CA2468748A1 - Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology - Google Patents

Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology Download PDF

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Publication number
CA2468748A1
CA2468748A1 CA002468748A CA2468748A CA2468748A1 CA 2468748 A1 CA2468748 A1 CA 2468748A1 CA 002468748 A CA002468748 A CA 002468748A CA 2468748 A CA2468748 A CA 2468748A CA 2468748 A1 CA2468748 A1 CA 2468748A1
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Prior art keywords
estrogen
administered
period
consecutive days
combination
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CA002468748A
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French (fr)
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CA2468748C (en
Inventor
Robert G. Bell
Carole Ben-Maimon
Beata Iskold
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Teva Womens Health Inc
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Priority to CA2655959A priority Critical patent/CA2655959C/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/567—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in position 17 alpha, e.g. mestranol, norethandrolone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/18—Feminine contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/30—Oestrogens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/34—Gestagens

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 regimen s in combination with an antidepressant and a kit containing the same.

Claims (92)

1. A method of diminishing a premenstrual symptom in a female in need thereof, said method comprising administering to said female a combination of estrogen and progestin for a period of 60 to 110 consecutive days, followed by administration of estrogen for a period of 2 to 10 consecutive days.
2. The method of claim 1, wherein the combination of estrogen and progestin is administered for a period of 81 to 89 consecutive days.
3. The method of claim 2, wherein the estrogen that is administered in combination with progestin for a period of 81 to 89 consecutive days is administered in a daily amount equivalent to about 5 µg to about 50 µg of ethinyl estradiol.
4. The method of claim 3, wherein the estrogen that is administered for a period of 2 to 10 consecutive days is administered in a daily amount equivalent to about 5 µg to about 50 µg of ethinyl estradiol.
5. The method of claim 4, wherein the progestin that is administered in combination with estrogen for a period of 81 to 89 consecutive days is administered in a daily amount equivalent to about 0.05 mg to about 1.5 mg of levonorgestrel.
6. The method of claim 5, wherein the combination of estrogen and progestin is administered for at least 84 consecutive days.
7. The method of claim 1, wherein the estrogen that is administered for a period of 2 to 10 consecutive days is administered for a period of 5 to
8 consecutive days.

