| IN
SEARCH OF THE FEMALE VIAGRA
Stanley Ducharme, Ph.D.
Many people thought that December 2, 2004 might be a
historic day! On this date, the Food and Drug Administration
considered approval of the first pharmaceutical treatment
for women's sexual health.
Within a few hours of their deliberations however, the FDA rejected the application for the testosterone patch, Intrinsa. Citing the need for additional testing and concerns about long-term safety, the FDA requested a least a year of additional studies. Even then, Intrinsa's fate is uncertain.
Intrinsa, a testosterone patch that is placed on the woman's abdomen is currently under development by Procter and Gamble for the treatment of female low sexual desire. This is the first of about 10 new pharmaceutical products currently being studied for the treatment of female sexual dysfunction, (FSD). Similar to what Viagra did for men, this medication may ultimately have the potential to revolutionize the treatment of women's sexual difficulties. The development of Intrinsa and its future arrival however does not go without controversy.
Low
sexual desire is defined as "a decreased interest in
sexual activities and a lack of sexual fantasies." As a
result, women with low sexual desire often have difficulties
with sexual arousal and may find intercourse to be uncomfortable
or even painful. These women either stop all sexual contact
with their partner or are sexually active because of a sense
of obligation or guilt.
Typically, a woman's lack of sexual interest causes her a great deal of distress and anguish. Often, her marriage or relationship is under severe stress because of the lack of intimacy. Partners often feel rejected and unwanted.
Some studies done in the late 1990's have estimated that up to 43% of women suffer from various forms of sexual dysfunction. Of all sexual difficulties, low sexual desire is the most common for women of all ages.
Opinions
Differ
In reality, few scientists can agree as to the exact number of women who have sexual difficulties. Early studies of this issue have been criticized because of the involvement of pharmaceutical companies in the studies. Some researchers in these studies have been accused of having a conflict of interest. Researchers who work for drug companies obviously have a bias and an investment in the outcome of these epidemiological studies.
Many social scientists, especially women who are involved in sociological and feminist studies, believe that the actual number of women with low sexual desire is relatively low. They would argue that female sexual difficulties are normal at different times in the life cycle.
Furthermore,
some people believe that the drug companies tend to create
medical problems so that they can market and sell cures!
In the case of the sexually related medications, many critics
believe that drug companies are defining middle age
as a medical condition that needs to be treated with medication.
In addition, according to many people, it is a mistake to compare a woman's sexual response to a man's sexual performance. They argue that a man's functioning is determined by physical functioning but a woman's response is determined by multiple factors - emotions, relationships, trust, comfort, religion, stress, culture, age and safety are critical issues. Therefore, hormones, medications or a pill cannot produce a satisfying and gratifying sexual experience.
To the contrary, medical researchers believe that hormones or androgens such as testosterone are the critical factors behind a woman's sexual interest. They argue that certain medications such as birth control pills or anti-depressant medications interfere with the development of normal testosterone and that women with low interest have lower testosterone levels. In addition, hysterectomy, breast cancer, childbirth and menopause all contribute to the depletion of a woman's testosterone level. To treat low sexual desire, physicians currently give women low levels of testosterone. Since this is an "off label" use of these medications, they are not covered by insurance.
Initially, Procter and Gamble are seeking FDA approval for the use of testosterone patches on only a small number of women - those who have had their ovaries removed and are taking estrogen. However, many people are concerned that this will simply be the first step in a much wider use of the patch.
Potential
"off label" uses of the patch might include women of all
ages who are experiencing low sexual desire because
of other medical and psychiatric conditions. Noting how
the male pill Viagra is often used for "recreational purposes",
the FDA is taking no chances that Intrinsa will also be
misused.
SCI
Data Missing
What does all of this mean for women with spinal cord injury (SCI)? To date, no studies, to my knowledge, have tried to determine the extent of low sexual desire for women with SCI. Furthermore; none of the tests done so far with Intrinsa have included women with SCI. As is often the case, such studies with specific populations tend to be conducted after the Phase 2 clinical trials have been completed. For example, when Levitra and Cialis were being tested with men, no SCI studies in the initial testing phases of the drugs.
What does all of this mean for women with spinal cord injury (SCI)? To date, no studies, to my knowledge, have tried to determine the extent of low sexual desire for women with SCI. Furthermore; none of the tests done so far with Intrinsa have included women with SCI. As is often the case, such studies with specific populations tend to be conducted after the Phase 2 clinical trials have been completed. For example, when Levitra and Cialis were being tested with men, no SCI studies in the initial testing phases of the drugs.
Typically, women with SCI often experience lack of sensation, difficulty with orgasm and poor arousal and lubrication. Lack of desire is also not uncommon for women with SCI. It is often associated with various medications given to many women with SCI. These may include medications for depression, spasticity or birth control pills. In addition, depression and changes in body image can have a negative effect on a woman's interest in resuming sexual activity after an injury.
The
Quest Continues
As I have mentioned, at this time there are no effective, FDA approved medications to improve sexual desire for women. Although some doctors may be using "off label" medications to improve libido, many women are rightly concerned about side effects such as facial hair, acne, possible liver damage and the potential for breast cancer. Long term outcomes have also not been studied since these treatments have only been in use over the last several years.
As Procter and Gamble continue to seek FDA approval for Intrinsa, we should be learning more as to the safety of testosterone treatment for women.
Contact:
Readers may send questions anonymously to Dr. Ducharme via
the contact page of this web site.
Back
to Articles |
