Premenopausal women affected by sexual arousal disorder treated with sildenafil: a double-blind, cross-over, placebo-controlled study

Objective To verify whether sildenafil is effective in young premenopausal women affected by arousal disorder. Design A double-blind cross-over study. Setting Centre for Sexological Research, Department of Microbiological and Gynaecological Science, University of Catania, Italy. Sample Fifty-three volunteer women aged 22-28 years affected by arousal dis orders. Methods The study consisted of three 4-week periods: sildenafil, washout, p lacebo, by six possible sequences. sildenafil was used at 25 mg or 50 mg. Main outcome measures Efficacy was assessed at baseline and once monthly by the Personal Experiences Questionnaire based on the 5-point Likert scale. The questionnaire quantified subjective arousal (primary endpoint), and org asm, enjoyment, sexual frequency, and the number of sexual fantasies. Results Fifty-one women completed the study. Mean (SD) usage of sildenafil 25mg and 50mg was, respectively, 2.8 (0.8) and 2.7 (1.3) times weekly, whil e mean usage of placebo was 2.8 (1.6) times weekly. During both sildenafil dosages, arousal and orgasm improved with respect to placebo (P < 0.001). T herapeutically significant differences were not noted during the treatment with both 50 mg and 25 mg of sildenafil for arousal and orgasm. The frequen cy of sexual fantasies and of sexual intercourse, and enjoyment, improved i n the women treated with sildenafil (P < 0.05). Conclusions Our study suggests that sildenafil may improve sexual performan ce of women affected by sexual difficulties such as arousal disorder, and m ay indirectly improve other aspects of sexual life. Moreover, further studi es need to define the use of PDE type 5 inhibitors in this sexual pathophys iology.