8. The method of claim 7, wherein the estrogen that is administered for a period of 5 to 8 consecutive days is administered for at least 7 consecutive days.
9. The method of claim 5, in which the estrogen is ethinyl estradiol.
10. The method of claim 9, in which the progestin is levonorgestrel.
11. The method of claim 1, wherein said premenstrual symptom is selected from the group consisting of irritability, mood swings, depression, hostility, social withdrawal, bloating, breast tenderness, myalgia, migraine, headache, fatigue, anger, and tension.
12. The method of claim 1, wherein said female has Premenstrual Dysphoric Disorder (PMDD).
13. A method of diminishing a premenstrual symptom in a female in need thereof, said method comprising administering to said female a combination of estrogen and progestin for a period of 60 to 110 consecutive days, followed by administration of estrogen for a period of 2 to 10 consecutive days, wherein an antidepressant is administered (i) in combination with the estrogen for the period of 2 to 10 consecutive days, (ii) intermittently, (iii) one time, or (iv) once weekly.
14. The method of claim 13, wherein the combination of estrogen and progestin is administered for a period of 81 to 89 consecutive days.
15. The method of claim 13, wherein the antidepressant that is administered in combination with the estrogen for the period of 2 to 10 consecutive days (i) is administered for a period of 5 to 8 consecutive days.
16. The method of claim 15, 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 5 µg to about 50 µg of ethinyl estradiol.
17. The method of claim 15, wherein the estrogen that is administered in combination with the antidepressant for the period of 5 to 8 consecutive days is administered in a daily amount equivalent to about 5 µg to about 50 µg of ethinyl estradiol.
18. The method of claim 17, wherein the progestin that is administered in combination with estrogen for the period of 81 to 89 consecutive days is administered in a daily amount equivalent to about 0.05 mg to about 1.5 mg of levonorgestrel.
19. The method of claim 18, in which 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.
20. The method of claim 14, wherein the combination of estrogen and progestin that is administered for the period of 81 to 89 consecutive days is administered for at least 84 consecutive days.
21. The method of claim 15, wherein the combination of estrogen and antidepressant that is administered for the period of 5 to 8 consecutive days is administered for at least 7 consecutive days.
22. The method of claim 19, in which the estrogen is ethinyl estradiol.
23. The method of claim 22, in which the progestin is levonorgestrel.
24. The method of claim 23, in which the antidepressant is fluoxetine hydrochloride.
25. The method of claim 13, wherein the antidepressant is administered in combination with the estrogen or the combination of estrogen and progestin in a single tablet.
26. The method of claim 13, wherein the antidepressant is administered one time in combination with one dose of the estrogen or one dose of the combination of estrogen and progestin.
27. The method of claim 13, wherein the premenstrual symptom is selected from the group consisting of irritability, mood swings, depression, hostility, social withdrawal, bloating, breast tenderness, myalgia, migraine, headache, fatigue, anger, and tension.
28. The method of claim 13, wherein said female has Premenstrual Dysphoric Disorder (PMDD).
29. A method of diminishing a premenstrual symptom in a female in need thereof, said method comprising administering to said female a combination of estrogen and progestin for a period of 21 to 26 consecutive days, followed by administration of estrogen for a period of 2 to 10 consecutive days, wherein an antidepressant is administered (i) in combination with the estrogen for the period of 2 to 10 consecutive days, (ii) intermittently, (xii) one time, or (iv) once weekly.
30. The method of claim 29, wherein the combination of estrogen and progestin that is administered for the period of 21 to 26 consecutive days is administered for a period of 22 to 25 consecutive days.
31. The method of claim 30, wherein the combination of estrogen and an antidepressant that is administered for the period of 2 to 10 consecutive days is administered for a period of 2 to 7 consecutive days.
32. The method of claim 31, wherein the estrogen that is administered in combination with progestin for the period of 22 to 25 consecutive days is administered in a daily amount equivalent to about 5 µg to about 50 µg of ethinyl estradiol.
33. The method of claim 32, wherein the estrogen that is administered in combination with the antidepressant for the period of 2 to 7 consecutive days is administered in a daily amount equivalent to about 5 µg to about 50 µg of ethinyl estradiol.
34. The method of claim 33, wherein the progestin that is administered in combination with estrogen for the period of 22 to 25 consecutive days is administered in a daily amount equivalent to about 0.05 mg to about 1.5 mg of levonorgestrel.
35. The method of claim 34, wherein the antidepressant that is administered in combination with the estrogen for the period of 2 to 7 consecutive days is administered in a daily amount equivalent to about 5 mg to about 120 mg of fluoxetine hydrochloride.
36. The method of claim 31, wherein the combination of estrogen and progestin that is administered for the period of 22 to 25 consecutive days is administered for 25 consecutive days.
37. The method of claim, 36, wherein the combination of estrogen and antidepressant that is administered for the period of 2 to 7 consecutive days is administered for 7 consecutive days.
38. The method of claim 36, wherein the estrogen is ethinyl estradiol.
39. The method of claim 33, wherein the progestin is levonorgestrel.
40. The method of claim 37, wherein the estrogen is ethinyl estradiol, the progestin is levonorgestrel, and the antidepressant is fluoxetine hydrochloride,
41. The method of claim 29, wherein the antidepressant is administered in combination with the estrogen or the combination of estrogen and progestin in a single tablet.
42. The method of claim 41, wherein the antidepressant is administered in combination with one dose of the estrogen or one dose of the combination of estrogen and progestin.
43. The method of claim 29, wherein the premenstrual symptom is selected from the group consisting of irritability, mood swings, depression, hostility, social withdrawal, bloating, breast tenderness, myalgia, migraine, headache, fatigue, anger, and tension.
44. The method of claim 29, wherein said female has Premenstrual Dysphoric Disorder (PMDD).
45. A method of diminishing an estrogen withdrawal symptom in a female in need thereof, said method comprising administering to said female a combination of estrogen and progestin for a period of 60 to 110 consecutive days, followed by administration of estrogen for a period of 2 to 10 consecutive days.
46. The method of claim 45, wherein the estrogen withdrawal symptom is selected from the group consisting of headache, migraine, breast tenderness, bloating, and abdominal pain.
47. The method of claim 45, wherein an antidepressant is administered (i) in combination with the estrogen for the period of 2 to 10 consecutive days, (ii) intermittently, (iii) one time, or (iv) once weekly.
48. The method of claim 45, wherein:
the estrogen that is administered in combination with progestin for the period of 60 to 110 consecutive days is administered in a daily amount equivalent to about 5 µg to about 50 µg of ethinyl estradiol;
the estrogen that is administered for the period of 2 to 10 consecutive days is administered in a daily amount equivalent to about 5 µg to about 50 µg of ethinyl estradiol; and the progestin that is administered in combination with estrogen for the period of 60 to 110 consecutive days is administered in a daily amount equivalent to about 0.05 mg to about 1.5 mg of levonorgestrel.
49. The method of claim 48, wherein:
the estrogen that is administered in combination with progestin for the period of 60 to 110 consecutive days is ethinyl estradiol;

