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A PROSPECTIVE, PLACEBO-CONTROLLED TRIAL OF SILDENAFIL IN WOMEN WITH SEXUAL DYSFUNCTION

Omid Rofeim, Karen Weiss, Edward Hill, Pamela Shrock, Nabet G Kasabian, Bruce R Gilbert

Introduction and Objectives:
It is estimated that sexual dysfunction affects up to 40% of women in the United States. Use of Sildenafil in previous studies for women with spinal cord injury, postmenopausal state, psychotropic-induced, and anti-depressant-induced sexual dysfunction has produced mixed results. We used Sildenafil in a prospective, placebo-controlled trial, for the treatment of sexual dysfunction in women.

Methods:
Twenty-four women were entered into the study which was approved by our Institutional Review Board. Eleven patients completed the study. Mean age was 51.2 years with a range of 23 to 68 years. Of the 11 patients, the main complaints were anorgasmia (54%), decreased libido (45%), and decreased lubrication (45%). The inclusion criteria were age more than 21 years, negative pregnancy test, use of contraception during the study, absence of active neoplastic, cardiac and cerebrovascular diseases, not taking nitrates, and willingness to complete several questionnaires. A urologist, a gynecologist, and a psychologist interviewed each patient. An examination was performed by one of the physicians. An oral dose of 50 mg Sildenafil was given to each patient and the vital signs were measured in a monitored setting for 1-2 hours. Prior to this trial of Sildenafil, each patient completed a Female Sexual Assessment Inventory (FSAI), which measures several components of female sexual function. The patient was then sent home with 2 different color capsules (3 placebo and 3 Sildenafil, 50 mg). After use of each capsule, an additional FSAI was completed.

Results:
No significant changes were noted in the blood pressure and heart rate with Sildenafil. The mean baseline FSAI score was 27.6. The overall mean FSAI score for placebo and Sildenafil were 34.9 and 37.2 (p=0.576), respectively. The mean baseline FSAI score was significantly lower compared to either placebo or Sildenafil (p<0.02). The order of taking Sildenafil or placebo did not alter the response. There were 2 patients who had a significant response to Sildenafil as compared to placebo. One with a complaint of decreased vaginal lubrication and the other with anorgasmia.

Conclusions:
Sildenafil did not cause major hemodynamic changes during this study. Despite reported success rates of 40%-80% in men with erectile dysfunction, Sildenafil did not show significant improvement in female sexual response compared to placebo in our study. However, of some interest, participation in the study was associated with a moderate increase in the subjective sexual response from the baseline.