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[Multicenter randomized, double-blind, placebo-controlled trial of prostaglandin E1 cream for female sexual arousal disorder].

Author(s): Zhang M, Liao QP, Yao C, Geng L, Wang XP, Song XH, Zhao J, Lv T, Lv MQ, Chen L, Yao YJ, Xia B, Zhang HZ, Wang QX, Lu JL

Affiliation(s): Department of Obstetrics and Gynecology, Peking University First Hospital, Beijing 100034, China.

Publication date & source: 2010-12-18, Beijing Da Xue Xue Bao., 42(6):727-33.

Publication type: English Abstract

OBJECTIVE: To investigate the efficacy and safety of alprostadil cream in management of female sexual arouse disorder (FSAD), and its appropriate dose for clinical prescription. METHODS: The volunteers were assigned randomly to four groups which received alprostadil cream in different dosage (500 mug, 700 mug and 900 mug) or placebo cream, respectively. The cream was applied to the clitoris and G-spot before coitus. The efficacy was assessed by comparing the satisfactory rate of sexual arousal, the score of female sexual function index (FSFI) and female sex disorder scale (FSDS) and the general appraised question (GAQ) before and after the treatment. The safety was evaluated by the adverse effects that appeared including symptoms, physical and biochemical examination. RESULTS: Totally, 400 women enrolled in this study with 374 assigned to the group for efficacy evaluation and 387 cases to the group for safety analysis. No significant difference was found among the four groups in the demographic characters and sexual baseline. The increase of satisfactory percentage of sexual arousal in the four groups (placebo, 500 mug, 700 mug and 900 mug) was 22.63%, 36.67%, 34.01%, and 44.29%, respectively (P<0.05), and the increase was statistically higher in the 900 mug group than in the placebo group (P<0.0167). The elevated FSFI score above the baseline in the treatment groups (900 mug 22.89, 700 mug 21.69, and 500 mug 20.71) were higher than that in the placebo group (14.68, P<0.05), while the reduced FSDS score below the baseline (900 mug 25.97, 700 mug 21.98, and 500 mug 20.27) were higher than that of the placebo (17.60, P<0.05). No significant difference was found in the four groups in GAQ (P=0.054). The main common adverse effect was topical stimulation. No adverse effect was reported in physical and biochemical examination, electrocardiogram (ECG) or Thinprep cytologic test (TCT). CONCLUSION: Alprostadil cream can treat female sexual arousal disorder effectively with the maximum effect at the dose of 900 mug and without significant adverse effect except for mild topical stimulation.

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