Development of a sexual function questionnaire for clinical trials of female sexual dysfunction.

OBJECTIVE To better evaluate efficacy in clinical trials of drugs as potential treatments for female sexual dysfunctions (FSD), a brief, multidimensional measure of female sexual function was developed. METHODS Data from semistructured interviews with 82 women with or without FSD, aged 19-65 years, generated a pool of 61 items that addressed aspects of female sexual function. On review by a panel, individual items were selected for face validity and clinical relevance. Thirty-one items were used as a sexual function questionnaire (SFQ-V1) in two multicenter, phase II clinical trials totaling 781 women with FSD. Normative data were generated from a sample of 201 women without FSD. RESULTS Factor analysis produced seven domains of female sexual function: desire, physical arousal-sensation, physical arousal-lubrication, enjoyment, orgasm, pain, and partner relationship. The internal consistency of the domains ranged from 0.65 to 0.91, and test-retest reliability ranged from 0.21 to 0.71 for Cohen's weighted kappa and 0.42 to 0.78 for Pearson's correlation coefficient. There was a significant difference between the baseline mean SFQ domain scores of patients with FSD compared with those of women without FSD (p < 0.0001). End-of-study SFQ scores were significantly different for women who reported improvement vs. women who reported no improvement (p < 0.001). CONCLUSIONS The SFQ produced seven domains of female sexual function with excellent internal consistency, moderate to good reliability, excellent discriminant validity, and sensitivity. The results suggest that the SFQ may be a valuable new tool for evaluating and diagnosing subsets of FSD and, ultimately, for evaluating treatments of these disorders.