Monday, November 16, 2009

Medication for Women with Hypoactive Sexual Desire

"Women simply shouldn't have to live with a distressing lack of sexual desire," asserts Anita Clayton, MD, professor of psychiatry and neurobehavioral sciences at the University of Virginia School of Medicine. "But right now women don't have many treatment options."

That soon may change for the thousands - perhaps millions - of pre-menopausal women suffering from Hypoactive Sexual Desire Disorder (HSDD), an under-treated medical condition often described by women as a distressing lack of, or decrease in, sexual desire that may put strain on relationships with their partners.

Dr. Clayton and fellow lead investigators have announced remarkable results from several nationwide Phase III clinical trials assessing flibanserin, a new non-hormonal medication that is proving to be an effective therapy for pre-menopausal women with HSDD. Findings were presented November 15, 2009 at the 12th Congress of the European Society for Sexual Medicine in Lyon, France.

Trial data demonstrates that flibanserin 100mg daily increased the number of satisfying sexual events (SSE) and sexual desire (the study's co-primary endpoints) while decreasing the distress associated with HSDD. Flibanserin is an investigational compound being developed by Boehringer Ingelheim Pharmaceuticals, Inc.

"With this data, we are making exciting progress in women's sexual health research, as flibanserin is the first in a class of drugs being studied for this condition in pre-menopausal women," says Dr. Clayton. "This is an important milestone for an under-recognized condition for which there is no FDA-approved treatment."

"HSDD is a complex condition that can cause distress and negatively impact a woman's self-esteem," Dr. Clayton continues. "Women suffering from this disorder often report feelings of frustration and anxiety and view themselves as being sexually defective. They worry about their lack of desire negatively affecting their relationship and their partner. But I think it's important to note that we're not talking about women who simply don't want to have sex or aren't concerned about a lack of desire. It's about the women who suffer significant mental distress from their lack of desire."

In the pooled analysis of 1,378 pre-menopausal women with HSDD, the frequency of satisfying sexual events (SSE) increased significantly in women taking flibanserin 100mg (increasing from 2.8 at baseline to 4.5 at study end) versus placebo (2.7 at baseline increasing to 3.7 at study end) over the 24-week study period. A patient reported outcome measure, SSE measures the number of sexual events (defined as sexual intercourse, oral sex, masturbation or genital stimulation by the partner), and whether each event was satisfying for the woman.

Flibanserin also demonstrated statistically significant improvements in sexual desire versus placebo as measured by a daily electronic diary (eDiary) and the Female Sexual Function Index (FSFI) desire domain. The FSFI is a 19-item self-administered questionnaire composed of six domains (desire, arousal, lubrication, orgasm, satisfaction and pain).

Flibanserin significantly improved sexual functioning (as measured by the FSFI total score), distress related to sexual dysfunction (as measured by a self-administered questionnaire, the Female Sexual Distress Scale-Revised, FSDS-R, score) and distress related to low sexual desire (the score on FSDS-R question 13) versus placebo.

All women enrolled in the study were in stable, communicative, monogamous, heterosexual relationships with a sexually functioning partner for at least one year. Women ranged in age from 18 to 55 and were required to use a reliable form of contraception.

"HSDD is not a new disorder; it's been recognized in the field for more than 30 years," Dr. Clayton points out. "What's new is that people are beginning to talk about it. Before, women's sexual issues were taboo subjects - even between patient and physician. Now we have the chance to open up the dialogue."

Monday, November 9, 2009

Using lubricants during sex

An Indiana University study involving 2,453 women ages 18 to 68 found that lubricant use during sexual activity alone or with a partner contributed to higher ratings of pleasurable and satisfying sex.

Personal lubricants have long been recommended to women to improve the comfort of sexual intercourse and to reduce the risk of vaginal tearing, yet strikingly little available data is available on women's use of lubricants or associated vaginal symptoms.

The study, conducted by Debby Herbenick, associate director of the Center for Sexual Health Promotion at IU's School of Health, Physical Education and Recreation, involved women who used one of six different water- or silicone-based lubricants.

The study also found that side effects were rarely associated with lubricant use; vaginal tearing occurred during less than 1 percent of vaginal intercourse events and genital pain was reported in less than 5 percent of intercourse acts when lubricant was used.

Herbenick will present her findings at on Monday, Nov. 9, at 3:10 p.m. during the "What's Sex Got To Do With It?" session. Co-authors are Devon J. Hensel , IU School of Medicine; Kristen Jozkowski, Center for Sexual Health Promotion; Michael Reece, CSHP; and J. Dennis Fortenberry, IU School of Medicine.

Researchers from the Center of Sexual Health Promotion conducted more than 15 studies being presented at the APHA conference. Public health professionals routinely recommend the addition of lubricant to condoms during sexual activity, yet virtually no research has assessed the sexual situations during which the recommendations are followed. The following two CSHP studies help fill in the gaps.

A CSHP study involving 2,453 women examined their use of water-based or silicone-based lubricants during sexual activity. The use of lubricants during sexual activity has been recommended as a strategy to reduce the likelihood of vaginal tearing, which can increase risk for HIV and other STI. The study participants strongly endorsed the notion that lubricant use improved the sexual experience; in more than 70 percent of events, women indicated that using lubricants made sex feel very pleasurable and more comfortable (65.5 percent). The women in the study primarily were heterosexual (85.6 percent) and married (56.4 percent), with an average age of 32.5. Other findings: When applying lubricant, 58.4 percent of events involved application to the woman's genitals by their sexual partner, 54.7 percent involved women applying lubricant to their own or their partner's fingers, and 53.4 percent involved women applying lubricant directly on their partner's genitals. Most frequently reported reasons for lubricant use included the desire to reduce the risk of tearing (22 percent) and to make sex more comfortable (21.8 percent). Co-authors include lead author Jozkowski, Herbenick, Hensel, Reece and Fortenberry. The research was supported by The Patty Brisben Foundation. Jozkowski will present the findings on Monday, Nov. 9, at 2:30 p.m. during the "Women and HIV: Emerging Issues" session.

A CSHP study involving 1,834 men examined the use of lubricants during vaginal intercourse. The study involved 8,876 coital events, 46.8 percent of which involved the use of a latex condom and 24.7 percent of which involved the use of a lubricant. Additional results: most frequently, lubricant was added to the external tip of the condom after penile application (22.5 percent), directly in or around the partner's vagina (16.2 percent), and to both the condom and vagina (16.2 percent). The addition of lubricant to condoms was more likely during intercourse with a spouse than with a non-committed partner, during intercourse events of longer duration, when a female partner applied the condom to the partner's penis, and when a female partner used Nuva Ring, IUD or spermicidal jelly/foam as a method of contraception. The research was supported by The Patty Brisben Foundation. Co-authors include, Reece, Hensel, Herbenick, Fortenberry, and Brian Dodge, CSHP. Reece will present the findings on Monday, Nov. 9, at 10:30 a.m. during the "Innovative Research on Sexual Health" session.