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Claims for Patent: 4,390,531

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Claims for Patent: 4,390,531

Title: Method of contraception using peak progestogen dosage
Abstract:A method of contraception and a pharmaceutical package for effecting the method are disclosed. The method comprises a three phase sequence of estrogen/progestogen administration which is a daily sequence of unit dosages over a repeating cycle, which dosage sequence comprises, for one cycle: (a) administering, as phase one, about 20-40 .mu.g of ethinyl estradiol, (or of other estrogen in an amount sufficient to result in an equivalent effect) and about 0.3-0.8 mg of norethindrone (or of other progestogen in an amount sufficient to result in an equivalent effect) each day for 5-8 days, followed by; (b) administering, as phase two, the same dosage of estrogen and twice the dosage of progestogen each day as was administered each day in phase one, for 7-11 days, followed by; (c) administering, as phase three, the same dosage of estrogen and the same dosage of progestogen each day as was administered each day in phase one, for 3-7 days, followed by; (d) administering, as phase four, no therapeutically active dosage, i.e. either no treatment or a placebo each day for 6-8 days, with the proviso that the total number of days in phases one through three is 21.
Inventor(s): Edgren; Richard A. (Woodside, CA)
Assignee: Syntex Pharmaceuticals International Ltd. (Hamilton, BM)
Application Number:06/291,533
Patent Claims: 1. A method of contraception in the female human, which method comprises administering to a subject in need of, or desiring, such an effect, a daily sequence of unit dosages over a repeating cycle, which dosage sequence comprises, for one cycle:

(a) administering, as phase one, for a period of 5-8 days, daily dosages of a combination of an estrogen and a progestogen, wherein the amounts of estrogen and progestogen correspond in estrogenic activity to about 20-40 .mu.g of ethinyl estradiol, and in progestogenic activity to about 0.3-0.8 mg of norethindrone, followed by:

(b) administering, as phase two, for a period of 7-11 days, the same dosage of estrogen and twice the dosage of progestogen each day as was administered in phase 1, followed by:

(c) administering, as phase three, for a period of 3-7 days, the same dosage of estrogen and the same dosage of progestogen each day as was administered each day in phase one, followed by;

(d) administering, as phase four, for a period of 6-8 days, no therapeutically active dosage, i.e. either no treatment or a placebo each day,

with the proviso that the total number of days in phases one through three is 21.

2. A method of claim 1 wherein,

the period specified in (a) is seven days;

the period specified in (b) is seven days;

the period specified in (c) is seven days;

the period specified in (d) is seven days.

3. A method of claim 1 wherein,

the period specified in (a) is seven days;

the period specified in (b) is nine days;

the period specified in (c) is five days;

the period specified in (d) is seven days.

4. The method of claim 1 wherein, the dosages per day in (a) of estrogen and progestogen correspond in estrogenic activity to about 35 .mu.g of ethiny estradiol and in progestogenic activity to about 0.50 mg of norethindrone.

5. The method of claim 2 wherein, the dosages per day in (a) of estrogen and progestogen correspond in estrogenic activity to about 35 .mu.g of ethinyl estradiol and in progestogenic activity to about 0.50 mg of norethindrone.

6. The method of claim 3 wherein, the dosages per day in (a) of estrogen and progestogen correspond in estrogenic activity to about 35 .mu.g of ethiny estradiol and in progestogenic activity to about 0.50 mg of norethindrone.

7. The method of claim 1 wherein the estrogen is ethinyl estradiol.

8. The method of claim 1 wherein the progestogen is norethindrone.

9. The method of claim 1 wherein the estrogen is ethinyl estradiol, and the progestogen is norethindrone.
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