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Claims for Patent: 6,214,815

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Claims for Patent: 6,214,815

Title: Triphasic oral contraceptive
Abstract:A method of contraception in which an estrogen and a progestogen are administered daily in a three phase sequence for 21 days is disclosed. In the first phase a combination of an estrogen and a progestogen in a low but contraceptively effective daily dosage corresponding in estrogenic activity to 23-28 .mu.g of 17.alpha.-ethinylestradiol and in progestogenic activity to 0.065-0.75 mg of norethindrone is administered for 5-8 days; followed by the administering of the same dosage of estrogen and a progestogen corresponding in progestogenic activity to 0.25-1.0 mg of norethindrone for 7-11 days; followed by the administering of the same dosage of estrogen and a progestogen corresponding in progestogenic activity to 0.35-2.0 mg of norethindrone for 3-7 days; followed by 4-8 days without administering either an estrogen or a progestogen.
Inventor(s): Shangold; Gary (Califon, NJ), Rubin; Arkady (Brooklyn, NY), Upmalis; David (Newtown, PA)
Assignee: Ortho-McNeil Pharmaceuticals, Inc. (Raritan, NJ)
Application Number:09/328,764
Patent Claims: 1. A method of contraception which comprises administering for 21 successive days to a female of childbearing age a combination of 17.alpha.-ethinylestradiol and norgestimate for the first 7 days in a daily dosage corresponding to 25 .mu.g of 17.alpha.-ethinylestradiol and 0.180 mg of norgestimate, for the succeeding 7 days a daily dosage equal to 25 .mu.g of 17.alpha.-ethinylestradiol aid 0.215 mg of norgestimate; and for the next 7 days a daily dosage equal to 25 .mu.g of 17.alpha.-ethinylestradiol and 0.250 mg of norgestimate; followed by 7 days without estrogen and progestogen administration.

2. A triphasic oral contraceptive unit having 21 separate dosage units, adapted for successive daily oral administration comprising: 5-8 dosage units containing, in admixture with a pharmaceutically acceptable carrier, a combination of an estrogen and a progestogen at contraceptively effective dosages corresponding in estrogenic activity to 25 .mu.g of 17.alpha.-ethinylestradiol and in progestogenic activity to 0.180 mg of norgestimate as a first phase; followed by 7-11 dosage units containing in admixture with a pharmaceutically acceptable carrier, a combination of an estrogen and a progestagen at a contraceptively effective dosage corresponding in estrogenic activity to 25 .mu.g of 17.alpha.-ethinylestradiol and in progestogenic activity to 0.215 mg of norgestimate as a second phase; followed by 3-7 dosage units containing in admixture with a pharmaceutically acceptable carrier, a combination of an estrogen at a contraceptively effective dosage corresponding in estrogenic activity to 25 .mu.g of 17.alpha.-ethinylestradiol and in progestogenic activity to 0.250 mg of norgestimate as a third phase; and optionally containing 4-8 additional dosage units free of estrogen and progestogen.

3. A method of contraception which comprises administering for 21 successive days to a female of childbearing age a combination of an estrogen and a progestogen in a contraceptively effective daily dosage in which there is a first phase of 5-8 days where the combination comprises a progestogen equivalent in effect to about 0.180 mg of norgestimate and an estrogen equivalent in effect to about 25 .mu.g of ethinyl estradiol; followed by a second phase of 7-11 days, where the combination comprises a progestogen equivalent in effect to about 0.215 mg of a norgestimate and an estrogen equivalent in effect to about 25 .mu.g of ethinyl estradiol; followed by a third phase of 3-7 days where the combination comprises a progestogen equivalent in effect to about 0.250 mg of norgestimate in combination with an estrogen equivalent in effect to about 25 .mu.g of ethinyl estradiol; and followed by 4-8 days which are free of hormone administration.

4. A triphasic oral contraceptive unit having 21 separate dosage units, adapted for successive daily oral administration comprising: 7 dosage units containing in admixture with a pharmaceutically acceptable carrier, 25 .mu.g of 17.alpha.-ethinylestradiol and 0.180 mg of norgestimate, 7 dosage units containing in admixture with a pharmaceutically acceptable carrier, 25 .mu.g of 17.alpha.-ethinylestradiol and 0.215 mg of norgestimate; and 7 dosage units containing in admixture with a pharmaceutically acceptable carrier, 25 .mu.g of 17.alpha.-ethinylestradiol and 0.250 mg of norgestimate; and optionally containing 7 additional dosage units free of estrogen and progestogen.
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