# US 9,750,716 B2 · Compounds and forms of treatment for female sexual disorders

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- Number: US 9,750,716 B2
- Document ID: US9750716B2
- Status: Granted
- Kind: B2
- Application number: 15/074,984
- Filed: 2016-03-18
- Published: 2016-09-22
- Granted: 2017-09-05
- Earliest claimed: 2015-03-19
- Applicants: Wendy Anne Epstein
- Inventors: Wendy Anne Epstein
- Web page: https://patentgrep.com/patent/US9750716B2

## CPC

- A61K 31/353: 3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61K 9/0034: {Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants}
- A61K 31/085: having an ether linkage to aromatic ring nuclear carbon
- A61K 31/355: Tocopherols, e.g. vitamin E
- A61K 31/375: Ascorbic acid, i.e. vitamin C; Salts thereof
- A61K 31/565: not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K 31/566: having an oxo group in position 17, e.g. estrone
- 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 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

The invention provides safe and efficacious treatments for Female Sexual Disorders, genitopelvic pain/penetration disorders, vulvovaginal atrophy, vestibulodynia, dyspareunia, sexual interest/arousal disorder, low female libido, and female orgasmic disorder.

## Claims

### Claim 1

A method for treating a female sexual disorder (FSD), comprising applying a pharmaceutical composition to an individual's vulvovaginal area, wherein said pharmaceutical composition comprises a catechin having an epigallocatechin gallate component, wherein said FSD is selected from the group consisting of genitopelvic pain disorder, vulvovaginal atrophy (VVA), vestibulodynia, dyspareunia, sexual interest arousal disorder (SIAD), and female orgasmic disorder (FOD).

### Claim 2 (depends on 1)

The method of claim 1, wherein said catechin is at a concentration of between about 1% and 10% weight per weight of total composition (w/w).

### Claim 3 (depends on 2)

The method of claim 2, wherein said catechin concentration is between about 2.5% and 10% by weight.

### Claim 4 (depends on 2)

The method of claim 2, wherein said catechin concentration is between about 1% and 7.5% by weight.

### Claim 5 (depends on 1)

The method of claim 1, wherein said catechin is a tea catechin.

### Claim 6 (depends on 1)

The method of claim 1, wherein said catechin is applied to a vulva, a vaginal introitus or a vagina.

### Claim 7 (depends on 1)

The method of claim 1, wherein said pharmaceutical composition further comprises a selective estrogen receptor modulator (SERM).

### Claim 8 (depends on 7)

The method of claim 7, wherein said SERM is ospemifene.

### Claim 9 (depends on 1)

The method of claim 1, wherein said pharmaceutical composition further comprises estrogen.

### Claim 10 (depends on 1)

The method of claim 1, wherein said pharmaceutical composition further comprises a combination of both a SERM and an estrogen hormone.

### Claim 11 (depends on 1)

The method of claim 1, wherein said pharmaceutical composition is an ointment, a lotion, an emulsion, an aqueous solution, or a non-aqueous solution.

### Claim 12

A method for treating a female sexual disorder (FSD) comprising applying a pharmaceutical composition comprising a catechin between about 1% and 10% weight per weight of total composition to a vulva, a vaginal introitus or a vagina of a female patient, wherein said FSD is selected from the group consisting of genitopelvic pain disorder, vulvovaginal atrophy (VVA), vestibulodynia, dyspareunia, sexual arousal disorder (SIAD), and female orgasmic disorder (FOD).

### Claim 13 (depends on 12)

The method of claim 12, wherein said catechin concentration is about 5%.

### Claim 14 (depends on 13)

The method of claim 13, wherein said catechin includes epigallocatechin gallate (EGCg).

### Claim 15 (depends on 12)

The method of claim 12 wherein said pharmaceutical composition is an ointment.

### Claim 16 (depends on 12)

The method of claim 12, wherein said pharmaceutical composition is a lotion.

### Claim 17 (depends on 12)

The method of claim 12, wherein a thickness of vaginal mucosa remains substantially unchanged during treatment.

### Claim 18 (depends on 12)

The method of claim 12, wherein a vaginal maturation index remains substantially unaltered during treatment.

### Claim 19

A method for treating a female sexual disorder (FSD), comprising topically applying a viscous pharmaceutical composition comprising a catechin between about 2% and 12% weight per weight of total composition to a vulva, a vaginal introitus or a vagina of a female patient wherein a vaginal maturation index of the patient remains substantially unaltered during treatment of the FSD.

### Claim 20 (depends on 19)

The method of claim 19, wherein a thickness of vaginal mucosa remains substantially unchanged during treatment.

### Claim 21 (depends on 19)

The method of claim 19, wherein said catechin comprises epigallocatechin.

### Claim 22 (depends on 19)

The method of claim 19, wherein said catechin comprises epigallocatechin gallate.

### Claim 23 (depends on 19)

The method of claim 19 wherein said pharmaceutical composition is an ointment.

### Claim 24 (depends on 19)

The method of claim 19, wherein said pharmaceutical composition is a lotion.

### Claim 25

A method for treating a female sexual disorder (FSD), comprising topically applying a viscous pharmaceutical composition comprising a catechin component between about 2% and 12% weight per weight of total composition and a non-catechin estrogen modulator to a vulva, a vaginal introitus or a vagina of a female patient, wherein said FSD is selected from the group consisting of genitopelvic pain disorder, vulvovaginal atrophy (VVA), vestibulodynia, dyspareunia, sexual interest arousal disorder (SIAD), and female orgasmic disorder (FOD).

### Claim 26 (depends on 25)

The method of claim 25, wherein said non-catechin estrogen modulator comprises a selective estrogen receptor modulator (SERM).

### Claim 27 (depends on 26)

The method of claim 26, wherein said SERM is ospemifene.

### Claim 28 (depends on 25)

The method of claim 25, wherein the non-catechin estrogen modulator comprises an estrogen hormone.

### Claim 29 (depends on 25)

The method of claim 25, wherein the non-catechin estrogen modulator comprises a combination of both a SERM and an estrogen hormone.
