Continuous delivery of luteinizing hormone releasing hormone compositions in combination with sex steroid delivery for use in treating benign ovarian secretory disorders

• US 5,130,137 A
• Filed: 08/09/1989
• Issued: 07/14/1992
• Est. Priority Date: 08/09/1989
• Status: Expired due to Term

• Current Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Original Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Inventors: Crowley, William F. Jr.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Webman, E. J.
• Application Number:
  US07/391,278
• Time in Patent Office: 1,070 Days
• Field of Search: 424/432, 424/423, 424/433, 424/434, 424/435, 424/437, 424/464, 424/45, 424/DIG. 15
• US Class Current: 424/422
• 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 38/09 Luteinising hormone-releasing hormone [LHRH] , i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
• CPC Class Codes: Y10S 424/14 Topical contraceptives and spermacides
• CPC Class Codes: Y10S 424/15 Suppositories

Abstract

This invention is directed to a delivery system and a method useful for the treatment of benign ovarian secretory disorders in female mammals by administering an LHRH composition. The method comprises administering during the entire follicular phase of the menstrual cycle, beginning at the time of menses, an LHRH composition and sufficient levels of an estrogenic steriod to counteract the possibility of side effects which may develop during prolonged therapy with LHRH. Following the follicular phase, at the beginning of the luteal phase, and for the entire course of the luteal phase, the LHRH/estrogenic steroid combination administered during the follicular phase, in combination with a physiological amount of progestational steroid, is administered.

Claims

1. A method for the treatment of a benign ovarian secretory disorder in a female mammal, comprising:

(a) administering via a first delivery system an effective amount of a luteinizing hormone releasing hormone (LHRH) composition and an effective amount of an estrogenic steroid to said female mammal during an induced follicular phase; and

,

(b) replacing said first delivery system at the end of said follicular phase with a second delivery system, wherein said second delivery system administers an effective amount as a luteinizing hormone releasing hormone (LHRH) composition, an effective amount of an estrogenic steroid and an effective amount of a progestational steroid to said female during a simulated luteal phase, until the beginning of menses in said female.

2. The method according to claim 1 wherein said female mammal comprises a human female.

5. The method according to any one of claims 1 or 3, wherein said administration of said first or second delivery system is selected from the group consisting of oral, subcutaneous, intramuscular, intravenous, vaginal, nasal, transdermal or aural routes of administration.

6. The method according to any one of claims 1 or 3, wherein said route of administration is by vaginal means.

7. The method according to claim 6 wherein said vaginal means is by a vaginal ring delivery system.

8. The method according to claim 6 wherein said vaginal means is by a suppository.

9. The method according to any one of claims 1 or 3, wherein said benign ovarian secretory disorder is polycystic ovarian disease.

10. The method according to any one of claims 1 or 3, wherein said benign ovarian secretory disorder is characterized by excessive ovarian progesterone secretion.

11. The method according to any one of claims 1 or 3, wherein said benign ovarian secretory disorder is characterized by excessive ovarian estrogen secretion.

12. The method according to claim 1, wherein said benign ovarian secretory disorder is characterized by hyperthecosis.

13. The method according to claim 1, wherein said benign ovarian secretory disorder is characterized by hirsutism.

14. The method according to claim 1, wherein said benign ovarian secretory disorder is characterized by dysfunctional uterine bleeding.

15. The method according to claim 1, wherein said benign ovarian secretory disorder is characterized by amenorrhea.

3. A method for the treatment of a benign ovarian secretory disorder in a female mammal, comprising:

(a) administering via a first delivery system an effective amount of a luteinizing hormone releasing hormone (LHRH) composition and an effective amount of an estrogenic steroid to said female mammal during induced diestrus and proestrus phases; and

,

(b) replacing said first delivery system at the end of said diestrus and proestrus phase with a second delivery system, wherein said second delivery system administers a luteinizing hormone releasing hormone (LHRH) composition, an effective amount of an estrogenic steroid and an effective amount of a progestational steroid to said female during simulated estrus and metestrus phases.

4. The method according to claim 3, wherein said female mammal is bovine.

16. The method according to claim 3, wherein said benign ovarian secretory disorder is characterized by anestrus.

17. A method for increasing the breeding rate of an animal, wherein said animal is induced to breed by the method of claim 3.