The purpose of this guidance is to assist sponsors in developing drugs for the treatment of low sexual interest, desire, and/or arousal in women. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall clinical development program, with a focus on phase 3 trial designs, to support an indication for the treatment of these conditions. This draft guidance is intended to serve as a focus for continued discussions among the Division of Bone, Reproductive, and Urologic Products, pharmaceutical companies, the academic community, and the public.

This guidance focuses on conditions of low sexual interest, desire, and/or arousal that cause marked distress or interpersonal difficulty in women, including female sexual interest/arousal disorder (FSIAD), hypoactive sexual desire disorder (HSDD), and female sexual arousal disorder (FSAD). The symptoms of these conditions are NOT considered to be caused by:

  • A coexisting medical or psychiatric condition
  • Problems within the relationship
  • The effects of a medication or other drug substance

The diagnostic criteria for disorders of low sexual interest, desire, and/or arousal in women were recently revised in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM). These revisions have not been universally accepted by the scientific community. The recommendations proposed in this guidance can be applied to the diagnostic framework outlined in both the fourth and fifth editions of the DSM.

This guidance does not address the development of drugs to treat other forms of female sexual 43 dysfunction such as orgasmic disorder, genito-pelvic pain/penetration disorder, or substance/medication-induced sexual dysfunction in women. In addition, this guidance does not address the treatment of dyspareunia, which is often, but not always, related to vulvovaginal atrophy (VVA) associated with menopause. VVA symptoms are addressed in a separate guidance.

Although this guidance discusses the selection of endpoints for clinical trials, it does not address detailed design considerations for patient-reported outcome (PRO) instruments. Those issues are addressed in the guidance for industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PRO guidance).In addition, this guidance does not contain discussion of the general issues of statistical analysis or clinical trial design. Those topics are addressed in the ICH guidances for industry E9 Statistical Principles for Clinical Trials and E10 Choice of Control Group and Related Issues in Clinical Trials, respectively.

Posted on the FDA website on 25 October 2016