|September 2010 · Vol. 22, No. 09
UPDATE: SEXUAL DYSFUNCTION
A dearth of approved drugs for desire and arousal disorders frustrates women and clinicians alike.
In the fifth edition of DSM, hypoactive sexual desire disorder and female sexual arousal disorder may be subsumed in a new category: “Sexual interest/arousal disorder in women”
In phase 2 trials, flibanserin proved to be superior to placebo in improving sex drive in women
All aspects of female sexual function—desire, arousal, orgasm, and pain—improved significantly among postmenopausal women using intravaginal DHEA
In the trials described in this article, simple enrollment and increased focus on sexuality improved sexual function by as much as 30%
Dr. Levy reports no financial relationships relevant to this article.Since sildenafil (Viagra) was approved by the US Food and Drug Administration to treat erectile dysfunction, women have been calling for research and development of treatments for female sexual dysfunction.Despite considerable research documenting improvement in sexual responsiveness, genital sensation, and overall well-being among women who were given testosterone after undergoing bilateral oophorectomy, there remains only one testosterone formulation for women. A combination of synthetic estrogen and methyl testosterone (Estratest; Abbott) is indicated for management of moderate to severe vasomotor symptoms associated with menopause in patients who do not respond to estrogens alone.In the testing stage from BioSante is LibiGel, a transdermal testosterone product. Acrux is developing Luramist, a daily testosterone spray. Proctor & Gamble’s efforts to gain approval of a testosterone-containing transdermal patch (Intrinsa) for treatment of low libido were unsuccessful, largely because of concern about potential increases in the risks of coronary artery disease and breast cancer. Pivotal trial data did not demonstrate enhanced risk, but the numbers were too small and the timeframe too short (a maximum follow-up of 2 years) to establish an effect, so the FDA asked for long-term studies. In 2006, European regulators approved Intrinsa to treat low sexual desire in surgically menopausal women.Then there’s flibanserin, which also failed to win approval from an FDA advisory committee after numerous concerns were raised about its safety and efficacy in premenopausal women.The lack of approved drugs leaves gynecologists and women’s health providers with little to offer our patients who are distressed by sexual dysfunction.
Dr. Levy is Medical Director of the Women’s Health Center, Franciscan Health System, in Federal Way, Wash. She serves on the OBG Management Board of Editors.
In this Update, I discuss: