Introduction: A considerable number of double-blind randomized controlled studies investigating the effects of pharmaceutical intervention on female sexual functioning have been published in recent years. However, a comparison between outcomes of various studies is difficult as no generally accepted/correct approach to research has been established yet. To be able to translate trial results to daily clinical practice, current limitations and issues in drug intervention studies in female sexual dysfunction (FSD) need to be clarified.
Aim: To evaluate the needs in research into intervention in FSD by reviewing published studies.
Methods: A systematic review of double-blind randomized controlled intervention trials on FSD.
Main outcome measures: Definitions of study populations, inclusion and exclusion criteria, use of power calculations, outcome measures and treatment duration.
Results: A total of 25 double-blind randomized controlled trials investigating the effects of pharmaceutical intervention on female sexual functioning have been published. Of these, 11 studies required the diagnosis of FSD as an inclusion criterion. A standard methodology for research in this field is lacking. Significant differences in population inclusion requirements and tools for the measurement of change in sexual functioning were identified as major limiting factors.
Conclusions: The investigation of FSD is an evolving area in that new definitions and a new model for female sexual functioning have been recently proposed. There is a need for experts in the field and regulating authorities to reach a consensus regarding appropriate inclusion and exclusion criteria for FSD trials and main outcome measures appropriate for the evaluation of drug interventions. This consensus should also determine which treatment effect is considered to be clinically relevant. Treatment efficacy and clinical relevance should be related to outcomes which are meaningful for affected women.