Safety and efficacy of sildenafil in postmenopausal women with sexual dysfunction

Objectives. Sildenafil has been demonstrated to be safe and effective in th e treatment of men with erectile dysfunction. The role of sildenafil in tre ating women with sexual dysfunction has heretofore not been reported. The p urpose of this preliminary study was to ascertain the response of postmenop ausal women with self-described sexual dysfunction treated with sildenafil for 3 months. Methods. Thirty-three consecutive postmenopausal women with: sexual dysfunc tion based on history were entered in this open-label, nonrandomized study. All patients received 50 mg of sildenafil. Efficacy was assessed at weeks 4, 8, and 12 using a newly developed 9-item, self-administered Index of Fem ale Sexual Function (IFSF) and a global efficacy question ([GEQ] Did treatm ent improve your sexual function?). The IFSF quantifies the domains of desi re, quality of sexual intercourse, overall satisfaction with sexual functio n, orgasm, lubrication, and clitoral sensation. Results. Of the group, 30 women (91%) completed the study and were availabl e for follow-up at 3 months. Mean baseline IFSF score before therapy was 24 .8 +/- 9.8. Mean usage of sildenafil was 3.1 +/- 1.4 times per week for the duration of the study. The IFSF score improved to 29.5 +/- 7.6, 30.3 +/- 8 .5, and 31.4 +/- 10.4 at 4, 8, and 12 weeks, respectively (P = 0.25). Mean scores for questions 2 (lubrication), 8 (orgasm), and 9 (clitoral sensation ) improved by 23.2%, 7.4%, and 31.3%, respectively, at 12 weeks. Seven wome n (21%) noted improvement on the CEQ. Overall, only 6 (18.1%) of 33 patient s had a significant (more than 60% improvement in IFSF score) therapeutic r esponse. Clitoral discomfort and "hypersensitivity" occurred in 7 women (21 %), 3 of whom withdrew from the study. Other side effects, which did not re sult in withdrawal from the study, included headache (n = 5), dizziness (n = 4) and dyspepsia (n = 3). Conclusions. The data suggest that sildenafil is well tolerated in postmeno pausal women with sexual dysfunction. Overall sexual function did not impro ve significantly, although there were changes in vaginal lubrication and cl itoral sensitivity. The role of sildenafil in treating sexual dysfunction i n various cohorts of women remains to be determined. (C) 1999, Elsevier Sci ence Inc. All rights reserved.