Low dose oral contraceptives with less breakthrough bleeding and sustained efficacy

• US 5,552,394 A
• Filed: 07/22/1994
• Issued: 09/03/1996
• Est. Priority Date: 07/22/1994
• Status: Expired due to Term

• Current Assignee: Warner Chilcott Company LLC (Abbvie Incorporated)
• Original Assignee: The Medical College of Hampton Roads
• Inventors: Hodgen, Gary D.
• Primary Examiner(s): JORDAN, KIMBERLY R
• Application Number:
  US08/279,300
• Time in Patent Office: 774 Days
• Field of Search: 514/170, 514/178, 514/182, 514/843
• US Class Current: 514/178
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/567 substituted in position 17 alpha, e.g. mestranol, norethandrolone

Abstract

A method of female contraception which is characterized by a reduced incidence of breakthrough bleeding after the first cycle involves monophasicly administering a combination of estrogen and progestin for 23-25 consecutive days of a 28 day cycle in which the daily amounts of estrogen and progestin are equivalent to about 5-35 mcg of ethinyl estradiol and about 0.025 to 10 mg of norethindrone acetate, respectively and in which the weight ratio of estrogen to progestin is at least 1:45 calculated as ethinyl estradiol to norethindrone acetate.

Claims

1. A method of female contraception which is characterized by a reduced incidence of breakthrough bleeding after the first cycle which comprises monophasicly administering a combination of estrogen and progestin for 23-25 consecutive days of a 28 day cycle in which the daily amounts of estrogen and progestin are equivalent to about 1-35 mcg of ethinyl estradiol and about 0.025 to 10 mg of norethindrone acetate, respectively, and in which the weight ratio of estrogen to progestin is at least 1:

45 calculated as ethinyl estradiol to norethindrone acetate.

2. The method of claim 1 in which the daily amount of progestin is equivalent to 0.5-0.75 mg of norethindrone acetate.

3. The method of claim 2 in which the weight ratio is at least 1:

50.

4. The method of claim 3 in which the combination is administered for 24 days of the 28 day cycle.

5. The method of claim 4 in which the estrogen is ethinyl estradiol.

6. The method of claim 5 in which the progestin is norethindrone acetate.

7. The method of claim 1 in which the daily amount of progestin is equivalent to 0.5-1.5 mg of norethindrone acetate.

8. The method of claim 1 in which the weight ratio is at least 1:

50.

9. The method of claim 1 in which the combination is administered for 24 days of the 28 day cycle.

10. The method of claim 1 in which the estrogen is ethinyl estradiol.

11. The method of claim 1 in which the progestin is norethindrone acetate.

12. The method of claim 1 in which the daily amount of estrogen is up to 30 mcg of ethinyl estradiol.