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