WO2000010559A1

WO2000010559A1 - Inorgasmia treatment

Info

Publication number: WO2000010559A1
Application number: PCT/GB1999/002791
Authority: WO
Inventors: Colin Anthony Kemp
Original assignee: FUTURA MEDICAL Ltd
Current assignee: FUTURA MEDICAL Ltd
Priority date: 1998-08-25
Filing date: 1999-08-24
Publication date: 2000-03-02
Anticipated expiration: 2001-02-25
Also published as: GB9818524D0; AU5524399A

Abstract

A composition and method for the treatment of female inorgasmia and for prevention of bacterial infection of the bladder during sexual intercourse involves the use of glyceryl trinitrate and lanolin in combination.

Description

INORGASMIA TREATMENT

This invention relates to a preparation for the treatment of female inorgasmia.

Female inorgasmia (or the failure of women to reach climax during sexual intercourse) is thought to be a common problem, but is not often diagnosed by the medical profession, except in certain specialised clinics. Several clinicians have theorised that this condition is due to an inadequate blood supply to the clitoris, especially during sexual excitation. Some research has established the importance of an adequate blood supply for achieving orgasms.

The clitoris, including the associated nerves and blood vessels, is an organ which until recently has not been studied in detail, it having been thought of as a relatively small mass of erectile tissue located close to the labia or lips of the vuiva. While it has hitherto been recognised as an organ capable of stimulation during sexual activity, more recent studies have revealed that the external ly-apparent tip or glans of the clitoris is connected internally to a larger mass of erectile tissue which itself has two arms which extend rearwardly into the body on either side of the urethra. The arms terminate in a bulb between the vagina and anus. During sexual activity, it is now thought not only that the nerves connected to the clitoris help in promoting sexual arousal but also that the body and arms of the clitoris, which in effect surround the urethra on three sides, the fourth being embedded in the front wall of the vagina, become distended and squeeze the urethra to a closed position, thus preventing bacteria from entering the bladder. It therefore appears that erection of the clitoris during sexual activity has an infection-preventing role as well as a pleasure-enhancing role and it is thus more important than hitherto realised for erection of the clitoris to occur both before and during sexual intercourse.

The object of this invention is to provided a preparation for direct application to the glans of the clitoris, prior to sexual activity, in order to promote erection or distension thereof.

According to one aspect of the invention there is provided the use of a combination of compounds in the preparation of a composition for application to the glans of the clitoris, the compounds comprising glyceryl trinitrate and lanolin. According to another aspect of the invention, a method of treatment of female inorgasmia comprises applying to the genital area a composition comprising an effective amount of glyceryl trinitrate and lanolin, and causing or permitting the composition to penetrate the skin or mucous membrane covering the glans of the clitoris.

According to yet another aspect of the invention, a method of prevention of bacterial infection of the bladder during sexual intercourse comprises applying to the genital area before intercourse a composition comprising an effective amount of glyceryl trinitrate and lanolin, and causing or permitting the composition to penetrate the skin or mucous membrane covering the glans of the clitoris.

The carrying out of the method of the invention before sexual intercourse results in an erection of the clitoris which may assist the female in reaching a climax and which may assist in prevention of bacterial infection of the bladder.

The invention also includes, in a further aspect, the use of glyceryl trinitrate and lanolin in the treatment of female inorgasmia or in prevention of bacterial infection of the bladder. The glyceryl trinitrate acts as a vasodilator according to its established utility for example in the treatment of angina pectoris but it has not hitherto been recognised that in simple combination with lanolin there could be provided an effective composition for promoting erection of the clitoris.

Glyceryl trinitrate is a material which is per se explosive. For use in the present invention, it is preferably absorbed on a solid stabiliser in finely-divided paniculate form, the particles being in the sub-micron size range to render them capable of passage through the skin. A preferred stabiliser compound is lactose on which the glyceryl trinitrate may be absorbed at a concentration of from 5 to 25% by weight, for example 10% by weight or 20% by weight.

The lanolin acts as a lubricant or moisturiser and also enhances skin absorption. It is known to be non-toxic and for the purpose of the present invention should be used as a medical grade such as "Medilan" (Trade Mark).

Preferably, compositions according to the invention also include a physical stabiliser such as a paraffin cream; optionally, the compositions contain other ingredients such as fragrances and/or colorants. The paraffin cream, for example provided as White Soft Paraffin B.P., promotes stability of the composition on the skin and also acts as a water-repellent barrier and lubricant.