the estrogen that is administered for the period of 2 to 10 consecutive days is ethinyl estradiol; and the progestin that is administered in combination with estrogen for the period of 60 to 110 consecutive days is levonorgestrel.
50. The method of claim 47, wherein:
the estrogen that is administered in combination with progestin for the period of 60 to 110 consecutive days is administered in a daily amount equivalent to about 5 µg to about 50 µg of ethinyl estradiol;
the progestin that is administered in combination with estrogen for the period of 60 to 110 consecutive days is administered in a daily amount equivalent to about 0.05 mg to about 1.5 mg of levonorgestrel;
the estrogen that is administered for the period of 2 to 10 consecutive days is administered in a daily amount equivalent to about 5 µg to about 50 µg of ethinyl estradiol; and the antidepressant that is administered in combination with estrogen for the period of 2 to 10 consecutive days is administered in a daily amount equivalent to about 5 mg to about 120 mg of fluoxetine hydrochloride.
51. The method of claim 50, wherein:
the estrogen that is administered in combination with progestin for the period of 60 to 110 consecutive days is ethinyl estradiol;
the estrogen that is administered for the period of 2 to 10 consecutive days is ethinyl estradiol;
the progestin that is administered in combination with estrogen for the period of 60 to 110 consecutive days is levonorgestrel; and the antidepressant that is administered in combination with estrogen for the period of 2 to 10 consecutive days is fluoxetine hydrochloride.
52 52. A method of diminishing an estrogen withdrawal symptom in a female in need thereof, said method comprising administering to said female a combination of estrogen and progestin for a period of 21 to 26 consecutive days, followed by administration of estrogen for a period of 2 to 10 consecutive days.
53. The method of claim 52, wherein the estrogen withdrawal symptom is selected from the group consisting of headache, migraine, breast tenderness, bloating, and abdominal pain.
54. The method of claim 52, wherein an antidepressant is administered (i) in combination with the estrogen for the period of 2 to 10 consecutive days, (ii) intermittently, (iii) one time, or (iv) once weekly.
55. A kit comprising: (a) 60-110 tablets comprising estrogen and progestin optionally combined with an antidepressant; and (b) 2-10 tablets comprising estrogen optionally combined with an antidepressant.
56. The kit of claim 55, wherein the tablets comprising estrogen and progestin optionally combined with the antidepressant include 81 to 89 tablets, and wherein the tablets comprising estrogen optionally combined with the antidepressant include 2 to 7 tablets.
57. A kit comprising: (a) 21-26 tablets comprising estrogen and progestin optionally combined with an antidepressant; and (b) 2-10 tablets comprising estrogen optionally combined with an antidepressant.
58. The kit of claim 55, wherein the estrogen in each of the tablets comprising estrogen and progestin optionally combined with the antidepressant is present in an amount equivalent to about 5 µg to about 50 µg of ethinyl estradiol, and wherein the estrogen in each of the tablets comprising estrogen 44.

