A Pilot Study of a Topical Intervention for Treatment of Female Sexual Dysfunction.

PURPOSE/BACKGROUND: Many investigators reported that pharmacological treatment of female sexual dysfunction (FSD) has been a promising field yet to be explored. The purpose of this pilot study was to investigate the efficacy and safety of a topical cream containing small concentrations of three vasodilators with different mechanisms of action in treating FSD.

METHODS: In this randomized, controlled pilot trial, premenopausal (n = 30) and postmenopausal (n = 30) cases of 21- to 62-year age range with FSD were allocated randomly into 15 given placebo or 15 given active cream in each group. The women included had FSD for more than a 6-month duration and a total score of Female Sexual Distress Scale-Revised of at least 15. Assessing sexual function by measuring female sexual function index (FSFI) during five clinic visits, one at the end of baseline week and at the end of each week of the 4-week treatment period. The primary end point was changed from baseline FSFI total scores to week 4 treatment. Secondary end point included the changes from baseline arousal, desire, orgasm, and satisfaction scores to week 4 treatment.

FINDINGS/RESULTS: The sexual problem reported by patients was orgasmic or/and arousal disorders. In premenopausal cases, active cream led to a high significant increase in mean change FSFI total score from the baseline to week 4 compared with placebo (1.7 ± 1.886 vs 13.35 ± 4.646, respectively; P < 0.0001). Greater improvement of mean change of orgasm and arousal domain score was also observed (0.3 ± 0.45 and 0.35 ± 0.39 vs. 2.66 ± 0.63 and 1.87 ± 0.168, respectively; P < 0.0001). In postmenopausal cases, there were significantly greater improvements with active cream in all sexual functions compared with placebo cream (P < 0.0001). In triple cream, mean change of FSFI total score, orgasm domain score, and arousal score domain were 14.85 ± 6.33, 1.87 ± 0.168 and 2.66 ± 1.182, whereas in the placebo cream, they were 1.54 ± 2.1,0.7 ± 0.76 and 0.22 ± 0.44, respectively. Meanwhile, orgasm scores increased significantly after the use of placebo cream. No serious adverse effects were reported during treatment.

IMPLICATIONS/CONCLUSIONS: The results of the pilot trial suggest that topical cream containing small concentrations of three vasodilators may act synergistically, and was effective in improving arousal, orgasmic, and satisfaction disorder with a safer profile for premenopausal and postmenopausal women with FSD. Further studies are recommended to be conducted using a large number of nondepressive and depressive patients.