Elsevier

Urology

Volume 53, Issue 3, March 1999, Pages 481-486
Urology

Rapid Communications
Safety and efficacy of sildenafil in postmenopausal women with sexual dysfunction

https://doi.org/10.1016/S0090-4295(98)00633-5Get rights and content

Abstract

Objectives. Sildenafil has been demonstrated to be safe and effective in the treatment of men with erectile dysfunction. The role of sildenafil in treating women with sexual dysfunction has heretofore not been reported. The purpose of this preliminary study was to ascertain the response of postmenopausal women with self-described sexual dysfunction treated with sildenafil for 3 months.

Methods. Thirty-three consecutive postmenopausal women with sexual dysfunction 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 Female Sexual Function (IFSF) and a global efficacy question ([GEQ] Did treatment improve your sexual function?). The IFSF quantifies the domains of desire, quality of sexual intercourse, overall satisfaction with sexual function, orgasm, lubrication, and clitoral sensation.

Results. Of the group, 30 women (91%) completed the study and were available 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 women (21%) noted improvement on the GEQ. Overall, only 6 (18.1%) of 33 patients had a significant (more than 60% improvement in IFSF score) therapeutic response. Clitoral discomfort and “hypersensitivity” occurred in 7 women (21%), 3 of whom withdrew from the study. Other side effects, which did not result 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 postmenopausal women with sexual dysfunction. Overall sexual function did not improve significantly, although there were changes in vaginal lubrication and clitoral sensitivity. The role of sildenafil in treating sexual dysfunction in various cohorts of women remains to be determined.

Section snippets

Study subjects and design

Thirty-three postmenopausal women with self-described sexual dysfunction for a minimum of 6 months were enrolled into this open-label, prospective study. Patients were self-referred and not randomized. Each patient had to be in a stable monogamous relationship with a male partner that had begun at least 6 months earlier. The study was approved and monitored by the institutional review board.

Exclusion criteria included significant cardiovascular disease, major psychiatric disorder not well

Results

The demographic characteristics of the women studied are listed in Table I. The most common symptoms reported by the patients included decreased arousal in 18 (55%), decreased lubrication in 17 (52%), diminished ability or inability to achieve orgasm in 12 (36%), and dyspareunia in 7 (21%).

Of the group, 30 women (91%) completed the study and were available for follow-up at 3 months. The mean baseline IFSF score before therapy was 24.8 ± 9.8. The mean usage of sildenafil was 3.1 ± 1.4 times per

Comment

There has been a dramatic increase in our understanding of the pathophysiology of erectile dysfunction during the past decade. Many of the neurovascular and biochemical events associated with both normal and abnormal erectile function have been described. Concomitantly, a host of therapeutic alternatives has emerged, with varying degrees of success.

More recently, attention has been directed toward understanding the neurovascular events associated with clitoral and vaginal function. Neurogenic

Conclusions

This is the first reported study examining the effects of sildenafil in women with sexual dysfunction. The results suggest that sildenafil is safe, although with limited efficacy in treating postmenopausal women with self-described sexual dysfunction. It should be emphasized that this study did not contain a placebo arm, was limited to postmenopausal women, and used only one dosage. Whether these results can be duplicated in larger and more varied populations remains to be determined.

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1

S. A. Kaplan is on the Speaker’s Bureau for Pfizer, and his spouse is an employee of Pfizer.

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