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Claims for Patent: 5,010,070

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Claims for Patent: 5,010,070

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:07/526,934
Patent Claims: 1. A multiphase combination and contraceptive kit comprising a package containing daily dosages of:

(1) a Phase I composition containing about 0.5-1.5 mg norethindrone acetate and about 10-50 mcg ethinyl estradiol;

( 2) a Phase II composition containing about 0.5-1.5 mg norethindrone acetate and about 10-50 mcg ethinyl estradiol; and

(3) a Phase III composition containing about 0.5-1.5 mg norethindrone acetate and about 10-50 mcg ethinyl estradiol, wherein the amount of ethinyl estradiol is increased stepwise over the three compositions.

2. The kit of claim 1 which additionally comprises a Phase IV composition containing ferrous fumarate.

3. The kit of claim 2 wherein the composition for Phase IV contains about 75 mg ferrous fumarate.

4. A multiphase combination and contraceptive kit comprising a package containing:

(1) about 4 to 7 dosages of a Phase I composition containing about 0.5-1.5 mg norethindrone acetate and about 10-30 mcg ethinyl estradiol;

(2) about 5 to 8 dosages of a Phase II composition containing about 0.5-1.5 mg norethindrone acetate and about 20-40 mcg ethinyl estradiol, and

(3) about 7 to 12 dosages of a Phase III composition containing about 0.5-1.5 mg norethindrone acetate and about 30-50 mcg ethinyl estradiol, wherein the amount of ethinyl estradiol is increased stepwise over the three compositions.

5. The kit of claim 4 which additionally comprises about 9 dosages of a Phase IV composition containing ferrous fumarate.

6. The kit of claim 5 wherein the composition for Phase IV contains about 75 mg ferrous fumarate.

7. The kit of claim 4 wherein the Phase I composition contains about 1.0 mg norethindrone acetate and about 20 mcg ethinyl estradiol; the Phase II composition contains about 1.0 mg norethindrone acetate and about 30 mcg ethinyl estradiol; and the Phase III composition contains about 1.0 mg norethindrone acetate and about 40 mcg ethinyl estradiol.

8. The kit of claim 7 containing about 5 dosages of the Phase I composition, about 7 dosages of the Phase II composition, and about 9 dosages of the Phase III composition.

9. The kit of claim 4 wherein the Phase I composition contains about 1.0 mg norethindrone acetate and about 20 mcg ethinyl estradiol; Phase II composition contains about 1.5 mg norethindrone acetate and about 30 mcg ethinyl estradiol; and the Phase III composition contains about 1.0 mg norethindrone acetate and about 50 mcg ethinyl estradiol.

10. The kit of claim 9 containing about 5 dosages of the Phase I composition, about 7 dosages of the Phase II composition, and about 9 dosages of the Phase III composition.

11. The kit of claim 4 wherein the Phase I composition contains about 1.0 mg norethindrone acetate and about 20 mcg ethinyl estradiol; the Phase II composition contains about 1.0 mg norethindrone acetate and about 30 mcg ethinyl estradiol; and the Phase III composition contains about 1.0 mg norethindrone acetate and about 35 mcg ethinyl estradiol.

12. The kit of claim 11 containing about 5 dosages of the Phase I composition, about 7 dosages of the Phase II composition, and about 9 dosages of the Phase III composition.
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