Sildenafil Treatment Of Women With Antidepressant-Associated Sexual Dysfunction: A Randomized Controlled Trial

UroToday - Treatment emergent sexual dysfunction is a frequent adverse effect occurring with medication use and is a major influence for premature treatment discontinuation, which leads to treatment failure and costly disease management outcomes.


Sexual dysfunction is recognized as being associated with selective and nonselective serotonin reuptake inhibitor (SRI) antidepressants, the most frequently prescribed medications for outpatients aged 18 to 65 years in the United States, and is estimated to occur in 30% to 70% of men and women treated for major depression. Although numerous strategies have been proposed for managing sexual dysfunction associated with SRI treatment, the selective type 5 phosphodiesterase inhibitors, limited to studies involving men, have demonstrated the best evidence-based data to support broad based and clinically meaningful treatment efficacy. No randomized controlled trial (RCT) has demonstrated effectiveness for women, who compared with men, are prescribed antidepressants at rates of 2 to 1 and can be expected to represent the larger number of patients needing relief from sexual dysfunction associated with SRI treatment. Without evidence-based data to treat sexual function associated with SRIs in women, clinicians lack the confidence to manage it effectively, which leaves patients exposed to excess random pharmacology.


The objective of the current trial was to use a protocol similar to our previous study involving men with sexual dysfunction associated with SRI treatment to assess the efficacy of sildenafil in the treatment of women, specifically women whose major depressive disorder in remission while taking a stable dose of SRI antidepressants and who did not have a preexisting sexual dysfunction but due to the treatment had sexual dysfunction manifest as dysfunction of orgasm (delay) or arousal (lubrication). Recognizing the potential importance of hormonal factors on nitric oxide signaling involved in sexual function in women with depression, endocrine measures were examined.

The prevalence of sexual problems was high, with 96% of women reporting more than one complaint. They reported disturbances in desire (88%), subjective arousal (81%), lubrication (80%), orgasm delay (99%), and other difficulties (24%), which included anorgasmia, pain, and lack of pleasure. The difference in the Clinical Global Impression scale sexual function improvement showed a significant difference between groups (P=.03). Clinically, 72% of women taking sildenafil reported improvement compared with 27% on placebo. On the secondary outcome measures, the sildenafil group had a higher mean (SD) improvement on orgasm (p=.01) than women taking placebo. These findings are important not only because women experience major depressive disorder at nearly double the rate of men, and because they experience greater sexual dysfunction than men, but also because it establishes that selective phosphodiesterase type 5 inhibitors are effective in both sexes for treating this bothersome treatment-associated adverse effect in patients who have been effectively treated for depression, but need to continue on their medication to avoid relapse or recurrence, and reduce the current high rates of premature medication discontinuation.


Written by H. George Nurnberg, MD, as part of Beyond the Abstract on UroToday.


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