Extended estrogen dosing contraceptive regimen

Abstract

A contraceptive kit comprising a package containing daily dosages of: (a) a first composition containing a progestin in an amount equivalent to about 0.3 to about 1.5 mg norethindrone acetate and an estrogen in an amount equivalent to about 5 to about 20 mcg of ethinyl estradiol for about 22 to about 26 days; (b) a second composition containing an estrogen in an amount equivalent to about 5 to about 20 mcg of ethinyl estradiol for about 2 to about 3 days and an optional third composition that is a placebo provided that (i) if estrogen administration is continuous then the first composition is administered for 25 to 26 days, the second composition is administered for 2 to 3 days and no third composition is administered and (ii) if estrogen administration is not continuous then the first composition is administered for 22 to 24 days, the second composition is administered for 2 to 3 days and the third composition is administered for 1 to 4 days. The total cycle length is 28 days, with the first composition administered on day 1 of the menstrual cycle, defined as the first day of menstrual bleeding, or on the first Sunday after the first day of the menstrual cycle.

1 . A contraceptive kit comprising a package containing daily dosages of:
 (a) a first composition containing a progestin in an amount equivalent to about 0.3 to about 1.5 mg norethindrone acetate and an estrogen in an amount equivalent to about 5 to about 20 mcg of ethinyl estradiol;   (b) a second composition containing an estrogen in an amount equivalent to about 5 to about 20 mcg of ethinyl estradiol and substantially free of a progestin; an   (c) an optional third composition that is a placebo,   wherein the package contains 22 to 26 daily dosages of the first composition, 2 to 3 daily dosages of the second composition, optionally 1 to 4 daily dosages of the third composition, and a total amount of daily dosages of the first composition, second composition and optional third composition, when present, is 28 and further provided that (i) when the kit contains no third composition then the package contains 25 to 26 monophasic daily dosages of the first composition and 2 to 3 daily dosages of the second composition and (ii) when the kit contains 1 to 4 daily dosages of the third composition then the package contains 22 to 24 daily dosages of the first composition and 2 to 3 daily dosages of the second composition.   
     
     
         2 . The kit according to  claim 1 , wherein the package contains 25 to 26 daily dosages of the first composition and 2 to 3 daily dosages of the second composition. 
     
     
         3 . The kit according to  claim 1 , wherein the package contains 22 to 24 daily dosages of the first composition, 2 to 3 daily dosages of the second composition and 1 to 4 daily dosages of the third composition. 
     
     
         4 . The kit according to  claim 1 , wherein the progestin is selected from the group consisting of norethindrone acetate, drospirenone, trimegestone, norethindrone, levonorgestrel, desogestrel, 3-ketodesogestrel, gestodene, demogestone, dydrogesterone, medrogestone, medroxy progesterone, esters and mixtures thereof. 
     
     
         5 . The kit according to  claim 1 , wherein the estrogen is selected from the group consisting of ethinyl estradiol, 17-β-estradiol, conjugated estrogens, mestranol, estrone, and esters, prodrugs and salts thereof. 
     
     
         6 . The kit according to any one of  claims 2  and  3 , wherein the progestin in the first composition is norethindrone acetate. 
     
     
         7 . The kit according to  claim 6 , wherein the amount of norethindrone acetate in the first composition is about 1 mg. 
     
     
         8 . The kit according to any one of  claims 2  and  3 , wherein the estrogen in the first and second composition is ethinyl estradiol. 
     
     
         9 . The kit according to  claim 8 , wherein the amount of ethinyl estradiol in the first and second composition is about 15 mcg. 
     
     
         10 . The kit according to any one of  claims 2  and  3 , wherein (i) the first composition contains about 1.0 mg of norethindrone acetate and about 15 mcg of ethinyl estradiol, and (ii) the second composition contains about 15 mcg of ethinyl estradiol. 
     
     
         11 . The kit according to  claim 1 , wherein the placebo contains about 75 mg of ferrous fumarate.