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Claims for Patent: 4,962,098

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Claims for Patent: 4,962,098

Title: Graduated estrogen contraceptive
Abstract:Contraceptive methods and delivery systems involving few undesirable side effects during administration are based on novel triphasic estrogen/progestogen combinations, wherein the amount of estrogen is increased stepwise over the three phases.
Inventor(s): Boissonneault; Roger M. (Long Valley, NJ)
Assignee: Warner-Lambert Company (Morris Plains, NJ)
Application Number:07/340,974
Patent Claims: 1. A method of contraception comprising the steps of sequentially-administering to a female of child bearing age:

(1) for about 4 to about 7 days, a composition I containing about 0.5-1.5 mg norethindrone acetate and about 10-50 mcg ethinyl estradiol,

(2) for about 5 to about 8 days, a composition II containing about 0.5-1.5 mg norethindrone acetate and about 10-50 mcg ethinyl estradiol, and

(3) for about 7 to about 12 days, a composition III containing 0.5-1.5 mg norethindrone acetate and about 10-50 mcg ethinyl estradiol, wherein the amount of ethinyl estradiol is increased stepwise by the amount of at least 5 mcg in each step.

2. The method of claim 1 which comprises the additional step of administering, for about 7 days, a composition IV containing ferrous fumarate.

3. The method of claim 1 wherein composition I contains about 0.5-1.5 mg norethindrone acetate and about 10-30 mcg ethinyl estradiol; composition II contains 0.5-1.5 mg norethindrone acetate and 20-40 mcg ethinyl estradiol; and composition III contains 0.5-1.5 mg norethindrone acetate and about 30-50 mcg ethinyl estradiol.

4. The method of claim 1 wherein composition I is administered for about 5 days and contains about 1.0 mg norethindrone acetate and about 20 mcg ethinyl estradiol; composition II is administered for about 7 days and contains about 1.0 mg norethindrone acetate and about 30 mcg ethinyl estradiol; and composition III is administered for about 9 days and contains about 1.0 mg norethindrone acetate and about 40 mcg ethinyl estradiol.

5. The method of claim 4 wherein the compositions are administered in combination with a suitable carrier.

6. The method of claim 1 wherein composition I is administered for about 5 days and contains about 1.0 mg norethindrone acetate and about 20 mcg ethinyl estradiol; composition II is administered for about 7 days and contains about 1.5 mg norethindrone acetate and about 30 mcg ethinyl estradiol; and composition III is adminstered for about 9 days and contains about 1.0 mg norethindrone acetate and about 50 mcg ethinyl estradiol.

7. The method of claim 6 wherein the compositions are administered in combination with a suitable carrier.

8. The method of claim 1 wherein composition I is administered for about 5 days and contains about 1.0 mg norethindrone acetate and about 20 mcg ethinyl estradiol; composition II is administered for about 7 days and contains about 1.0 mg norethindrone acetate and about 30 mcg ethinyl estradiol; and composition III is administered for about 9 days and contains about 1.0 mg norethindrone acetate and about 35 mcg ethinyl estradiol.

9. The method of claim 8 wherein the compositions are administered in combination with a suitable carrier.
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