UPDATE: SEXUAL DYSFUNCTION
A dearth of approved drugs for desire and arousal disorders frustrates women and clinicians alike.
IN THIS ARTICLE
Ultimately, the FDA advisory panel voted unanimously to withhold approval of flibanserin for treatment of HSDD in premenopausal women but encouraged the company to continue studies in postmenopausal women. Recruitment is under way for NCT00996372.
Attendees who spoke during the open public hearing on flibanserin, held June 8 in Gaithersburg, Md, had mixed opinions of the drug’s utility in premenopausal women with hypoactive sexual desire disorder (HSDD). Some believe approval of a “female Viagra” is long overdue. Others, not so much.
“In 1920, women were given the right to vote,” said Sue Goldstein, clinical trial coordinator at San Diego Sexual Medicine in San Diego, Calif. “What we’re asking now is that women be empowered again, that they be given the right to choose to be treated with an FDA-approved product for HSDD.” She added: “Once again, we are the forgotten gender.”
Leonore Tiefer, PhD, sees things differently.
“The simple but appealing notion that a new brain drug can help you with [hypoactive sexual desire disorder] because, well, desire is in the brain, has been peddled for the past year as if it were a fancy pair of shoes,” said Tiefer, clinical associate professor of psychiatry at New York University School of Medicine. “Flibanserin is not a choice when it’s promoted by bad science and half-truths and when self-diagnosis checklists are passed off as medical care.” Her last comment was a reference to sexbrainbody.com, a Web site sponsored by Boehringer Ingelheim that offers, among other resources, a “sexual satisfaction checklist.”
Many other attendees had a personal interest in the issue or represented advocacy groups, and their responses were just as mixed.
Michelle King Robson, founder and CEO of Empow-Her, a women’s health media company, favored approval of flibanserin.
“Women are struggling to find solutions to their sexual dysfunction,” she said.
Liz Canner, director of the feature documentary film Orgasm, Inc., which takes as its subject “the strange science of female pleasure,” accused Boehringer Ingelheim of “disease mongering” (and held a viewing of her film in a room down the hall).
One of the last to speak was Amy Allina, program director of the National Women’s Health Network, who asserted that flibanserin offers “little benefit for real women in the real world.”
There may one day be an effective agent for HSDD, she said.
“This drug is not it,” she added.—Janelle Yates, Senior Editor
Intravaginal DHEA improves postmenopausal sexual function
Labrie F, Archer D, Bouchard C, et al. Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women. Menopause. 2009;16(5):923–931.
DHEA has been studied as a treatment for female sexual dysfunction in postmenopausal women, in whom it acts as a precursor for both estrogen and androgen synthesis. In this study by Labrie and colleagues, all aspects of female sexual function—desire, arousal, orgasm, and pain—improved significantly with intravaginal DHEA (TABLE 2).
This phase-3, multicenter, placebo-controlled, randomized clinical trial of 216 participants—50 in each arm—randomized women to placebo or 3.25 mg, 6.5 mg, or 13 mg of DHEA daily. Median age of participants was 58.
The study began with a 4-week baseline screening phase, followed by 12 weeks of placebo or active treatment. Women were enrolled if they were postmenopausal and experienced vaginal dryness or vulvar or vaginal irritation or pain. Most women had moderate to severe symptoms.
Topical or systemic hormone therapy was prohibited, and women who had preexisting cancer (except skin cancer) or endometrial hyperplasia were excluded. The primary endpoint was improvement in the four domains of sexual dysfunction.
Although women were not initially selected for this trial based on measures of personal distress related to their sexual dysfunction (marked distress or interpersonal difficulty is required by DSM-IV for a diagnosis), approximately 50% indicated a desire for improvement on the intake questionnaire. Women were not excluded from this study if they were taking other medications known to affect sexual function, with the exception of systemic or topical hormonal treatment.
The robust results in this study were achieved without increasing circulating levels of estrogen, testosterone, or DHEA beyond the normal postmenopausal range.
TABLE 2
Women using intravaginal DHEA experienced improvement in all four domains of female sexual function
| Domain | Improvement after 12 weeks of 1% DHEA | P value |
|---|---|---|
| Desire | 49% | <.0001 |
| Arousal | 68% | .0004 |
| Orgasm | 75% | <.0001 |
| Dryness (pain) | 57% | .0001 |
What can we offer to our patients?
Female sexual dysfunction is more difficult to categorize and certainly more difficult to measure scientifically than male sexual dysfunction. The distinction between desire, arousal, and pain disorders in women is easily blurred. Certainly, the ability to declare success in clinical trials is straightforward and unequivocal for men. Not so for women.
