# US 10,478,443 B2 · Sex steroid precursors alone or in combination with selective estrogen receptor modulators for the prevention and treatment of sexual dysfunction in postmenopausal women

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- Number: US 10,478,443 B2
- Document ID: US10478443B2
- Status: Granted
- Kind: B2
- Application number: 15/991,313
- Filed: 2018-05-29
- Published: 2018-09-27
- Granted: 2019-11-19
- Earliest claimed: 2004-10-20
- Assignees: Endorecherche, Inc.
- Applicants: Endorecherche, Inc.
- Inventors: Mohamed El-Alfy; Fernand Labrie; Louise Berger
- Web page: https://patentgrep.com/patent/US10478443B2

## CPC

- A61K 31/5685: having an oxo group in position 17, e.g. androsterone
- A61K 31/453: containing a six-membered ring with oxygen as a ring hetero atom
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 31/566: having an oxo group in position 17, e.g. estrone
- A61P 5/26: Androgens
- A61P 5/30: Oestrogens
- A61P 5/32: Antioestrogens
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 15/02: for disorders of the vagina
- A61P 15/12: for climacteric disorders
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Novel methods for treating or reducing the likelihood of acquiring vaginal dysfunctions, more particularly vaginal dryness and dyspareunia, leading to sexual dysfunction and low sexual desire and performance, in susceptible warm-blooded animals including humans involving administration of a sex steroid precursor. Further administration of estrogen or selective estrogen receptor modulator, particularly those selected from the group consisting of Raloxifene, Arzoxifene, Tamoxifen, Droloxifene, Toremifene, Iodoxifene, GW 5638, TSE-424, ERA-923, and lasofoxifene, and more particularly compounds having the general structure: is specifically disclosed for the medical treatment and/or inhibition of development of some of these above-mentioned diseases. Pharmaceutical compositions for delivery of active ingredient(s) and kit(s) useful to the invention are also disclosed.

## Claims

### Claim 1

A method of treating or reducing the likelihood of acquiring a vaginal disease or condition caused by the atrophy of either or both of the layer lamina propria and/or the layer muscularis of the vagina in postmenopausal women, wherein said disease or condition is sexual dysfunction other than dyspareunia, said method comprising administering a sex steroid precursor that is dehydroepiandrosterone, to a patient in need of said treatment and also administering to said patient, as part of a combination therapy, a selective estrogen receptor modulator that is:

### Claim 2 (depends on 1)

The method of claim 1, wherein the sex steroid precursor is administered intravaginally.

### Claim 3 (depends on 1)

The method of claim 1, wherein the sex steroid precursor is orally or percutaneously administered.

### Claim 4 (depends on 1)

The method of claim 1 wherein the selective estrogen receptor modulator is orally, percutaneously or intravaginally administered.