of a placebo pill; and

d) a label comprising a direction for administering the placebo pill after the estrogen and progestin.

36 . The pharmaceutical kit of claim 35 , wherein the daily doses of estrogen are in combination with the daily doses of progestin.

37 . The pharmaceutical kit of claim 36 , further comprising 1 to 14 daily doses of estrogen without progestin.

38 . The pharmaceutical kit of claim 35 , comprising 11 to 91 daily doses of a placebo pill.

39 . The pharmaceutical kit of claim 35 , comprising 21 to 119 daily doses of estrogen and 21 to 119 daily doses of progestin.

40 . The pharmaceutical kit of claim 35 , comprising 21 to 91 daily doses of estrogen and 21 to 91 daily doses of progestin.