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Claims for Patent: 5,552,394

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Claims for Patent: 5,552,394

Title: Low dose oral contraceptives with less breakthrough bleeding and sustained efficacy
Abstract:A method of female contraception which is characterized by a reduced incidence of breakthrough bleeding after the first cycle involves monophasicly administering a combination of estrogen and progestin for 23-25 consecutive days of a 28 day cycle in which the daily amounts of estrogen and progestin are equivalent to about 5-35 mcg of ethinyl estradiol and about 0.025 to 10 mg of norethindrone acetate, respectively and in which the weight ratio of estrogen to progestin is at least 1:45 calculated as ethinyl estradiol to norethindrone acetate.
Inventor(s): Hodgen; Gary D. (Norfolk, VA)
Assignee: The Medical College of Hampton Roads (Norfolk, VA)
Application Number:08/279,300
Patent Claims: 1. A method of female contraception which is characterized by a reduced incidence of breakthrough bleeding after the first cycle which comprises monophasicly administering a combination of estrogen and progestin for 23-25 consecutive days of a 28 day cycle in which the daily amounts of estrogen and progestin are equivalent to about 1-35 mcg of ethinyl estradiol and about 0.025 to 10 mg of norethindrone acetate, respectively, and in which the weight ratio of estrogen to progestin is at least 1:45 calculated as ethinyl estradiol to norethindrone acetate.

2. The method of claim 1 in which the daily amount of progestin is equivalent to 0.5-0.75 mg of norethindrone acetate.

3. The method of claim 2 in which the weight ratio is at least 1:50.

4. The method of claim 3 in which the combination is administered for 24 days of the 28 day cycle.

5. The method of claim 4 in which the estrogen is ethinyl estradiol.

6. The method of claim 5 in which the progestin is norethindrone acetate.

7. The method of claim 1 in which the daily amount of progestin is equivalent to 0.5-1.5 mg of norethindrone acetate.

8. The method of claim 1 in which the weight ratio is at least 1:50.

9. The method of claim 1 in which the combination is administered for 24 days of the 28 day cycle.

10. The method of claim 1 in which the estrogen is ethinyl estradiol.

11. The method of claim 1 in which the progestin is norethindrone acetate.

12. The method of claim 1 in which the daily amount of estrogen is up to 30 mcg of ethinyl estradiol.
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