Compositions and methods for treating female sexual arousal disorder using hydrophobic-calcitonin gene related peptide

a technology of hydrophobic calcium and calcitonin, which is applied in the direction of peptide/protein ingredients, antibacterial agents, drug compositions, etc., can solve the problems of clitoral intracavernous, discomfort or even pain, and female sexual dysfunction

Inactive Publication Date: 2005-10-27
SOUTHARD JEFFREY L +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If a woman's sexual concerns are recurring in nature and cause her personal distress, she may indeed have female sexual dysfunction.
Reduced sexual arousal may result in discomfort or even pain due to insufficient vaginal lubrication and/or a lack of physical preparation of the genitalia for sexual activity.
Pelvic nerve stimulation results in clitoral smooth muscle relaxation in an increase in clitoral cavernosal artery inflow and an increase in clitoral intracavernous pressure, which lead to tumescence and extrusion of the glans clitoris.
Reduced levels of estrogen during and after menopause also contributes to arousal difficulties as well.
Reduced clitoral arterial flow may lead to fibrosis of the clitoral cavernosa and reduced clitoral physiological function.
Certain medication can also interfere with arousal.
Antidepressants,

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0050] The hydrophobic-CGRP according to the present invention may be mixed with Aquaphore cream to result in a concentration of 2.5 nmol / dose (10.18 μg / dose. About 0.1 to 0.5 ml of the hydrophobic-CGRP cream would then be applied on the surface of the clitoris with gentle rubbing. This local application of hydrophobic-CGRP containing cream can be repeated as necessary.

example 2

Topical Application of Hydrophobic CGRP to Decrease Refractory Time in Healthy Male Volunteers

[0051] This was an unofficial study conducted by the inventors to demonstrate proof of concept in humans for the invention. The study designed was a single blind, placebo controlled, single-dose, single and multiple application study to evaluate the safety and efficacy of CGRP-linolenic acid conjugate (hydrophobic-CGRP) applied topically to induce erections in six healthy male volunteers. Formulation A consisted of hydrophobic-CGRP mixed with Aquaphore cream (petroleum jelly / water emulsion) to a concentration of 10.18 μg / mL, formulation B, the placebo, was the Aquaphore vehicle. Six subjects received both formulation A and formulation B, and were instructed to apply each formulation on successive days (i.e. formulation A on one day, and formulation B the next day), and to do this on 3 separate occasions (n=18 applications). For each application, the subjects applied 0.5-1.0 mL of the cream...

example 3

[0053] Below are numerous exemplary preparations of the present invention as a weight to weight ratio. CGRP, CGRP analogues, and polypeptides containing the active site of CGRP can be substituted for hydrophobic-CGRP.

[0054] 1. 0.001% hydrophobic-CGRP, 99.999% vitamin E.

[0055] 2. 0.001% hydrophobic-CGRP, 99.999% cocoa butter.

[0056] 3. 0.001% hydrophobic-CGRP, 99.999% glycerine.

[0057] 4. 0.001% hydrophobic-CGRP, 99.999% carboxymethylcellulose.

[0058] 5. 0.001% hydrophobic-CGRP, 99.999% hydroxymethylcellulose.

[0059] 6. 0.001% hydrophobic-CGRP, 99.999% methylparaben.

[0060] 7. 0.001% hydrophobic-CGRP, 99.999% propylene glycol.

[0061] 8. 0.001% hydrophobic-CGRP, 99.999% polyethylene glycol.

[0062] 9. 0.001% hydrophobic-CGRP, ≧9.999% vitamin E, ≦90% cocoa butter and / or DI water and / or polyglycerylmethacrylate and / or glycerine and / or carboxymethylcellulose and / or hydroxymethylcellulose and / or methylparaben and / or propylene glycol and / or polyethylene glycol and / or sodium benzoate.

[006...

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Abstract

The present invention provides a method and composition for the treatment of Female Sexual Arousal Disorder. Calcitonin gene-related peptide, a naturally occurring substance in the human body, is chemically conjugated to a hydrophobic agent thereby increasing its permeability across the skin membrane. When locally applied to female genitalia localized blood flow is promoted thus resulting in increased sexual arousal.

Description

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to compositions and methods for the local administration of a therapeutic preparation for treating female sexual arousal dysfunction, and more particularly, to a preparation comprising calcitonin gene-related peptide conjugated to a hydrophobic agent and methods of use for promoting blood flow to the genital region, specifically the clitoris of a female patient. [0003] 2. Description of the State of Art [0004] According to the Journal of the American Medical Association, more than 43% of American women (about 40 million) experience some form of sexual disorder. Other reports state that 70% of post-menopausal and 25% of pre-menopausal women experience sexual dysfunction. Any woman can experience Female Sexual Dysfunction at some point in her life. Physicians and other healthcare providers recognize Female Sexual Dysfunction as a medical condition. It includes a variety of disorders that ...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K36/28A61K36/54A61K38/23
CPCA61K38/23A61K9/0034
Inventor SOUTHARD, JEFFREY L.YEWEY, GERALD L.ROSENTHAL, GARY J.
Owner SOUTHARD JEFFREY L
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