The composition also includes water to adjust the overall viscosity or consistency and concentration of the active ingredient to the desired levels, bearing in mind that for ease of use the composition should be in the form of a physically-stable suspension of the active ingredient in a creamy emulsion which is sufficiently low in viscosity to be readily applied to and spread over the clitoris at ordinary body temperatures.

An example of a composition for use according to the present invention is given below:

Compositions for use in the invention may contain glyceryl trinitrate at a concentration of 0.5 to 2.5% by weight and may be supplied in unit dosage form, for example as tubes containing 2g of the composition.

Ingredient Weight %

Glyceryl trinitrate (20% in lactose) 10

Lanolin ("Medilan") 44

White Soft Paraffin B.P. 21

Demineralised Water 25

Another gel formulation according to the invention but containing nitroglycerine at a level of 0.75% by weight was tested on nineteen volunteer patents who had reported at least a 2 year period without orgasm, and all reported that this had had a detrimental effect on their sexual activity. The range was from 2.3 years to 7.5 years, without orgasm. The ages ranged from 26 to 52. All patients received a complete medical examination and none of the patients had any underlying cardiovascular disease, cancer, vaginal infections or a history of genito urinary disease. To begin, a quantity of the formulation was applied to the underside forearm of the patient to detect any sensitivity reaction; none of the patients appeared to show sensitivity. The patients were then placed in an examination room with complete privacy and wore only a hospital gown. Various sterile sexual stimulation products were provided, sexual videos and masturbation devices. The women were instructed to use the stimulation device of their choice. The patients were shown how to apply the formulation direct to their clitoris with massaging for 1 to 2 minutes. The patient was then left in complete privacy for one hour. An alarm mechanism was provided to the patient in case of any emergency. The patients were instructed to record their activity and sensation in a proper medical case form report book, at the end of the hour. 15 patients (79%) reported an orgasmic experience, 2 patients (1.5%) reported an increased sensation without orgasm, 2 patients (10.5%) reported no response from their normal experiences. None of the patients reported ∑my side effects. Blood pressure was measured immediately after the one hour and all were within the normal parameters, as measured the previous day. One patient in the increased sensation group did report a slight irritation to the clitoris, but upon medical evaluation there was no evidence of inflammation.

It is concluded that the formulation has a positive effect on women with female inorgasmia of long standing duration.

Claims

1. The use of a combination of compounds in the preparation of a composition for application to the glans of the clitoris, the compounds comprising glyceryl trinitrate and lanolin.

2. A method of treatment of female inorgasmia, the method comprising applying to the genital area a composition comprising an effective amount of glyceryl trinitrate and lanolin, and causing or permitting the composition to penetrate the skin or mucous membrane covering the glans of the clitoris, to produce an erection or distension thereof.

3. A method of prevention of bacterial infection of the bladder during sexual intercourse, the method comprising applying to the genital area before intercourse a composition comprising an effective amount of glyceryl trinitrate and lanolin, and causing or permitting the composition to penetrate the skin or mucous membrane covering the glans of the clitoris.

4. The use of glyceryl trinitrate and lanolin in the treatment of female inorgasmia.

5. The use of glycerly trinitrate and lanolin in the prevention of bacterial infection of the bladder.

6. The use according to any of claims 1, 4 and 5 or the method according to claim 2 or claim 3, in which the glyceryl trinitrate is absorbed on a solid stabiliser compound in finely-divided paniculate form.

7. The use or the method according to claim 6, in which the stabilizer compound comprises lactose.

8. The use or the method according to claim 7, in which the glyceryl trinitrate is absorbed on the lactose at a concentration of from 5 to 20% by weight.

9. The use or the method according to any preceding claim, in which the composition also includes a physical stabilizer.

10. The use or the method according to claim 9, in which the composition also includes water.

11. The use or the method according to any preceding claim, in which the composition contains glyceryl trinitrate at a concentration from 0.5 to 2.5% by weight.

12. The use or the method according to claim 11, in which the composition consists essentially of 44 wt% lanolin, 21 wt% white soft paraffin, 25 wt% demineralized water and 10 wt% lactose containing from 10 to 20 wt% glyceryl trinitrate.

13. The use or the method according to any preceding claim, in which the composition is supplied in unit dosage form.