IP Library Granted Patent US 7,320,969
Granted Patent B2
US 7,320,969 · App. 10/309,313 · Granted Jan 22, 2008

Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology

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Quick Facts
Patent No.
US 7,320,969
App. No.
10/309,313
Granted
Jan 22, 2008
Kind
B2
Abstract

This invention relates to a method of preventing pregnancy and treating PMS including PMDD. More particularly, the invention relates to a method, which involves administering one of several combination oral contraceptive regimens in combination with an antidepressant and a kit containing the same.

Claims (31)

1. A method of contraception in a female in need thereof, the method comprising administering to the female a dosage comprising a combination of estrogen and progestin for a period of 81 to 89 consecutive days, followed by administration of a dosage consisting essentially of estrogen for a period of 2 to 8 consecutive days,

wherein the estrogen that is administered in combination with progestin for the period of 81 to 89 consecutive days is administered in a daily amount equivalent to about 10 μg to about 50 μg of ethinyl estradiol,

the estrogen that is administered for the period of 2 to 8 consecutive days is administered in a daily amount equivalent to about 5 μg to about 10 μg of ethinyl estradiol, and

the progestin that is administered for the period of 81 to 89 consecutive days is administered in a daily amount of about 150 μg of levonorgestrel.

2. The method of claim 1 , wherein the estrogen that is administered for the period of 81 to 89 consecutive days is administered in a daily amount equivalent to about 10 μg to about 30 μg of ethinyl estradiol.

3. The method of claim 1 , wherein the estrogen that is administered for the period of 81 to 89 consecutive days is administered in a daily amount equivalent to about 30 μg of ethinyl estradiol.

4. The method of claim 1 , wherein the estrogen that is administered for the period of 2 to 8 consecutive days is administered in a daily amount equivalent to about 10 μg of ethinyl estradiol.

5. The method of claim 1 , wherein the dosage comprising the combination of estrogen and progestin is administered for at least 84 consecutive days.

6. The method of claim 1 , wherein the dosage consisting essentially of estrogen is administered for a period of 5 to 8 consecutive days.

7. The method of claim 6 , wherein the dosage consisting essentially of estrogen is administered for at least 7 consecutive days.

8. The method of claim 1 , wherein the dosage comprising the combination of estrogen and progestin is administered for 84 consecutive days, and the dosage consisting essentially of estrogen is administered for 7 consecutive days.

9. The method of claim 1 , wherein the estrogen is ethinyl estradiol.

10. The method of claim 1 , wherein an antidepressant is administered (i) in combination with the dosage consisting essentially of estrogen for the period of 2 to 8 consecutive days, (ii) intermittently, (iii) one time, or (iv) once weekly.

11. The method of claim 10 , wherein the combination of the dosage consisting essentially of estrogen and the antidepressant that is administered for the period of 2 to 8 consecutive days is administered for a period of 5 to 8 consecutive days.

12. The method of claim 11 , wherein the antidepressant administered in combination with the estrogen for the period of 5 to 8 consecutive days is administered in a daily amount equivalent to about 5 mg to about 120 mg of fluoxetine hydrochloride.

13. The method of claim 10 , wherein a one-time dose of the antidepressant is administered in combination with the dosage consisting essentially of estrogen.

14. The method of claim 10 , wherein the antidepressant is fluoxetine hydrochloride.

15. The method of claim 1 , wherein the dosage comprising the combination of estrogen and progestin that is administered for the period of 81 to 89 consecutive days, and the dosage consisting essentially of estrogen that is administered for the period of 2 to 8 consecutive days, are administered orally.

16. The method of claim 1 , wherein the dosage comprising the combination of estrogen and progestin that is administered for the period of 81 to 89 consecutive days, and the dosage consisting essentially of estrogen that is administered for the period of 2 to 8 consecutive days, are administered transdermally.

17. A method of contraception in a female in need thereof, the method comprising administering to the female a dosage comprising a combination of estrogen and progestin for a period of 84 consecutive days, followed by administration of a dosage consisting essentially of estrogen for a period of 7 consecutive days,

wherein the estrogen that is administered in combination with progestin for the period of 84 consecutive days is orally administered monophasicly in a daily amount of about 10 μg to about 50 μg of ethinyl estradiol,

the estrogen that is administered for the period of 7 consecutive days is orally administered monophasicly in a daily amount of about 10 μg of ethinyl estradiol, and

the progestin that is administered in combination with estrogen for the period of 84 consecutive days is orally administered monophasicly in a daily amount of about 150 μg of levonorgestrel.

18. A method of contraception in a female in need thereof, the method comprising administering to the female a dosage comprising a combination of estrogen and progestin for a period of 84 consecutive days, followed by administration of a dosage consisting essentially of estrogen for a period of 7 consecutive days,

wherein the estrogen that is administered in combination with progestin for the period of 84 consecutive days is orally administered monophasicly in a daily amount of about 10 μg to about 30 μg of ethinyl estradiol,

the estrogen that is administered for the period of 7 consecutive days is orally administered monophasicly in a daily amount of about 10 μg of ethinyl estradiol, and

the progestin that is administered in combination with estrogen for the period of 84 consecutive days is orally administered monophasicly in a daily amount of about 150 μg of levonorgestrel.

19. A method of contraception in a female in need thereof the method comprising administering to the female a dosage comprising a combination of estrogen and progestin for a period of 84 consecutive days, followed by administration of a dosage consisting essentially of estrogen for a period of 7 consecutive days,

wherein the estrogen that is administered in combination with progestin for the period of 84 consecutive days is orally administered monophasicly in a daily amount of about 30 μg of ethinyl estradiol,

the estrogen that is administered for the period of 7 consecutive days is orally administered monophasicly in a daily amount of about 10 μg of ethinyl estradiol, and

the progestin that is administered in combination with estrogen for the period of 84 consecutive days is orally administered monophasicly in a daily amount of about 150 μg of levonorgestrel.

Assignments (6)
CHANGE OF NAME Recorded May 19, 2010
From: DURAMED PHARMACEUTICALS, INC.
To: TEVA WOMEN'S HEALTH, INC.
Reel/Frame 024402/0984 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 25, 2005
From: BARR LABORATORIES, INC.
To: DURAMED PHARMACEUTICALS, INC.
Reel/Frame 015824/0605 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 3, 2003
From: BELL, ROBERT G.; BEN-MAIMON, CAROLE; ISKOLD, BEATA
To: BARR LABORATORIES, INC.
Reel/Frame 013773/0811 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 3, 2003
From: BELL, ROBERT G.; BEN-MAIMON, CAROLE; ISKOLD, BEATA
To: BARR LABORATORIES, INC.
Reel/Frame 013773/0835 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 3, 2003
From: BELL, ROBERT G.; BEN-MAIMON, CAROLE; ISKOLD, BEATA
To: BARR LABORATORIES, INC.
Reel/Frame 013773/0851 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 3, 2003
From: BELL, ROBERT G.; BEN-MAIMON, CAROLE; ISKOLD, BEATA
To: BARR LABORATORIES, INC.
Reel/Frame 013773/0860 →