Microdose transdermal estrogen therapy for relief of vulvovaginal symptoms in postmenopausal women.
OBJECTIVE
The aim of this study was to investigate the effectiveness of microdose transdermal 17beta-estradiol (E2) therapy in postmenopausal women with moderate to severe vulvovaginal symptoms.


METHODS
This report is based on a subset of 121 women who reported most bothersome moderate or severe vulvovaginal symptoms at baseline, from a previous randomized, double-blind, placebo-controlled, multicenter study of 425 healthy, symptomatic, postmenopausal women. Recruits had experienced at least 7 moderate or severe hot flushes daily for at least 1 week or at least 50 moderate or severe hot flushes per week for at least 1 week. Effects on coprimary efficacy variables have been reported previously. Participants received low-dose transdermal E2 plus levonorgestrel (n = 43; nominal delivery 0.023 mg/d E2/0.0075 mg/d levonorgestrel), microdose E2 (n = 42; nominal delivery 0.014 mg/d), or placebo (n = 36) for 12 weeks. Secondary efficacy variables reported herein include mean change from baseline in vaginal pH and vaginal maturation index, the proportion of women with symptoms of vulvar and vaginal atrophy at baseline and week 12, and the proportion of women with moderate-to-severe symptoms of vulvar and vaginal atrophy.


RESULTS
Microdose transdermal E2 treatment was associated with a consistent benefit versus placebo in women with vulvovaginal atrophy. There was a statistically significant difference between both E2 versus placebo for changes in vaginal pH and vaginal maturation index.


CONCLUSIONS
Microdose transdermal E2 offers a useful addition to the therapeutic armamentarium for postmenopausal women in whom vulvovaginal symptoms are particularly troublesome.
Bachmann
Gloria A
GA
Department of OB/GYN, Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey, New Brunswick, NJ 08904, USA. bachmaga@umdnj.edu
Schaefers
Matthias
M
Uddin
Alkaz
A
Utian
Wulf H
WH
D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D001284:Atrophy; D004311:Double-Blind Method; D004958:Estradiol / Q000627:therapeutic use*; D015914:Estrogen Replacement Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D006863:Hydrogen-Ion Concentration; D016912:Levonorgestrel / Q000627:therapeutic use; D008875:Middle Aged; D017698:Postmenopause / Q000187:drug effects* / Q000502:physiology; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014481:United States; D014621:Vagina / Q000187:drug effects* / Q000473:pathology; D014844:Vulva / Q000187:drug effects* / Q000473:pathology
D004958:Estradiol; D016912:Levonorgestrel