By: Red Hot Mamas
Published: May 26, 2010
A brief discussion of menopausal and postmenopausal sexuality
Some women may see the recent Food and Drug Administration’s (FDA) disapproval of Intrinsa (the first drug to enhance women’s sex drives) as unfair and one-sided. While the highly publicized Viagra precedent has been well established for over six years, women who face similar sexuality problems are still waiting for a safe drug to hit the market. The pharmaceutical company Proctor & Gamble’s objective is to develop a reliable drug for the following proposed indication:
“Treatment of hypoactive sexual desire disorder in surgically menopausal women receiving concomitant estrogen therapy. Hypoactive sexual desire disorder (HSDD) is the persistent or recurrent deficiency or absence of sexual thoughts, fantasies, and/or desire for or receptivity for sexual activity, which causes personal distress or interpersonal difficulties. Low sexual desire may be associated with low sexual activity, sexual arousal problems or orgasm difficulty.” -FDA Intrinsa Advisory Committee Background Document Overview; December 2, 2004
In other words, Proctor & Gamble’s clinical study was designed for women who experience low sexual drives (as defined above) due to surgically induced menopause (hysterectomies and oopherectomies). The pharmaceutical company focused their efforts toward investigating a hormonal drug to treat the common problem of female sexual dysfunction (FSD). Proctor & Gamble’s answer to the problem is Intrinsa. The treatment is a testosterone skin patch that can help revive women’s sex drive. The patch delivers testosterone to the blood stream at a gradual, continuous rate so a steady level is maintained. The patch is transparent and is worn discreetly on the abdomen. Testosterone is often considered the “male” hormone although women’s ovaries also produce testosterone. Testosterone levels drop to the low normal range or below normal when a woman reaches menopause, or has menopause surgically induced. Many researchers believe this drop may cause or at least contribute to a lack of interest in sex. By replacing testosterone levels back to normal, women may be able to recharge a stalled sex drive. Other potential benefits include increased clitoral sensitivity, vaginal lubrication, libido and sexual desire. For some women, Intrinsa sounds like the quintessential solution to sexuality issues.
In a recent letter to the FDA committee, Red Hot Mamas president and founder, Karen Giblin highlighted the importance of acknowledging sexuality issues with surgically induced menopausal women:
…Consider the fact that hysterectomy is the second most common major surgery among women in the United States with more than 600,000 hysterectomies performed each year. In addition, about a third of women in the United States have had a hysterectomy by age 60. In a survey of more than 600 hysterectomy patients by the HERS Foundation (Hysterectomy Educational Resources and Services), nearly 75 percent cited a loss of sexual desire they did not anticipate, while more than half experienced loss of sensuality and sexuality.
Because surgically menopausal women face more years of lower hormone levels than those undergoing a natural menopause, they are more likely to suffer with more conditions and/or symptoms linked to hormone deficiency, like loss of sexual desire. As a result, these women deserve safe and effective options that could improve their sexual functioning by boosting sexual desire and responsiveness…
…On behalf of myself and the thousands of PRIME PLUS/Red Hot Mamas®, I respectfully request that you give serious consideration to this opportunity to approve and make available a safe and effective option to treat loss of sexual desire. The FDA should not deny women treatment options that could provide significant enhancement to many lives.
In Proctor and Gamble’s most recent clinical study, 533 women with HSDD participated in a 24-week trial. The trial compared the effects of using a testosterone patch containing 300 micrograms (a low dose) of testosterone against a placebo patch. The study involved women ages 31 to 56 who had their ovaries and uteruses removed for medical reasons (i.e., fibroids or persistent bleeding). The women were also taking estrogen therapy. The patches were worn on the skin and changed twice a week during the study. The women completed sex diaries at the end of each rotation, evaluating their levels of desire, arousal, activity and pleasure. The results revealed significant improvements for women with the disorder including increased sexual arousal, orgasm, pleasure, responsiveness, and self-image. Women taking Intrinsa for six months reported that they experienced an average of one additional episode of intercourse, masturbation or oral sex every four weeks compared with women giving an inactive patch. These are generally positive results thus far.
On December 3, 2004, the FDA’s Advisory Committee disapproved Intrinsa due to the lack of safety information provided by Proctor & Gamble’s clinical study. The pharmaceutical company will revisit the clinical investigation to further assess possible side effects to the drug. Critics worry that the testosterone patch could have negative long-term side effects including the increased risk for breast cancer. Other side effects include acne, hair growth and deepened voices. Other concerns that were presented by the review panel on December 3rd included heart attack and stroke risks associated with the patch. Panel member Dr. Steven Nissen, a Cleveland Clinic Foundation cardiologist says “Proctor & Gamble needs to study at least 5,000 women for several years to see if the testosterone patch unacceptably raises cardiovascular risk.” At least some testosterone is metabolized to estrogen in the body. Another federal adviser, Dr. Charles Lockwood, a Yale University School of Medicine expert in maternal fetal medicine, wanted more information and data on the risk of development of clots in blood vessels and if there are differences with Intrinsa. Many see the advancement of the FDA and the pharmaceutical industry’s involvement in women’s health issues as limited and slow. Underlying political, sociological and economic issues are some people’s argument for the sluggish response to drugs such as Intrinsa. Perhaps we should not be so quick to judge society for the lack of drug availability for women’s health care. We must remember the intentions of the FDA and pharmaceutical companies are in our best interests. If additional safety is a concern, more research is needed. Remember how the Women’s Health Initiative affected our views on hormone replacement therapy.
In the meantime, women with menopausal and postmenopausal sexuality issues should assess their conditions and possible treatments for the disorder (provided by a doctor). While this brief article mainly discusses female sexual dysfunction as a physical disorder, it can be considered a psychological disorder as well. The psychological aspect of the problem can include emotional difficulties such as untreated anxiety, depression or stress, a history of or ongoing sexual abuse, body image, roles, power, a woman’s view of her partner or a conflicting cultural message. Usually, the biological (physical) components and psychological components interact and the root of the problem is not necessarily due to a single factor. For women, sexual response is complex and involves a mind-body connection. If you’re experiencing difficulties, seek the help of a doctor. If your testosterone level is low, other forms of testosterone are available. For further information on sex and menopause, refer to the July issue of the Menopause Minute newsletter article entitled: Sex and Menopause – What’s Menopause Got To Do With It?