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Most bothersome symptom in women with genitourinary syndrome of menopause as a moderator of treatment effects

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Objective:

Conjugated estrogens/bazedoxifene (CE/BZA) is indicated to treat moderate/severe menopausal vasomotor symptoms and prevent postmenopausal osteoporosis. This analysis examines the impact of the most bothersome vaginal symptom at baseline on effects of CE/BZA.Methods:

This post hoc analysis used data from a 12-week clinical trial of nonhysterectomized postmenopausal women (n = 664) randomly assigned to double-blind treatment with CE/BZA (0.45/20 mg and 0.625/20 mg), BZA 20 mg, or placebo. At baseline, women indicated which moderate/severe vaginal symptom (dryness, itching/irritation, or pain with intercourse) bothered them most. Repeated measures models were used to explore treatment effects in relationship to the most bothersome symptom. We calculated effect sizes for treatment differences versus placebo (effect sizes: trivial, 0.1; small, 0.2; medium, 0.5; large, 0.8).
Results:

At baseline, 52% of women selected pain with intercourse, 35% selected vaginal dryness, and 13% selected vaginal itching/irritation as most bothersome. For these three symptom groups respectively, CE/BZA was associated with statistically significant improvements in Menopause-Specific Quality of Life sexual functioning (effect size: 0.45/20 mg, −0.36, −0.30, −0.67; 0.625/20 mg, −0.37, −0.40, −0.26) and/or overall score (effect size: 0.45/20 mg, −0.29, −0.41, −0.78; 0.625/20 mg, −0.41, −0.48, −0.68). Both those doses significantly improved the ease of lubrication item on the Arizona Sexual Experiences Scale in those with pain with intercourse (effect size: 0.45/20 mg, −0.43; 0.625/20 mg, −0.50) and produced some statistically significant improvements in vaginal cell counts in women with dryness or pain with intercourse as the most bothersome symptom. The higher dose was associated with greater treatment satisfaction on the Menopause Symptoms Treatment Satisfaction Questionnaire versus placebo in women who selected pain with intercourse (effect size: 0.40) or dryness (effect size: 0.43) as most bothersome.
Conclusions:

The approved dose of CE/BZA had clear benefits, particularly in women with pain with intercourse (the most common bothersome symptom), in whom it improved lubrication, superficial cell counts, and sexual functioning.
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Keywords: Bazedoxifene; Conjugated estrogens; Genitourinary syndrome of menopause; Menopause; Quality of life; Vagina; Vulvar-vaginal atrophy

Document Type: Research Article

Affiliations: 1: University of Virginia Health System, Charlottesville, VA 2: Pfizer Inc, Groton, CT 3: Pfizer Ltd, Tadworth, Surrey, UK 4: Pfizer Inc, Collegeville, PA.

Publication date: October 1, 2016

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