According to a recent study of over 30,000 women in the U.S. published in the journal Obstetrics and Gynecology, over 40% of women report having some sort of sexual dysfunction, and 12% reported distress and that these problems affected their daily lives.

“These statistics are consistent with other reports of prevalence,” says Dr. Sheryl A. Kingsberg, clinical psychologist, author, and associate professor. “More than 40% of women have one or more sexual problems and more that 10% of these women are significantly distressed by their sexual problems.” The most prevalent sexual problem for women of all ages is hypoactive sexual desire disorder (HSDD). Experts in sexual medicine consider a sexual problem to be a disorder only when it causes distress in the individual or causes interpersonal difficulties. Dr. Kingsberg believes physicians are not initiating discussions about sexual concerns with patients due to shorter patient visits, lack of training in sexual medicine, and the lack of an FDA-approved Rx treatment for female sexual disorders.

In the Massachusetts General Hospital study, 39% of women eighteen and older reported low levels of desire, 26% had problems with arousal, and 21% had difficulties with orgasm. Women older than sixty-five had the highest levels of sexual problems, but they also reported the least amount of distress about the issue.

Incidence of Hypoactive Sexual Desire Disorder (HSDD), the most common sexual problem for women increases with age and after certain surgical procedures, particularly removal of the ovaries, and can arise from many causes, including relationship problems, the use of prescription pharmaceuticals, chronic diseases, or chemical imbalances in the brain.

Although testosterone is popularly thought of as a male hormone, it also is present in women and is important for sexual health, particularly sexual desire. Postmenopausal women with HSDD have been treated with off-label or compounded testosterone for many years, although the hormone has not been approved specifically for that use in the U.S. Researchers believe that testosterone levels, which fall with increasing age, may contribute to a woman’s sexual desire.

A woman in her fifties has about half the level of blood testosterone than a woman in her twenties. “A significant drop in sex drive can lead to distress for both parties in the relationship,” says Dr. Kingsberg. “It can also jumpstart discussions to address the problem. It may be a problem to some women and not one to others, but the bottom line is discussions need to be made with doctors because it is an issue where larger health problems can stem from.”

“More awareness is being made in the medical community to identify significant changes in sexual desire in post-menopause patients and guide women to doctors specializing in sexual health and or/counseling,” explains Dr. Kingsberg. “Online resources also are available such as arhp.org and the National Women’s Health Network. While there is no FDA approved treatment, progress is being made.”

The lead product in development for treating FSD in postmenopausal women is LibiGel® by BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX). Currently, BioSante is conducting three Phase III clinical trials to demonstrate the safety and efficacy of LibiGel, including increasing sexual desire and sexual activity.

When safety and efficacy studies are completed and if the FDA approves the drug, LibiGel® may become the first FDA-approved treatment specifically indicated for HSDD in postmenopausal women. BioSante hopes to get FDA approval some time during 2010 or 2011.

Topics for discussion include:
• What are some of the implications of the Massachusetts General Hospital study?
• What are some tips for partners beginning discussions with their wives or girlfriends about female sexual dysfunction?
• How might physicians better initiate discussions about female sexual dysfunction with post-menopausal patients?
• What are some of the causes of female sexual dysfunction in post-menopausal women?
• What are some of the negative effects of a sudden drop in female sexual desire?
• How does testosterone, popularly thought of as a male hormone, influence female sexual desire?
• How does BioSante’s LibiGel ® address Hypoactive Sexual Desire Disorder and when might it be available to post-menopausal patients?

About Sheryl A. Kingsberg, PhD
Dr. Kingsberg is a clinical psychologist and associate professor in the Departments of Reproductive Biology and Psychiatry at Case Western Reserve University School of Medicine. She is also the chief of the Division of Behavioral Medicine in the Department of Obstetrics/Gynecology at MacDonald Women’s Hospital.

Dr. Kingsberg is the President-Elect of The International Society for the Study of Women’s Sexual Health (ISSWSH). She has authored numerous peer-reviewed manuscripts as well as several book chapters on topics including menopause and sexuality, sexual aversion disorder, the treatment of psychogenic erectile dysfunction, oocyte donation, and infertility. She sits on the editorial boards for the journals Menopause and the International Journal of Impotence Research. Her main research interests are in sexual medicine and the psychological aspects of infertility and menopause.

Dr. Kingsberg discloses that she has been a clinical investigator for Boehringer Ingelheim, BioSante, and Procter and Gamble and has been a consultant for Boehringer Ingelheim, Wyeth, Johnson & Johnson, and Procter and Gamble.

About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. BioSante’s lead products include LibiGel® (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin™ (estradiol gel) developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S. Also in development are Bio-T-Gel™, a testosterone gel for male hypogonadism, and an oral contraceptive in Phase II clinical development using BioSante patented technology. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3 billion. The company also is developing its calcium phosphate technology (CaP) for novel vaccines, drug delivery and aesthetic medicine (BioLook™).

Source: BioSante Pharmaceuticals