Management of breakthrough bleeding in extended hormonal contraceptive regimens
View Patent ↗The present invention relates to a flexible extended use regimen for a hormonal contraceptive useful to manage bleeding problems associated with fixed extended use of hormonal contraceptives and to a pharmaceutical package containing the respective hormonal contraceptive.
1. A method for oral contraception in a woman comprising the following monophasic, extended, cyclic regimen:
(1) administering to said woman an oral contraceptive, which comprises 20 μg of ethinyl estradiol and 3 mg of drospirenone, daily for a first period of 24 days, and thereafter administering said oral contraceptive daily for a second period of a maximum of 96 days during which (a) said woman initiates a break of 3-6 days in which the oral contraceptive is not administered, or (b) if no such break is initiated within said maximum of 96 days, said woman initiates a break period of 3-6 days at the end of the 96 day period, and
(2) after said break period, administering said oral contraceptive with an administration/break pattern in accordance with (1) above,
wherein a second period is at least one day long.
2. A method according to claim 1 wherein said break is 4 days long.
3. A method according to claim 2 wherein in an administration/break pattern (1) a second period of up to 96 days long in which said oral contraceptive is administered is longer than said first 24 day period.
4. A method according to claim 2 wherein the woman stops administering said oral contraceptive in a second period of up to 96 days long upon the occurrence of breakthrough bleeding.
5. A method according to claim 2 wherein the woman does not stop administering said oral contraceptive in a second period of up to 96 days long.
6. A method of claim 2 wherein in an administration/break pattern (1) a second period of up to 96 days long in which said oral contraceptive is administered is at least as long as the first 24 day period.
7. A method according to claim 2 wherein the woman stops administering said oral contraceptive within said period of up to 96 days long.
8. A method according to claim 2 wherein the woman stops administering said oral contraceptive within said period of up to 96 days long in the absence of bleeding problems.
9. A method for management of unacceptable bleeding during oral contraception in a woman comprising the following monophasic, extended, cyclic regimen:
(1) administering to said woman an oral contraceptive, which comprises 20 μg of ethinyl estradiol and 3 mg of drospirenone, daily for a first period of 24 days, and thereafter administering said oral contraceptive daily for a second period of a maximum of 96 days during which (a) said woman, upon occurrence of bleeding initiates a break of 3-6 days in which the oral contraceptive is not administered, or (b) if no such break is initiated within said maximum of 96 days, said woman initiates a break period of 3-6 days at the end of the 96 day period, and
(2) after said break period, administering said oral contraceptive with an administration/break pattern in accordance with (1) above,
wherein a second period is at least one day long.
10. A method according to claim 9 wherein said break is 4 days long.
11. A method according to claim 10 wherein in an administration/break pattern (1) a second period of up to 96 days long in which said oral contraceptive is administered is longer than said first 24 day period.
12. A method according to claim 10 wherein said bleeding is breakthrough bleeding.
13. A method according to claim 10 wherein the woman does not stop administering said oral contraceptive in a second period of up to 96 days long.
14. A method according to claim 10 wherein in an administration/break pattern (1) a second period of up to 96 days long in which said oral contraceptive is administered is at least as long as the first 24 day period.