Kelly M Tucker1, Keshav Godha2, Sebastian Mirkin2, David F Archer1. 1. CONRAD Clinical Research Center, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA. 2. TherapeuticsMD, Boca Raton, FL.
Abstract
OBJECTIVE: The aim of the study was to determine the utility of vaginal pH as a marker of menopause and vulvar and vaginal atrophy (VVA) before and after local estrogen treatment. METHODS:Vaginal pH was determined using standard pH paper strips in two clinical trials involving postmenopausal women with signs and symptoms of VVA evaluated before and after intervention with vaginal estradiol in softgel capsules. The utility of vaginal pH was evaluated as a screening method for VVA due to menopause and correlations were analyzed between vaginal pH and VVA symptoms, physical changes, and maturation of the vaginal epithelium. RESULTS:Changes in vaginal pH were significantly correlated with changes in superficial and parabasal cell counts; vaginal epithelial changes of color, integrity, thickness, and secretion; and the VVA symptoms of vaginal dryness and dyspareunia (vaginal pain with intercourse). CONCLUSIONS:Vaginal pH consistently correlated with parabasal and superficial cells and the visual vaginal epithelial changes and symptoms of dryness and dyspareunia, and is thus a simple outpatient procedure that reflects the hormonal milieu and its effects on the vaginal epithelium.
RCT Entities:
OBJECTIVE: The aim of the study was to determine the utility of vaginal pH as a marker of menopause and vulvar and vaginal atrophy (VVA) before and after local estrogen treatment. METHODS: Vaginal pH was determined using standard pH paper strips in two clinical trials involving postmenopausal women with signs and symptoms of VVA evaluated before and after intervention with vaginal estradiol in softgel capsules. The utility of vaginal pH was evaluated as a screening method for VVA due to menopause and correlations were analyzed between vaginal pH and VVA symptoms, physical changes, and maturation of the vaginal epithelium. RESULTS: Changes in vaginal pH were significantly correlated with changes in superficial and parabasal cell counts; vaginal epithelial changes of color, integrity, thickness, and secretion; and the VVA symptoms of vaginal dryness and dyspareunia (vaginal pain with intercourse). CONCLUSIONS: Vaginal pH consistently correlated with parabasal and superficial cells and the visual vaginal epithelial changes and symptoms of dryness and dyspareunia, and is thus a simple outpatient procedure that reflects the hormonal milieu and its effects on the vaginal epithelium.
Authors: Caroline M Mitchell; Nanxun Ma; Alissa J Mitchell; Michael C Wu; D J Valint; Sean Proll; Susan D Reed; Katherine A Guthrie; Andrea Z Lacroix; Joseph C Larson; Robert Pepin; Daniel Raftery; David N Fredricks; Sujatha Srinivasan Journal: Am J Obstet Gynecol Date: 2021-03-04 Impact factor: 10.693