Results of a recent drug trial suggest that premenopausal women with hypoactive sexual desire disorder (HSDD) may benefit from a daily dose of flibanserin, a medication designed to improve sexual desire.
When a woman has HSDD, she loses interest in sex, to the point that it causes her much personal distress. This loss of interest cannot be explained by a medical condition or medication. If the woman has a partner, her relationship may suffer.
It is estimated that about 10% of American women have low sexual desire. Currently, there is no drug approved for treatment of HSDD in the United States.
In 2010, the U.S. Food and Drug Administration (FDA) Advisory Committee voted against approving flibanserin for HSDD, saying that the drug did not perform better than placebo and that the adverse events outweighed any benefits.
This 24-week study, called the BEGONIA trial to distinguish it from previous studies of flibanserin (VIOLET and DAISY), was conducted by American researchers. It varies from its predecessors in that one of the endpoint measurements changed from a daily diary to a questionnaire. The questionnaire method was considered more appropriate for this study.
The BEGONIA trial involved over a thousand premenopausal women with HSDD who had been in heterosexual relationships for a year or longer. Their mean age was 36.6 years.
Roughly half of the women were randomly assigned to take 100 mg of flibanserin once daily at bedtime. The other half were given a placebo. Women indicated their levels of sexual desire, satisfaction, and distress by completing several questionnaires, including the Female Sexual Function Index.
The women also used a daily electronic diary entry to provide information on sexually satisfying events (SSEs). They were asked to report how many sexual events (intercourse, oral sex, masturbation, or genital stimulation by a partner) they had on a given day and whether those events were satisfying or not.
When compared to the women who took the placebo, the women on flibanserin saw increases in sexual desire and number of SSEs. They also reported improvements in overall function and distress.
About 10% of the women taken flibanserin left the study because of adverse events. For women taking the placebo, the discontinuation rate was about 4%. The most common side effects were drowsiness, dizziness, and nausea.
The authors concluded that flibanserin “has the potential to improve sexual desire and sexual function and reduce distress related to loss of sexual desire in premenopausal women with HSDD.” They also reported “no significant safety concerns” with flibanserin treatment as prescribed in this study.
The study was first published online last month in The Journal of Sexual Medicine.
The Journal of Sexual Medicine
Katz, Molly, MD, et al.
“Efficacy of Flibanserin in Women with Hypoactive Sexual Desire Disorder: Results from the BEGONIA Trial”
(Full-text. First published online: May 14, 2013)
Hitt, Emma, PhD
“FDA Advisory Committee Votes Against Flibanserin for Hypoactive Sexual Disorder”
(June 21, 2010)