Treating where it hurts—a randomized comparative trial of vestibule estradiol for postmenopausal dyspareunia

Abstract

Objective 

To compare efficacies of two strengths of estradiol cream applied to the vulvar vestibule and use of silicone lubricant to reduce intercourse pain scores in postmenopausal women with moderate/severe dyspareunia.

Methods 

This pilot randomized comparative trial assigned 50 women to nightly applications of estradiol cream, 50 or 100 μg, for 12 weeks. We asked women to have lubricated penetration twice weekly, with intercourse or performing a tampon test. Pain, recorded in dairies, was rated using the 0-10 Numerical Rating Scale. We assessed biopsychosocial outcomes, urinary symptoms, and measured serum estradiol levels and endometrial stripe thicknesses. We performed physical examinations to determine tenderness levels of the vestibule, vagina, pelvic floor muscles, bladder, uterus, and adnexa. Comparisons were made using two-sample t test, Wilcoxon rank-sum test, or χ²/Fisher's exact test.

Results 

Forty-seven women (94%), with a mean age of 59.7 years, completed the trial. The baseline median intercourse pain score was 8/10 (interquartile range, 6, 8). After 12 weeks, we measured no statistically significant difference between groups in the primary outcome, intercourse pain score, or any secondary outcome measure. For both groups together, the median intercourse pain score diminished by 50% after 4 weeks and 75% after 12 weeks (P < 0.001). The most tender anatomic area, the vulvar vestibule, improved by 82% to 100% (P < 0.001) with therapy. We did not measure a statistically significant difference in serum estradiol levels or endometrial stripe thickness between groups.

Conclusion 

Estradiol cream applied to the vulvar vestibule, paired with precoital silicone lubricant, is a promising alternative to vaginal therapy for dyspareunia.

In Brief

In this study, each of two strengths of estradiol cream significantly reduced dyspareunia scores after prolonged nightly applications to the vulvar vestibule, and there was not a statistically significant difference between strengths in various studied outcomes. The effectiveness and minimal systemic absorption suggest that the vestibule might be an optimal target of dyspareunia research and therapy.