Assessment of female sexual dysfunction: review of validated methods.

OBJECTIVE: To review validated methods for the assessment of female sexual function in clinical trials.
DESIGN: Evaluation of recent peer-review literature on sexual function assessment in women.
SETTING: International conference on androgen insufficiency in women. PATIENT(S): Women with sexual dysfunction due to androgen insufficiency or other causes. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Measures of sexual function in women. RESULT(S): Design and measurement problems in the assessment of sexual functioning in women have limited clinical trials in female sexual dysfunction. Objective measures, such as vaginal photoplethysmography or Duplex ultrasound, have been used in some studies but lack standardization and are unsuitable for use in large-scale clinical trials. A variety of interview methods, validated questionnaires, and event log measures have been used for assessing sexual function in recent trials of androgen replacement therapy. Each of these methods has distinct advantages and disadvantages, although validated questionnaires have provided the most reliable findings to date. Recent Food and Drug Administration guidelines on assessment of female sexual function in clinical trials are critically reviewed. CONCLUSION(S): Despite their prevalence and clinical significance, sexual problems in women have often been neglected in clinical trials. A major obstacle in the design of clinical trials in this area has been the need for sensitive and reliable measures of outcome. Of the currently available measures, self-reported event logs or questionnaires are best suited for research or clinical assessment of female sexual function.