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

Objective To verify whether sildena®l 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 disorders. Methods The study consisted of three 4-week periods: sildena®l, washout, placebo, by six possible sequences. sildena®l was used at 25 mg or 50 mg. Main outcome measures Ef®cacy was assessed at baseline and once monthly by the Personal Experiences Questionnaire based on the 5-point Likert scale. The questionnaire quanti®ed subjective arousal (primary endpoint), and orgasm, enjoyment, sexual frequency, and the number of sexual fantasies. Results Fifty-one women completed the study. Mean (SD) usage of sildena®l 25mg and 50mg was, respectively, 2.8 (0.8) and 2.7 (1.3) times weekly, while mean usage of placebo was 2.8 (1.6) times weekly. During both sildena®l dosages, arousal and orgasm improved with respect to placebo (P , 0.001). Therapeutically significant differences were not noted during the treatment with both 50 mg and 25 mg of sildena®l for arousal and orgasm. The frequency of sexual fantasies and of sexual intercourse, and enjoyment, improved in the women treated with sildena®l (P , 0.05). Conclusions Our study suggests that sildena®l may improve sexual performance of women affected by sexual dif®culties such as arousal disorder, and may indirectly improve other aspects of sexual life. Moreover, further studies need to de®ne the use of PDE type 5 inhibitors in this sexual pathophysiology.