# US 5,708,031 A · Prostaglandin E2 treatment of impotence

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- Number: US 5,708,031 A
- Document ID: US5708031A
- Status: Granted
- Kind: A
- Application number: 08/090,483
- Filed: 1993-07-12
- Granted: 1998-01-13
- Earliest claimed: 1991-07-03
- Inventors: Nathan E. Scott
- Web page: https://patentgrep.com/patent/US5708031A

## CPC

- A61K 31/5575: having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
- A61K 9/0034: {Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants}
- A61K 31/557: Eicosanoids, e.g. leukotrienes {or prostaglandins}
- 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)

## Abstract

Disclosed are compositions and methods for the treatment of male impotence, wherein erectile dysfunction is alleviated by administering a pharmaceutically acceptable formulation containing prostaglandin PGE.sub.2. An antidote for the effects of administration of the PGE.sub.2, or for treating priapism of other etiology, is also disclosed.

## Claims

### Claim 1

A method of treating erectile dysfunction in a male patient, comprising the step of administering to the urethra of the patient a unit dose of a formulation comprising an erectile dysfunction treating amount of a compound having the structural formula: ##STR3## or pharmaceutically acceptable salt or ester thereof, together with a pharmaceutically acceptable delivery medium.

### Claim 2 (depends on 1)

A method as in claim 1, wherein said administration step further comprises occluding the urethra distally of the formulation to prevent the escape thereof.

### Claim 3 (depends on 1)

A method as in claim 1, wherein said formulation further comprises an anesthetic agent.

### Claim 4 (depends on 3)

A method as in claim 3, wherein said anesthetic agent comprises lidocaine.

### Claim 5 (depends on 1)

A method as in claim 1, wherein said formulation further comprises a lubricating agent.

### Claim 6 (depends on 1)

A method as in claim 1, wherein said formulation is in the form of a cream or gel.

### Claim 7 (depends on 1)

A method as in claim 1, wherein said formulation is in the form of a suppository.

### Claim 8

An elongated drug delivery vehicle dimensioned for transurethral insertion, said delivery vehicle containing about 2 cc of a composition comprising an erectile dysfunction treating amount of prostaglandin E.sub.2 or pharmaceutically acceptable salt thereof and a delivery medium for the transurethral delivery of said formulation, the amount of prostaglandin E.sub.2 being less than about 5.0 mg.

### Claim 9 (depends on 8)

A formulation as in claim 8, further comprising an anesthetic agent.

### Claim 10 (depends on 8)

A formulation as in claim 8, further comprising a lubricant.

### Claim 11 (depends on 8)

A delivery vehicle as in claim 8, wherein the structural integrity of said vehicle is provided by a material which softens under the influence of body heat.

### Claim 12 (depends on 8)

A delivery vehicle as in claim 8, wherein the structural integrity of said vehicle is provided by a material which is dissolvable in an aqueous environment.

### Claim 13 (depends on 8)

A delivery vehicle as in claim 8, wherein said delivery vehicle comprises a time-release drug delivery medium.

### Claim 14 (depends on 1)

A method as in claim 1, wherein said unit dose comprises within the range of from about 10 mg to about 50 mg of said compound.

### Claim 15 (depends on 1)

A method as in claim 1, wherein said unit dose of formulation comprises within the range of from about 0.2 mg to about 3.6 mg of said compound.

### Claim 16 (depends on 2)

A method of reversing the erectile dysfunction treating effect of administration of the delivery vehicle of claim 2, comprising the step of administering to the urethra of a patient a unit dose of an antidote formulation comprising a compound having the structural formula: ##STR4## or pharmaceutically acceptable salt thereof, together with a pharmaceutically acceptable delivery medium.

### Claim 17 (depends on 16)

A method as in claim 16, wherein said unit dose comprises within the range of from about 5 .mu.g to about 50 .mu.g of said compound.

### Claim 18 (depends on 17)

A method as in claim 17, wherein said unit dose comprises from about 8 .mu.g to about 20 .mu.g of said compound.

### Claim 19 (depends on 16)

A method as in claim 16, wherein the administering step comprises transurethrally administering said antidote formulation.