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 disorders.
METHODS: The study consisted of three 4-week periods: sildenafil, washout, placebo, 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 orgasm, 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, while 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). Therapeutically significant differences were not noted during the treatment with both 50 mg and 25 mg of sildenafil for arousal and orgasm. The frequency of sexual fantasies and of sexual intercourse, and enjoyment, improved in the women treated with sildenafil (P < 0.05).
CONCLUSIONS: Our study suggests that sildenafil may improve sexual performance of women affected by sexual difficulties such as arousal disorder, and may indirectly improve other aspects of sexual life. Moreover, further studies need to define the use of PDE type 5 inhibitors in this sexual pathophysiology.

RCT Entities:   Population Interventions Outcomes