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Claims for Patent: RE39861

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Claims for Patent: RE39861

Title:Methods of extended use oral contraception
Abstract:A method of female contraception involves administering a combination of estrogen and progestin for 60-110 consecutive days 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. The advantages include less menstrual bleeding, less patient anemia, less total exposure to medication, higher compliance rates and more lifestyle convenience for patients.
Inventor(s): Hodgen; Gary D. (Virginia Beach, VA)
Assignee: Duramed Pharmaceuticals, Inc. (Pomona, NY)
Application Number:10/893,795
Patent Claims: 1. A method of .Iadd.extended .Iaddend.female contraception .Iadd.that reduces the number of menstrual periods per year, .Iaddend.which comprises .Iadd.orally .Iaddend.monophasicly administering to a pre-menopausal female a combination of estrogen and progestin for .[.60-110.]. .Iadd.84 .Iaddend.consecutive days in which the daily amounts of estrogen and progestin are equivalent to about .[.5-35.]. .Iadd.30 .Iaddend.mcg of ethinyl estradiol and about .[.0.025 to 10.]. .Iadd.0.25-1.5 .Iaddend.mg of norethindrone acetate, respectively, .[.following.]. .Iadd.followed .Iaddend.by .[.non-administration.]. .Iadd.administration of a placebo .Iaddend.for a period of .[.3-10.]. .Iadd.5-8 .Iaddend.days.Iadd., wherein the combination of estrogen and progestin and the placebo are packaged together in a kit, and wherein the method of female contraception reduces the number of menstrual periods per year to four when the method is practiced for at least one year.Iaddend..

.[.2. The method of claim 1 in which the daily amount of estrogen is equivalent to about 10 to 20 mcg of ethinyl estradiol..].

.[.3. The method of claim 2 in which the daily amount of progestin is equivalent to 0.25-1.5 mg of norethindrone acetate..].

.[.4. The method of claim 3 in which the combination is administered for at least 80 consecutive days..].

.[.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 0.25-1.5 mg of norethindrone acetate..].

.[.8. The method of claim 1 in which the combination is administered for at least 80 consecutive days..].

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

.[.10. The method of claim 1 in which the progestin is norethindrone acetate..].

.[.11. The method of claim 1 in which the daily amount of estrogen is up to 30 mcg of ethinyl estadiol..].

.Iadd.12. The method of claim 9 in which the progestin is levonorgestrel..Iaddend.
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