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Claims for Patent: 4,544,554

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Claims for Patent: 4,544,554

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 0.02-0.05 mg 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 6-8 days without administering either an estrogen or a progestogen.
Inventor(s): Pasquale; Samuel A. (Basking Ridge, NJ)
Assignee: Ortho Pharmaceutical Corporation (Raritan, NJ)
Application Number:06/607,038
Patent Claims: 1. 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 low but contraceptively effective daily dosage corresponding in estrogenic activity to 0.02-0.05 mg of 17.alpha.-ethinylestradiol and in progestogenic activity to 0.065-0.75 mg of norethindrone for 5-8 days; for the next 7-11 days an estrogen daily dosage equal to 0.02-0.05 mg of 17.alpha.-ethinylestradiol and in progestogenic activity to 0.250-1.0 mg of norethindrone; and for the next 3-7 days an estrogen daily dosage equal to 0.02-0.05 mg of 17.alpha.-ethinylestradiol and in progestogenic activity 0.35-2.0 mg of norethindrone; followed by 6-8 days without estrogen and progestogen administration, provided that the estrogen daily dosage is the same for each period.

2. The method of claim 1 wherein the estrogen and progestogen are administered orally and the period specified in each phase is seven days.

3. The method of claim 2 wherein the estrogen and progestogen are administered in admixture.

4. The method of claim 1 wherein the progestogen is selected from D-norgestrel, norethindrone, progesterone and D-17.beta.-acetoxy-13.beta.-ethyl-17.alpha.-ethinyl-gon-4-en-3-one oxime.

5. The method of claim 3 wherein the estrogen is selected from 17.alpha.-ethinylestradiol, estrone, estradiol and estriol.

6. The method of claim 3 wherein the estrogen is 17.alpha.-ethinylestradiol and the progestogen is norethindrone.

7. The method of claim 1 wherein the estrogen is 17.alpha.-ethinylestradiol and the progestogen is D-17.beta.-acetoxy-13.beta.-ethyl-17.alpha.-ethinyl-gon-4-en-3-one oxime.

8. The method of claim 6 wherein the estrogen daily dosage is 0.035 mg for each 7 day period and the progestogen daily dosage is 0.5 mg for the first 7 days, 0.75 mg for the second 7 days and 1.0 mg for the third 7 days.

9. The contraception method of claim 1 which comprises administering for 21 successive days to a female of childbearing age a combination of 17.alpha.-ethinylestradiol and norethindrone in a contraceptively effective daily dosage corresponding to 0.035 mg of 17.alpha.-ethinylestradiol and 0.50 mg of norethindrone for 7 days; for the next 7 days a daily dosage equal to 0.035 mg of 17.alpha.-ethinylestradiol and 0.75 mg of norethindrone; and for the next 7 days a daily dosage equal to 0.035 mg of 17.alpha.-ethinylestradiol and 1.0 mg of norethindrone; followed by 7 days without estrogen and progestogen administration.

10. The contraception method of claim 1 which comprises administering for 21 successive days to a female of childbearing age a combination of 17.alpha.-ethinylestradiol and norgestimate in a contraceptively effective daily dosage corresponding to 0.035 mg of 17.alpha.-ethinylestradiol and 0.180 mg of norgestimate for 7 days; for the next 7 days a daily dosage equal to 0.035 mg of 17.alpha.-ethinylestradiol and 0.215 mg of norgestimate; and for the next 7 days a daily dosage equal to 0.035 mg of 17.alpha.-ethinylestradiol and 0.250 mg of norgestimate; followed by 7 days without estrogen and progestogen administration.
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