optionally combined with the antidepressant is present in an amount equivalent to about 5 µg to about 50 µg of ethinyl estradiol.
59. The kit of claim 58, wherein the progestin in each of the tablets comprising estrogen and progestin optionally combined with the antidepressant is present in an amount equivalent to about 0.05 mg to about 1.5 mg of levonorgestrel.
60. The kit of claim 55, wherein the tablets comprising estrogen in (b) include the antidepressant in all tablets, some tablets, one tablet or once-weekly tablet.
61. The kit of claim 60, wherein the tablets comprising estrogen and progestin include about 84 tablets, and wherein the tablets comprising estrogen and the antidepressant include about 7 tablets.
62. The kit of claim 57, wherein the tablets comprising estrogen and progestin optionally combined with the antidepressant include 22 to 25 tablets, and wherein the tablets comprising estrogen optionally combined with the antidepressant include 2 to 7 tablets.
63. The kit of claim 60, wherein;
the estrogen in each of the tablets comprising estrogen and progestin is present in an amount equivalent to about 5 µg to about 50 µg of ethinyl estradiol;
the estrogen in each of the tablets comprising estrogen combined with the antidepressant, is present in an amount equivalent to about 5 µg to about 50 µg of ethinyl estradiol;
the progestin in each of the tablets comprising estrogen and progestin is present in an amount equivalent to about 0.05 mg to about 1.5 mg of levonorgestrel; and the antidepressant in each of the tablets comprising estrogen and antidepressant is present in an amount equivalent to about 5 mg to about 120 mg of fluoxetine hydrochloride.
64. A preparation comprising about 60 to about 110 dosage forms comprising a combination of estrogen and progestin, and about 2 to about 10 dosage forms comprising estrogen.
65. The preparation of claim 64, wherein the about 60 to about 110 dosage forms or the about 2 to about 10 dosage forms are combined with an antidepressant for all dosage forms, some dosage forms, one dosage form, or once-weekly dosage form.
66. A preparation comprising about 21 to about 26 dosage forms comprising a combination of estrogen, and progestin and about 2 to about 10 dosage forms comprising estrogen.
67. The preparation of claim 66, wherein the about 2 to about 10 dosage forms comprise estrogen combined with an antidepressant for all dosage forms, some dosage forms, one dosage form, or once-weekly dosage form.
68. A method of contraception in a female in need thereof, said method comprising administering to said female a combination of estrogen and progestin for a period of 60 to 110 consecutive days, followed by administration of estrogen for a period of 2 to 10 consecutive days.
69. The method of claim 68, wherein the combination of estrogen and progestin that is administered for the period of 60 to 110 consecutive days is administered for a period of 81 to 89 consecutive days.
70. The method of claim 69, wherein the estrogen that is administered for the period of 81 to 89 consecutive days is administered in a daily amount equivalent to about 5 µg to about 50 µg of ethinyl estradiol.
71. The method of claim 69, wherein the estrogen, that is administered for the period of 2 to 10 consecutive days is administered in a daily amount equivalent to about 5 µg to about 50 µg of ethinyl estradiol.
72. The method of claim 70, wherein the progestin that is administered in combination with estrogen for the period of 81 to 89 consecutive days is administered in a daily amount equivalent to about 0.05 mg to about 1.5 mg of levonorgestrel.
73. A method of contraception in a female in need thereof, said method comprising administering to said female a combination of estrogen and progestin for a period of 60 to 110 consecutive days, followed by administration of estrogen for a period of 2 to 10 consecutive days, wherein as antidepressant is administered (i) in combination with the estrogen for the period of 2 to 10 consecutive days, (ii) intermittently, (iii) one tinge, or (iv) once weekly
74. The method of claim 73, wherein the combination of estrogen and progestin that is administered for the period of 60 to 110 consecutive days is administered for a period of 81 to 89 consecutive days.
75. The method of claim 73, wherein the combination of estrogen and antidepressant that is administered for the period of 2 to 10 consecutive days is administered for a period of 5 to 8 consecutive days.
76. The method of claim 74, 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 5 µg to about 50 µg of ethinyl estradiol.
77. The method of claim 74, wherein the estrogen that is administered in combination with antidepressant for the period of 5 to 8 consecutive days is administered in a daily amount equivalent to about 5 µg to about 50 µg of ethinyl estradiol.
