Composition for contraception

Abstract

A combination product for oral contraception is disclosed comprising an estrogen selected from 2.0 to 6.0 mg of 17β-estradiol and 0.020 mg of ethinylestradiol; and a gestagen selected from 0.25 to 0.30 mg of drospirenone and 0.1 to 0.2 mg of cyproterone acetate, followed by 5 or 4 pill-free or sugar pill days.

We claim: 
     
       1. A combination product for oral contraception, comprising
 (a) 23 or 24 dosage units, each containing an estrogen selected from
 >2.0 to 6.0 mg of 17β-estradiol and 
 0.020 mg of ethinylestradiol; 
   
       and a gestagen selected from
   0.25 to 0.30 mg of drospirenone and   0.1 to 0.2 mg of cyproterone acetate,   
 
       and
 b) 5 or 4, respectively, active ingredient-free placebo pills or other indications to show that the daily administration of the 23 or 24 dosage units respectively, is to be followed by 5 or 4, respectively pill-free or placebo pill days. 
 
     
     
       2. A combination preparation for oral contraception according to  claim 1 , wherein the estrogen is ethinylestradiol. 
     
     
       3. A combination preparation of  claim 2 , wherein the gestagen is cyproterone acetate. 
     
     
       4. A combination preparation of  claim 2 , wherein the gestagen is drospirenone. 
     
     
       5. A combination preparation according to  claim 1 , wherein the estrogen is present in a dose of 20 μg of ethinylestradiol or an equivalent dose of 17β-estradiol and the gestagen is present in a dose equivalent to 75 μg of gestadene. 
     
     
       6. A combination preparation according to  claim 1 , which comprises 23 dosage units and 5 placebo pills or other indications to show that no dosage unit or a placebo pill is administered during the last 5 days of the menstrual cycle. 
     
     
       7. A combination preparation according to  claim 1 , which comprises 23 dosage units, each containing 20 μg of ethinylestradiol and a dose of cyproterone acetate or drospirenone equivalent to 75 μg of gestodene and 5 placebo pills or other indications to show that no dosage unit or a placebo pill is administered during the last 5 days of the menstrual cycle. 
     
     
       8. A combination preparation of  claim 1 , wherein the estrogen is 17β-estradiol. 
     
     
       9. A combination preparation of  claim 8 , wherein the gestagen is cyproterone acetate. 
     
     
       10. A combination preparation of  claim 8 , wherein the gestagen is drospirenone. 
     
     
       11. A method of inducing contraception in a female of reproductive age who has not yet reached premenopause, comprising administering to said female a monophasic composition that effectively lessens premenstrual syndrome, comprising 0.015 to 0.020 mg of ethynylestradiol and 1-3 mg of drospirenone, wherein the composition is administered for 23 or 24 days, beginning on day one of the menstrual cycle, followed by 5 or 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle. 
     
     
       12. A method of claim 11 wherein the amount of ethynylestradiol is 0.020 mg and the amount of drospirenone is 3 mg. 
     
     
       13. A method of claim 12 wherein the composition is administered for 24 days, beginning on day one of the menstrual cycle, followed by 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle. 
     
     
       14. A method of inducing contraception in a female of reproductive age who has not yet reached premenopause, comprising administering to said female a monophasic composition that effectively lessens breast tenderness, comprising 0.015 to 0.020 mg of ethynylestradiol and 1-3 mg of drospirenone, wherein the composition effectively lessens breast tenderness, and is administered for 23 or 24 days, beginning on day one of the menstrual cycle, followed by 5 or 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle. 
     
     
       15. A method of claim 14 wherein the amount of ethynylestradiol is 0.020 mg and the amount of drospirenone is 3 mg. 
     
     
       16. A method of claim 15 wherein the composition is administered for 24 days, beginning on day one of the menstrual cycle, followed by 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle. 
     
     
       17. A method of claim 11 wherein the composition effectively lessens breast tenderness. 
     
     
       18. A method of claim 17 wherein the amount of ethynylestradiol is 0.020 mg and the amount of drospirenone is 3 mg. 
     
     
       19. A method of claim 18 wherein the composition is administered for 24 days, beginning on day one of the menstrual cycle, followed by 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle. 
     
     
       20. A method of inducing contraception in a female of reproductive age suffering from premenstrual syndrome who has not yet reached premenopause, comprising administering to said female a monophasic composition comprising 0.015 to 0.020 mg of ethynylestradiol and 1-3 mg of drospirenone, wherein the composition is administered for 23 or 24 days, beginning on day one of the menstrual cycle, followed by 5 or 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle. 
     
     
       21. A method of claim 20 wherein the amount of ethynylestradiol is 0.020 mg and the amount of drospirenone is 3 mg. 
     
     
       22. A method of claim 21 wherein the composition is administered for 24 days, beginning on day one of the menstrual cycle, followed by 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle. 
     
     
       23. A method of inducing contraception in a female of reproductive age suffering from breast tenderness who has not yet reached premenopause, comprising administering to said female a monophasic composition comprising 0.015 to 0.020 mg of ethynylestradiol and 1-3 mg of drospirenone, wherein the composition is administered for 23 or 24 days, beginning on day one of the menstrual cycle, followed by 5 or 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle. 
     
     
       24. A method of claim 23 wherein the amount of ethynylestradiol is 0.020 mg and the amount of drospirenone is 3 mg. 
     
     
       25. A method of claim 24 wherein the composition is administered for 24 days, beginning on day one of the menstrual cycle, followed by 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle. 
     
     
       26. A method of claim 20 wherein the female of reproductive age suffers from breast tenderness. 
     
     
       27. A method of claim 26 wherein the amount of ethynylestradiol is 0.020 mg and the amount of drospirenone is 3 mg. 
     
     
       28. A method of claim 27 wherein the composition is administered for 24 days, beginning on day one of the menstrual cycle, followed by 4 pill-free or sugar pill days, during a total of 28 days in the administration cycle.