Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy

被引:42
|
作者
Freedman, Murray [2 ]
Kaunitz, Andrew M. [3 ]
Reape, Kathleen Z. [1 ]
Hait, Howard [1 ]
Shu, Haibin [1 ]
机构
[1] Duramed Res Inc, Bala Cynwyd, PA 19004 USA
[2] Med Coll Georgia, Dept Obstet & Gynecol, Augusta, GA 30912 USA
[3] Univ Florida, Coll Med, Dept Obstet & Gynecol, Jacksonville, FL USA
来源
MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY | 2009年 / 16卷 / 04期
关键词
Estrogen therapy; Vaginal atrophy; Vulvovaginal atrophy; Vaginal dryness; Dyspareunia; EFFICACY; PLACEBO;
D O I
10.1097/gme.0b013e318199e734
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
Objective: The aim of this study was to evaluate low-dose synthetic conjugated estrogens A (SCE-A) cream administered twice weekly for the treatment of moderate to severe vulvovaginal atrophy (VVA) in a symptomatic postmenopausal population. Methods: In a multicenter, double-blind, randomized, placebo-controlled study, 305 women with symptoms of VVA were treated with either I g SCE-A cream (n = 150) or matching placebo (n = 155) for a period of up to 12 weeks. Participants had to have a vaginal pH of greater than 5, less than or equal to 5% superficial cells on a vaginal smear, and at least one of five symptoms of VVA (dryness, soreness, irritation, pain with intercourse, and bleeding after intercourse) that was moderate or severe in intensity. Women had to select one moderate or severe symptom as the most bothersome. Results: Efficacy was assessed at 2, 3, 4, 8, and 12 weeks and included the change from baseline in the severity of the most bothersome symptom (MBS), maturation index, and pH. Most women identified vaginal dryness as the MBS (48%) followed by pain with intercourse (31.3%). A statistically significant increase in the maturation index and significant decreases in pH and severity of the MBS were observed for those treated with SCE-A vaginal cream compared with placebo. Conclusions: A low dose (1 g = 0.625 mg) of SCE-A vaginal cream administered twice weekly was shown to be effective compared with placebo in treating VVA in postmenopausal women for the three coprimary efficacy measures of maturation index, pH, and severity of the MBS.
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页码:735 / 741
页数:7
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