# US 10,500,166 B2 · Methods for the treatment of erectile dysfunction using fispemifene

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- Number: US 10,500,166 B2
- Document ID: US10500166B2
- Status: Granted
- Kind: B2
- Application number: 13/848,325
- Filed: 2013-03-21
- Published: 2013-08-22
- Granted: 2019-12-10
- Earliest claimed: 2007-06-13
- Assignees: Quatrx Pharmaceuticals Company
- Applicants: Robert L. Zerbe; Alexander Bridges; Risto Lammintausta; Rochelle Hanley; Stuart Dombey
- Inventors: Robert L. Zerbe; Alexander Bridges; Risto Lammintausta; Rochelle Hanley; Stuart Dombey
- Web page: https://patentgrep.com/patent/US10500166B2

## CPC

- A61K 31/085: having an ether linkage to aromatic ring nuclear carbon
- A61K 9/00: Medicinal preparations characterised by special physical form {(nuclear magnetic resonance contrast preparations or magnetic resonance imaging contrast preparations A61K49/18; preparations containing radioactive substances A61K51/12)}
- A61K 31/075: Ethers or acetals
- A61K 31/135: having aromatic rings {, e.g. ketamine, nortriptyline (methadone A61K31/137)}
- A61K 31/496: Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
- A61K 31/4985: Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 31/53: having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine (melarsoprol A61K31/555 {; with four nitrogen atoms A61K31/495})
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 15/10: for impotence
- 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

A method of treatment of erectile dysfunction (ED) comprises the step of administering fispemifene to a subject in need thereof in an amount effective to raise the subject's testosterone level. Fispemifene may be used in combination with a PDE-5 inhibitor in individuals who have failed to respond sufficiently to conventional ED treatment. Methods are also disclosed of treating ED by administering clomifene, enclomifene, ospemifene, toremifene and mixtures thereof in combination with a PDE-5 inhibitor.

## Claims

### Claim 1

A method of treating erectile dysfunction, comprising administering a therapeutically effective amount of fispemifene to a subject in need thereof, the subject further suffering from secondary hypogonadism and metabolic syndrome.

### Claim 2 (depends on 1)

The method of claim 1 wherein the subject has low serum total testosterone, in a range of less than about 400 ng/dL.

### Claim 3 (depends on 1)

The method of claim 1 wherein the subject is insufficiently responsive to treatment with a PDE-5 inhibitor alone.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the therapeutically effective amount of fispemifene is about 10 mg to about 1000 mg.

### Claim 5 (depends on 1)

The method of claim 1, further comprising administration of a therapeutically effective amount of a PDE-5 inhibitor.

### Claim 6 (depends on 5)

The method of claim 5, wherein the PDE-5 inhibitor is sildenafil, vardenafil, or tadalafil.

### Claim 7 (depends on 5)

The method of claim 5, wherein the PDE-5 inhibitor is tadalafil.

### Claim 8 (depends on 1)

The method of claim 1, wherein the therapeutically effective amount of fispemifene is an amount sufficient to raise levels of testosterone, luteinizing hormone, and follicle-stimulating hormone.

### Claim 9 (depends on 1)

The method of claim 1, wherein the therapeutically effective amount of fispemifene is about 10 mg to about 1000 mg administered orally.

### Claim 10 (depends on 7)

The method of claim 7, wherein the therapeutically effective amount of tadalafil is in the range of 2.5 mg to 20 mg administered orally.

### Claim 11 (depends on 3)

The method of claim 3, further comprising administration of a therapeutically effective amount of a PDE-5 inhibitor.

### Claim 12 (depends on 1)

The method of claim 1, wherein the erectile dysfunction is treated without harmful effects on fertility.