The following article is part of conference coverage from the 2019 American Association of Nurse Practitioners Annual Meeting (AANP 2019) in Indianapolis, Indiana. Clinical Advisor’s staff will be reporting breaking news associated with research conducted by leading nurse practitioners. Check back for the latest news from AANP 2019.
Women with moderate to severe menopausal vulvar and vaginal atrophy (VVA) and dyspareunia using 17β-estradiol (E2) softgel vaginal inserts benefited from early onset action within 2 weeks, with positive response significantly likely to continue into week 12, according to research presented at the American Association of Nurse Practitioners 2019 annual meeting held June 18 to 23 in Indianapolis, Indiana.
Investigators assessed the onset of action of E2 vaginal inserts in menopausal women with moderate to severe dyspareunia using data from a phase 3 clinical trial (REJOICE, ClinicalTrials.gov Identifier, NCT02253173).
Women in the trial received 4 µg, 10 µg, or 25 µg of E2 softgel vaginal inserts, or placebo inserts for 12 weeks. Eligible responders had 2 or more of the following: vaginal superficial cell percentage >5%, vaginal pH <5.0, or dyspareunia improvement by ≥1 category.
Of the 695 women analyzed, the proportion of responders with all doses of E2 inserts vs placebo at week 2 was 74% to 82% and 24%, respectively; at week 12, proportions were 72% to 80% and 33%.
The odds of women responding at week 2 were 9- to 14- fold higher in the E2 insert arm vs the placebo arm and 5- to 8- fold higher at week 12, indicating that response rates did not greatly vary from week 2 to week 12.
Women from the total population and the E2 vaginal insert group who responded at week 2 highly predicted that they would have a positive response at week 12 (odds ratio, 13.1 and 7.9, respectively).
“[Nurse practitioners] should proactively discuss vaginal health because VVA and dyspareunia are chronic and progressive, yet treatable, in menopausal women,” the investigators noted.
For more coverage of AANP 2019, click here.
Dahir M, Faught B, Graham S, Bernick B, Mirkin S. A 17β-estradiol Softgel Vaginal Insert: Early Onset of Action for Moderate to Severe Menopausal Vulvar and Vaginal Atrophy (VVA) and Dyspareunia. Presentation at: The American Association of Nurse Practitioners Annual Meeting; June 18-23, 2019; Indianapolis, IN. Poster 16.