Claims for Patent: RE35724

Summary for Patent: RE35724

Title:	Contraception system and method
Abstract:	A method of contraception is disclosed which comprises a two-stage protocol. In the first stage, an estrogenic compound in a first composition is administered daily as the sole contraceptively active substance to a human female from about Day 2 to about Day 7 of her menstrual cycle, where Day 1 is the first day of menses. The second stage of the protocol occurs immediately thereafter during which at least one follow-up composition containing a progestin is administered daily to the same human female. The follow-up composition can contain a progestin as the sole contraceptively active ingredient, or can contain a combination of an estrogenic compound with a progestin in different weight ratios. A drug delivery system containing daily dosage units is also described.
Inventor(s):	Pasquale; Samuel A. (Basking Ridge, NJ)
Assignee:	Bio-Technology General Corp. (Iselin, NJ)
Application Number:	08/369,309
Patent Claims:	1. A method of contraception .Iadd.by suppressing recruitment of the dominant follicle .Iaddend.comprising: (a) administering .Iadd.orally .Iaddend.to a human female of child-bearing age, daily from .[.about Day 2 to about.]. .Iadd.Day 3 or Day 4 through .Iaddend.Day 7 of her menstrual cycle, wherein Day 1 is the first day of menses, a first composition containing as sole contraceptively active ingredient an estrogenic compound at a daily dosage equivalent in estrogenic activity in the range of about 0.01 to about 0.04 milligrams of 17-alpha-ethinyl estradiol; and thereafter (b) administering .Iadd.orally .Iaddend.to said female, daily through Day 28 of her menstrual cycle, at least one follow-up composition containing a contraceptively effective daily dosage of a progestin. 2. The method of contraception according to claim 1, wherein said follow-up composition contains a progestin as sole contraceptively active ingredient. 3. The method of contraception according to claim 1, wherein said follow-up composition comprises contraceptively effective amounts of an estrogenic compound and a progestin. 4. The method of contraception according to claim 1 wherein said estrogenic compound is ethinyl estradiol. 5. The method of contraception according to claim 1 wherein said estrogenic compound is mestranol. 6. The method of contraception according to claim 1 wherein said estrogenic compound is 17-beta-estradiol. 7. The method of contraception according to claim 1 wherein said follow-up composition contains norethindrone at a daily dosage in the range of about 0.5 mg to about 1.0 mg. 8. The method of contraception according to claim 1, wherein said progestin is D-norgestrel. 9. The method of contraception according to claim 1, wherein said progestin is D-17-beta-acetoxy-13-beta-ethyl-17-alpha-ethinyl-gon-4-en-3-one oxime. 10. The method of contraception according to claim 1, wherein said progestin is a 19-nor-17-hydroxy progesterone ester. 11. The method of contraception according to claim 1 wherein said estrogenic compound is ethinyl estradiol and said progestin is norethindrone. 12. The method of contraception according to claim 1 wherein said estrogenic compound is mestranol and said progestin is D-norgestrel. 13. The method of contraception according to claim 1 wherein plural follow-up compositions are administered in sequence, wherein the daily dosage of the estrogenic compound is substantially the same in all administered follow-up compositions, and wherein the daily dosage of progestin is greater in each successive follow-up composition. 14. The method of contraception according to claim 13 wherein said estrogenic compound is ethinyl estradiol and said progestin is norethindrone. 15. The method of contraception according to claim 14 wherein said daily dosage of ethinyl estradiol is about 0.035 mg. 16. The method of contraception according to claim 1 wherein plural follow-up compositions are administered in sequence, wherein the daily dosage of the estrogenic compound is substantially the same in all administered follow-up compositions; and wherein the daily dosage or progestin in successive follow-up compositions first increases to a value greater than the daily progestin dosage first administered and then decreases to the same value as the daily progestin dosage first administered. 17. The method of contraception according to claim 16 wherein said daily dosage of ethinyl estradiol is 0.035 mg. 18. A drug delivery system constituted by at least 24 separate daily dosage units, adapted for oral administration and comprising: at least four .Iadd.but not more than five .Iaddend.initial dosage units each containing as the sole contraceptively active ingredient the same contraceptively effective daily dosage of an estrogenic compound; followed by twenty-one follow-up dosage units each containing a contraceptively effective daily dosage of a progestin. 19. The drug delivery system according to claim 18, wherein aid twenty-one follow-up dosage units each contain substantially the same daily dosage of a progestin. 20. The drug delivery system according to claim 18, wherein said twenty-one follow-up dosage units each contain substantially the same daily dosage of an estrogenic compound and a progestin. 21. The drug delivery system according to claim 18 wherein said twenty-one follow-up dosage units comprise a first group of 10 dosage units that each contain a first contraceptively effective daily dosage of an estrogenic compound and a progestin, and a second group of 11 dosage units that each contain a follow-up contraceptively effective daily dosage of a progestin and an estrogenic compound. 22. The drug delivery system according to claim 18 wherein said follow-up dosage units comprise three consecutive groups of about seven dosage units each, and wherein each of said groups individually comprises contraceptively effective daily dosage units of an estrogenic compound and a progestin present in substantially the same weight ratio, with the proviso that the weight ratios of said estrogenic compound to said progestin are different for the respective dosage units that constitute consecutively administered groups. 23. The drug delivery system according to claim 22 wherein the weight ratio of said estrogenic compound to said progestin is substantially the same in the first and the third consecutive groups of dosage units. 24. The drug delivery system according to claim 18 wherein said estrogenic compound present in said initial dosage units is ethinyl estradiol. 25. The group delivery system according to claim 18 wherein said estrogenic compound present in said initial dosage units is mestranol. 26. The drug delivery system according to claim 18 wherein said estrogenic compound present in said initial dosage units is 17-beta-estradiol. 27. The drug delivery system according to claim 18, wherein said progestin is norethindrone. 28. The drug delivery system according to claim 18 wherein said progestin is D-norgestrel.