Acknowledgements: The program (click the picture above) and this coverage would not have been possible without the outstanding contribution of the Boston University School of Medicine Office of Continuing Medical Education; we owe lots of thanks for them.

The research work done by Drs Irwin Goldstein and Jennifer Berman are integral to this course and to the entire field of female sexual dysfunction.

From the therapeutic point-of-view, female arousal is regarded to blood flow and smooth muscle relaxation, just as it is in a man. What the patient ultimately will perceive with regard to that, feelings of pleasure or increased sensation will remain to be seen.

Psychologic Therapies

Psychotherapy and sex therapy are state-of-the-art therapies for female sexual dysfunction.

The young, healthy women with no clear organic base for their sexual dysfunction may benefit most from a sex therapy evaluation. A lot of times, women do not feel comfortable with their bodies or with expressing their needs to their partners. So in young, healthy women, these issues need to be addressed.

One has to note, though that there is a risk that the approaches to FSD therapies will be superficial if there is no thorough understanding of female sexual physiology and the types of pathology that can cause FSD.

Endocrine Therapy Using Estrogens and Androgens

Treatments for FSD additionally include hormone replacement therapy in menopausal women, topical creams, lubricants and drug therapies that increase blood flow to the genital area and relax muscles.

A variety of hormones has been tried. But, hormone levels do not clearly correlate with female sexual function or dysfunction.

Vasoactive Drugs: Rationale and Future

There are currently no drugs approved for the treatment of female sexual dysfunction. Any products proven to be safe and efficacious for treating FSD will enjoy a unique advantage.

Viagra may work just as well in women as in men to treat sexual problems, and it might be approved for use in females in two to five years, it was said in the meeting.

Dr. Jennifer Berman, one of the course directors, recently completed the first US clinical trials of Viagra on women at the University of Maryland Medical Center.

Thirteen women age 32 to 65 were given the drug and a placebo. The study found that Viagra appears to work the same way in women as in men. The drug increases blood flow to the genital area.

In Berman's study, Viagra appeared to enhance blood flow to the genitals, cause more lubrication during sex, more sensation, an enhancement of engorgement of the genitalia, and allow women to have an orgasm more easily.

Berman said the study vindicates women who were told they were having emotional problems.

Dr. Berman hopes to enroll more than 100 women in a Viagra study to start in Boston within the next six months. That study also aims to test other drugs that affect blood flow, including Apomorphine, which is still not on the market but which has been shown to cause spontaneous erections in men.

Women have similar side effects from Viagra as men, including facial flushing, nasal congestion and nausea.

It is recommended that this time women should not take Viagra outside of clinical trial settings where they can be observed and side effects monitored. The long term effects on fertility or on the unborn fetus are not known. So women of childbearing potential should not take this medication under any circumstance.

Vasoactive Drugs: Oral/Sublingual

The orally administered, lyophilized liposomal delivery of Apomorphine, treatment product for female and male sexual dysfunction is contained in a capsule and is swallowed by the patient. This capsule is designed to pass through the stomach without degradation or uptake of the drug and into the small intestine whereby the Apomorphine is then gradually released. The manufacturer, Harvard Scientific, plans to license these products to pharmaceutical companies for worldwide distribution upon approval by the US Food and Drug Administration and/or other foreign regulatory agencies.

Another company being in development of an oral treatment, phentolamine mesylate, is Texas-based Zonagen Inc. They have filed for approval of the product both in the US and in Europe for male sexual dysfunction, but is studying the drug among women as well.

Vasoactive Drugs: Topical Agents

Harvard Scientific Corporation has developed a proprietary treatment, lyophilized liposomal Prostaglandin E-1 ("LLPGE1"); the results of toxicity studies were presented by Dr. Goldstein. The company intends to submit an application for IND to the FDA shortly.

Applied topically to the vaginal area, the product is gel-based and contains LLPGE1 as an active agent. Its purpose is to topically enhance the blood flow within the clitoral and vaginal tissue to stimulate nerve endings for increased sensitivity in the female sex organs. Harvard Scientific believes this should facilitate lubrication, thus enabling greater satisfaction and possibly sexual orgasm for the female. The company is moving forward as rapidly as possible with implementation of its protocols for gaining US regulatory approval.

Results from the animal toxicity studies showed no toxicity when LLPGE1 was administered to the vaginal area of the rabbits. There was no redness or irritation at any dose or with the gel itself when observed visually each day. Therefore, there was no gross toxicity in the LLPGE1 gel base used.

Harvard Scientific has also initiated dynamic magnetic resonance imaging (MRI) blood flow studies to prove efficacy prior to initiating its clinical studies in humans.

Drugs: Conclusion

There are at least a dozen different major pharmaceutical groups all of whom have either drugs in development or potential for developing drugs for female sexual dysfunction.

The conference New Perspectives in the Management of Female Sexual Dysfunction was a novel approach: it included urologists, gynaecologists, and other surgeons, as well as sex therapists and psychotherapists. This kind of meeting of the kinds really has not occurred until now.

And now: Now it is even here - in the Internet! Hopefully you have enjoyed these excerpts.

Please find more congress coverage HERE

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