78. The method of claim 77, wherein the progestin that is administered in combination with estrogen for the period of 81 to 89 consecutive days is administered in a daily amount equivalent to about 0.05 mg to about 1.5 mg of levonorgestrel.
79. The method of claim 78, 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.
80. The method of claim 73, wherein a one-time dose of an antidepressant is administered in combination with the estrogen.
81. A method of contraception in a female in need thereof, said method comprising administering to said female a combination of estrogen and progestin for a period of 21 to 26 consecutive days, followed by administration of estrogen for a period of 2 to 10 consecutive days, wherein an antidepressant is administered (i) in combination with the estrogen for the period of 2 to 10 consecutive days, (ii) intermittently, (iii) one time, or (iv) once weekly.
82. The method of claim 81, wherein the estrogen that is administered in combination with progestin for the period of 21 to 26 consecutive days is administered in a daily amount equivalent to about 5 µg to about 50 µg of ethinyl estradiol.
83. The method of claim 82, wherein the estrogen that is administered in combination with antidepressant for the period of 2 to 10 consecutive days is administered in a daily amount equivalent to about 5 µg to about 50 µg of ethinyl estradiol.
84. The method of claim 83, wherein the progestin that is administered in combination with estrogen for the period of 21 to 26 consecutive days is administered in a daily amount equivalent to about 0.05 mg to about 1.5 mg of levonorgestrel.
85. The method of claim 84, wherein the antidepressant that is administered in combination with estrogen for the period of 2 to 10 consecutive days is administered in a daily amount equivalent to about 5 mg to about 220 mg of fluoxetine hydrochloride.
86. The method of claim 83, wherein the estrogen is ethinyl estradiol, the progestin is levonorgestrel, and the antidepressant is fluoxetine hydrochloride.
87. The method of claim 81, wherein the antidepressant is administered in combination with the estrogen or the combination of estrogen and progestin in a single tablet.
88. The method of claim 81, wherein the antidepressant is administered in combination with one dose of the estrogen or one dose of the combination of estrogen and progestin.
89. The method of claim 52, wherein the combination of estrogen and progestin is administered for a period of 25 consecutive days, and the combination of estrogen and antidepressant is administered for a period of 3 consecutive days.
90. A method of contraception in a female in need thereof, said method comprising administering to said female a combination of estrogen and progestin for a period of 25 consecutive days, followed by administration of estrogen of a period of 3 consecutive days.
91, A method of diminishing a premenstrual symptom in a female in need thereof, said method comprising administering to said female a combination of estrogen and progestin for a period of 25 consecutive days, followed by administration of estrogen of a period of 3 consecutive days.
92. The kit of claim 62, wherein the tablets comprising estrogen and progestin optionally combined with the antidepressant include 25 tablets, and wherein the tablets comprising estrogen optionally combined with the antidepressant include 3 tablets.
CA2468748A 2001-12-05 2002-12-04 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology Expired - Lifetime CA2468748C (en)

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CA2655959A CA2655959C (en) 2001-12-05 2002-12-04 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology

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US33580701P 2001-12-05 2001-12-05
US60/335,807 2001-12-05
PCT/US2002/038602 WO2003049744A1 (en) 2001-12-05 2002-12-04 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology

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EP (3) EP1453521B1 (en)
JP (3) JP2005516913A (en)
CN (2) CN101757628A (en)
AU (2) AU2002348272B2 (en)
BG (1) BG108736A (en)
BR (1) BRPI0214716B8 (en)
CA (2) CA2655959C (en)
DK (1) DK1453521T3 (en)
ES (2) ES2428118T3 (en)
HK (2) HK1076716A1 (en)
HU (2) HU230759B1 (en)
IL (3) IL162182A0 (en)
LU (1) LU93156I2 (en)
MX (1) MXPA04005445A (en)
NZ (4) NZ555299A (en)
PL (1) PL213122B1 (en)
PT (1) PT1453521E (en)
RU (1) RU2351339C2 (en)
SI (1) SI1453521T1 (en)
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US8415332B2 (en) 2004-10-07 2013-04-09 TEVA Woman's Health, Inc. Methods of hormonal treatment utilizing ascending-dose extended cycle regimens

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