Method of hormonal contraception

• US 5,662,927 A
• Filed: 12/21/1994
• Issued: 09/02/1997
• Est. Priority Date: 12/24/1993
• Status: Expired due to Fees

• Current Assignee: Herbert Kuhl, Marika Ehrlich
• Original Assignee: Herbert Kuhl, Marika Ehrlich
• Inventors: Kuhl, Herbert, Ehrlich, Marika
• Primary Examiner(s): Phelan, D. Gabrielle
• Application Number:
  US08/360,297
• Time in Patent Office: 986 Days
• Field of Search: 424/449, 424/464, 514/170, 514/843
• US Class Current: 424/449
• 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 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/18 Feminine contraceptives
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/10 Anti-acne agents

Abstract

A method for hormonal contraception having a first hormonal component and a second hormonal component packaged separately in a packing unit and intended for short-term sequential administration, each of the hormonal components being composed of a plurality of daily hormone units separately packaged and individually removable in the packing unit. The first hormonal component contains almost exclusively an estrogen preparation as an active hormonal ingredient, effecting a disturbance of the follicle stimulation. The second hormonal component contains, in combination, an estrogen preparation and a progestogen preparation in a therapeutic amount sufficient for ovulation inhibition. The total number of daily hormone units is equal to the total number of days of the desired cycle, with the first hormonal component including 5 or 14 daily units and the second hormonal component including 23 or 14 daily units. The plurality of daily units of the first hormonal component is lower than the plurality of daily units of the second hormonal component, characterized by such an arrangement of the daily units in the packaging unit that the daily units of the second hormonal component are taken first and the daily units of the first hormonal component are taken thereafter. The daily units of the second hormonal component do not contain the combination of biologically produced estrogen and synthetic estrogen.

Claims

1. A method of hormonal contraception comprising the steps of:

sequentially administering a composition for the total number of days of a desired cycles beginning with the first day of menstruation that includes a first hormonal component and a second hormonal component, the first hormonal component composed of a plurality of daily hormone units including a therapeutically effective amount of an estrogen preparation to cause disturbance of the follicle stimulation, the second hormonal component composed of a plurality of daily hormone units including a therapeutically effective amount of an estrogen preparation and a progestogen preparation to inhibit ovulation, the estrogen preparation of the second hormonal component not being a combination of a biologically produced estrogen and a synthetic estrogen;

separately packaging the first hormonal component and the second hormonal component in a joint packaging unit in separate packages which are individually removable from the joint packaging unit, with the plurality of daily hormone units equaling the total number of days of the desired cycle;

providing the daily units of the first hormonal component in a plurality which is lower that the plurality of daily units of the second hormonal component; and

arranging the plurality of daily units of the second hormonal component in the joint packaging unit to cause a first daily unit of the second hormonal component to be administered on the first day of menstruation and further to cause said plurality daily units of the second hormonal component to be taken before the plurality of daily units of the first hormonal component.

2. The method of claim 1 further comprising the step of providing 5 daily hormone units in the first hormonal component and 23 daily hormone units in the second hormonal component.

3. The method of claim 1 further comprising the step of providing 14 daily units in the first hormonal component and 14 daily units in the second hormonal component.

4. The method of claim 1 further comprising the step of administering a first daily hormone unit of the second hormonal component on the first day of the cycle.

5. The method of claim 1 further comprising the step of continuously numbering the plurality of daily hormone units of the first hormonal component and the plurality of daily hormone units of the second hormonal component according to the total number of administration days of the desired cycle.

6. The method of claim 5 further comprising the step of fixing the numbering of daily hormone units.

7. The method of claim 5 further comprising the step of varying the numbering of daily hormone units such that the first administration day can be optionally assigned to the first daily hormone unit of the first hormonal component or the first daily hormone unit of the second hormonal component.

8. The method of claim 1 further comprising the step of administering at least one of the hormonal components orally.

9. The method of claim 1 further comprising the step of administering at least one of the hormonal components transdermally.

10. The method of claim 1 further comprising the step of combining the plurality of daily hormone units of at least one of the hormonal components to form a sustained release unit.

11. The method of claim 1 further comprising the step of separately packaging in the joint packaging unit at least two pairs of the first hormonal component and the second hormonal component.

12. The method of claim 1 further comprising the step of including an incrementally increasing estrogen preparation in the daily units of the second hormonal component.

13. A joint packaging unit for the administration of a hormonal contraceptive, the joint packaging unit comprising:

a first hormonal component including a plurality of daily hormone units which contain a therapeutically effective amount of an estrogen preparation to cause disturbance of the follicle stimulation;

a second hormonal component including a plurality of daily hormone units which contain a therapeutically effective combination of an estrogen preparation and a progestogen preparation to inhibit ovulation, the estrogen preparation not including a combination of a biologically produced estrogen and a synthetic estrogen;

the plurality of daily hormone units of the first hormonal component and the plurality of daily hormone units of the second hormonal component equaling a total number of days of a desired cycle;

the first hormonal component and the second hormonal component being separately packaged in respective packages within the joint packaging unit, the separate packages being individually removable from the joint packaging unit;

the plurality of daily units of the second hormonal component being arranged in the joint packaging unit such that the plurality of daily units of the second hormonal component are available to be removed from the joint packaging unit before the plurality of daily units of the first hormonal component;

the plurality of daily units of the second hormonal component being further arranged so that a first daily unit of the second hormonal component is available to be removed on the first day of the menstruation; and

the plurality of daily hormone units of the second hormonal component is less than the plurality of daily hormone units of the first hormonal component.

14. The joint packaging unit of claim 13 wherein the first hormonal component includes 5 daily hormone units and the second hormonal component includes 23 daily hormone units.

15. The joint packaging unit of claim 13 wherein the first hormonal component includes 14 daily hormone units and the second hormonal component includes 14 daily hormone units.

16. The joint packaging unit of claim 13 wherein a first daily hormone unit of the second hormonal component is administered on the first day of the desired cycle.

17. The joint packaging unit of claim 13 wherein the plurality of daily hormone units of the first hormonal component and plurality of daily hormone units of the second hormonal component are continuously numbered according to the total number of administration days of the desired cycle.

18. The joint packaging unit of claim 17 wherein the numbering of the daily hormone units is fixed.

19. The joint packaging unit of claim 17 wherein the numbering of daily hormone units is variable such that the first administration day can be optionally assigned to the first daily hormone unit of the first hormonal component or the first daily hormone unit of the second hormonal component.

20. The joint packaging unit of claim 13 wherein at least one of the hormonal components is for oral administration.

21. The joint packaging unit of claim 13 wherein at least one of the hormonal components is for transdermal administration.

22. The joint packaging unit of claim 13 further comprising a sustained release unit formed from combining the plurality of daily hormone units of at least one of the hormonal components.

23. The joint packaging unit of claim 13 wherein at least two pairs of the first hormonal component and the second hormonal component are separately packaged in the common packaging unit.

24. The joint packaging unit of claim 13 wherein the daily units of the plurality of daily units of the second hormonal component include an incrementally increasing estrogen preparation.