Therapeutic methods and delivery systems utilizing sex steroid precursors

• US 5,807,849 A
• Filed: 06/13/1995
• Issued: 09/15/1998
• Est. Priority Date: 01/19/1993
• Status: Expired due to Term

• Current Assignee: Endorecherche
• Original Assignee: Endorecherche
• Inventors: Labrie, Fernand
• Primary Examiner(s): Dees, Jose G.
• Assistant Examiner(s): TILL, MARY C
• Application Number:
  US08/489,909
• Time in Patent Office: 1,190 Days
• Field of Search: 514/178
• 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 31/566 having an oxo group in position 17, e.g. estrone
• CPC Class Codes: A61K 31/5685 having an oxo group in position 17, e.g. androsterone
• 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: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61P 13/00 Drugs for disorders of the urinary system
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/02 for disorders of the vagina
• CPC Class Codes: A61P 15/12 for climacteric disorders
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 19/10 for osteoporosis
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/00 Drugs for disorders of the endocrine system
• CPC Class Codes: A61P 5/24 of the sex hormones
• CPC Class Codes: A61P 5/26 Androgens
• CPC Class Codes: A61P 5/34 : Gestagens
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/12 : Antihypertensives
• CPC Class Codes: C07J 1/0011 : substituted in position 17 by a keto group
• CPC Class Codes: C07J 43/003 : not condensed
• CPC Class Codes: C07J 43/006 : spiro-condensed

Abstract

Sex steroid precursors such as dehydroepiandrosterone and dehydroepiandrosterone sulphate, and compounds converted in vivo to either of the foregoing, are utilized for the treatment and/or prevention of vaginal atrophy, hypogonadism, diminished libido, osteoporosis, urinary incontinence, ovarian cancer, uterine cancer, skin atrophy, for contraception, and, in combination with an estrogen and/or progestin, for the treatment of menopause. The precursors may be formulated for percutaneous or transmucosal administration. Gels, solutions, lotions, creams, ointments and transdermal patches for the administration of these precursors are provided, as are certain pharmaceutical compositions and kits which can be used for the prevention and treatment of a wide variety of conditions related to decreased secretion of sex steroid precursors by the adrenals.

Claims

1. A method for inhibiting the development, or the treatment, of urinary incontinence comprising administering to a patient in need thereof, a therapeutically effective amount of a sex steroid precursor selected from the group consisting of DHEA, DHEA-S, and compounds converted in vivo to either whereby to obtain a serum level of about 4 to 13 micrograms per liter of DHEA.

2. The method of claim 1, wherein said precursor is administered at a dosage sufficient to maintain serum DHEA concentration of said patient between 4 and 10 micrograms per liter.

3. The method of claim 1 wherein said precursor is DHEA.

4. The method of claim 1, further comprising administering a therapeutically effective amount of at least one additional agent selected from the group consisting of an estrogen and a progestin.

5. The method of claim 4, wherein both an estrogen and a progestin are administered.

6. A method for inhibiting the development, or the treatment, of urinary incontinence comprising administering to a patient in need thereof, a therapeutically effective amount of a pharmaceutical comprising a pharmaceutically acceptable diluent or a carrier and a sex steroid precursor selected from the group consisting of DHEA, DHEA-S, and compounds converted in vivo to either whereby to obtain a serum level of about 4 to 13 micrograms per liter of DHEA.

7. The method of claim 6, wherein said composition is administered at a dosage sufficient to maintain serum DHEA concentration of said patient between 4 and 10 micrograms per liter.

8. The method of claim 6, wherein said precursor is DHEA.

9. The method of claim 6, wherein said pharmaceutical composition further comprises therapeutically effective amount of at least one additional agent selected from the group consisting of an estrogen and a progestin.

10. The method of claim 9, wherein said pharmaceutical composition includes both an estrogen and a progestin.