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June 30, 2015 at 11:19 AMComments: 0 Faves: 0

The "Female Viagra" - What Does it Do and How Well Does it Really Work?

By Jeffrey VanWingen M.D. More Blogs by This Author

Viagra, a medical "Holy Grail" for men with problems in the sexual arena was approved by the FDA over 18 years ago. Since that time speculation has waxed and waned about a female pharmaceutical for women to help with sexual dysfunction. New light has recently been shed on this question.

It's not Viagra

First off, the branding of Viagra needs to be dispatched. It's a bit like Kleenex. Something that is revolutionary and first to the marketplace becomes a defining term, broader than the brand.  It seems that Viagra has become a descriptor for any sexual enhancement in a pill. In truth, however, Viagra is a pharmaceutical with the very specific function of enhancing erections.  Sparing a lot of the science and chemical pathways, Viagra inhibits an enzyme that inhibits an activator in the process of bringing on and maintaining erections.  In short, Viagra helps solely with the process of erectile function in males. It does nothing for libido in men and it does nothing for libido in women.

The Female Problem

Pharmaceutical research and development has focused on low libido (sexual desire) as the top female problem in the sexual arena. For women, this problem of low libido is more psychological than mechanical function. The official name for this problem is Hypoactive Sexual Desire Disorder, or HSDD.

DSM-IV criteria for HSDD diagnosis requires that all three of the following is true:

A. Persistently or recurrently deficient (or absent) sexual fantasies and desire for sexual activity. The judgement of deficiency or absence is made by the clinician, taking into account factors that affect sexual functioning, such as age and the context of the person's life.

B. The disturbance causes marked distress or interpersonal difficulty.

C. The sexual dysfunction is not better accounted for by another Axis I disorder (except another Sexual Dysfunction) and is not due exclusively to the direst physiological effects of a substance (e.g., a drug of abuse or a medication) or a general medical condition.

It is estimated that seven percent of women have this problem in their pre-menopausal years. The numbers are likely higher in post menopausal years.

The race to develop a pharmaceutical for HSDD seems to have a drug called flibanserin manufactured by Sprout Pharmaceuticals. After being sent back to the drawing board twice by the FDA, their third showing seems to show promise. This month, the FDA advisory committees reviewing the drug voted to support its approval. While it looks promising that it will be approved, cautions were expressed that benefits seem to be modest and that safety concerns exist. While the drug would be approved for use in pre-menopausal women (not yet in menopause), it is recognized that many prescribing healthcare providers will likely go beyond these guidelines for use.

How Flibanserin Works

The drug works to modulate the balance of serotonin and dopamine which in turn can yield effects on sex hormones and the sexual response. In research studies, the drug was studied against placebo, utilizing a few different scales to gauge sexual interest and pleasure.

When the results were in, flibanserin showed a 1/2 to 2 events per month additional satisfying sexual events over placebo/baseline. In addition there were improvements on the Female Sexual Function Index (test can be found here) . Specifically, on a scale of 1.2 to 6.0, flibanserin came in at a 0.3 to 0.4 improvement. There were also modest improvements of 0.3 to 0.4 on the 4 point Female Sexual Distress Scale (test can be found here) compared to placebo.

While this data can be a bit ambiguous, it did meet the benchmark of statistical significance. In other words, the improvements are scientifically due to the medicine and not change when compared to placebo. It should be noted, however, that there was a very large placebo effect with this medication. While 51% of women taking the drug noted improvements, 38% of women taking the placebo also noted improvements.

The most common side effects include:

  • Nausea
  • Insomnia
  • Upset Stomach
  • Dizziness
  • Fatigue
  • Dry Mouth
  • Anxiety

Potential harmful effects of the medication were noted when mixed with alcohol. Further, other medications (such as antidepressants which are notorious for the deleterious effects on sex drive), when taken with flibanserin yielded harmful side-effects.

Bottom Line?

It appears that a new pharmaceutical for female low libido, or Hypoactive Sexual Desire Disorder, is on the horizon. While the effects of this drug may be modest it may offer help to women suffering with the problem. There was a large placebo effect in the studies on the drug but this in itself may offer some benefit. Cautions will be issued for alcohol use with the medication in addition to certain other prescription drugs. It is not known at this time when the drug will come up for final FDA approval, but preliminary review is favorable with support from the reviewing committees.

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