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 FSDwere 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 inmean change FSFI total score fromthe 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.