Efficacy and safety of alprostadil cream for the treatment of female sexual arousal disorder: a double-blind, placebo-controlled study in chinese population.
BACKGROUND
To date, no approved medication is available for the treatment of female sexual arousal disorder (FSAD).


OBJECTIVE
The purpose of this study was to evaluate the clinical efficacy and safety of a novel alprostadil topical cream for the treatment of FSAD.


METHODS
This was a multicenter, randomized, double blind, placebo-controlled, parallel design dose-ranging study. Four hundred female patients with FSAD (22-62 years of age), after a 4-week nontreatment baseline period, were provided with 10 blinded doses of 500, 700, or 900 mcg alprostadil or a placebo cream to be applied to the clitoris and the G-spot in the vagina prior to vaginal intercourse.


METHODS
The primary efficacy end point was the arousal success rate (equal number of the Yes responses to Question 3 of the Female Sexual Encounter Profile [FSEP] or number of the sexual encounters). Secondary endpoints included the Female Sexual Function Index (FSFI), Global Assessment Questionnaire, other FSEP question responses, and post-treatment changes in Female Sexual Distress Scale.


RESULTS
A total of 374 FSAD patients completed the study. Primary efficacy analysis of the intent-to-treat (ITT) population showed a significant increase in arousal success rates with dose. Arousal success rates at the end of the total evaluation period were 33.1%, 46.3% (P = 0.0161), 43.5% (P = 0.0400), and 53.9% (P = 0.0002) in the placebo, 500, 700, and 900 mcg alprostadil groups, respectively. The changes of the FSFI score, relative to baseline were 14.7%, 20.7% (P = 0.067), 21.7% (P = 0.035), and 22.9% (P = 0.002) for the placebo, 500, 700, and 900 mcg treatment groups, respectively. The other secondary efficacy end point values showed a consistent trend in support of the primary efficacy results.


CONCLUSIONS
These results demonstrated that the application of topical alprostadil prior to vaginal intercourse significantly improved the sexual arousal rate of the subjects with FSAD.
Liao
Qinping
Q
Department of Obstetrics and Gynecology, The First Hospital of Peking University, Beijing, China. qinping_liao@sohu.com
Zhang
Miao
M
Geng
Li
L
Wang
Xiangping
X
Song
Xuehong
X
Xia
Pei
P
Lu
Tao
T
Lu
Mingqi
M
Liu
Vivian
V
D000328:Adult; D000527:Alprostadil / Q000008:administration & dosage* / Q000009:adverse effects; D001143:Arousal / Q000187:drug effects; D002681:China; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D012725:Sexual Behavior / Q000187:drug effects; D020018:Sexual Dysfunctions, Psychological / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D016896:Treatment Outcome; D014622:Vaginal Creams, Foams, and Jellies; D014665:Vasodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
D014622:Vaginal Creams, Foams, and Jellies; D014665:Vasodilator Agents; D000527:Alprostadil