Presentation Authors: Irwin Goldstein*, San Diego, CA, James Simon, Washington, DC, Andrew Kaunitz, Jacksonsille, FL, Corrado Altomare, Florham Park, FL, Yuki Yoshida, Julie Zhu, Florham Park, NJ, Samuel Schaffer, Graziella Soulban, Blainville, Canada
Introduction: A multicenter, randomized, double-blind, placebo-controlled trial assessed efficacy and safety of ospemifene 60 mg QD in 631 postmenopausal women (age 40-80) with moderate to severe vaginal dryness as the most bothersome symptom (MBS) of VVA due to menopause. The primary aim was validation of vulvar photography as an objective measure of vulvar health. The secondary aim was to compare Vulvar Imaging Assessment Scale (VIAS) data from photographs to visual study measures assessed by investigators at each site, including Vaginal Health Index (VHI), and Vulvar Health Index (VuHI).
Methods: Photographs from sites were sent to a central monitoring system, uploaded to a dedicated website and accessed by three expert reviewers who independently assessed vulvar blinded images using a calibrated standardized monitor. Photographs were graded (none/mild/moderate/severe 0-3, cannot evaluate) for 9 criteria: labia majora loss, labia minora loss, clitoris size, urethral glans prominence, introital stenosis, introital pallor, introital erythema, introital moisture, mucosal inflammation. VHI evaluated vaginal fluid secretion, overall elasticity, pH, condition of epithelial mucosa, moisture as normal/mild/moderate/severe. VuHI rated vulvar appearance of labia majora, labia minora, clitoris, introitus appearance/elasticity, color, discomfort, pain as normal/mild/moderate/severe.
Results: 316 ospemifene and 315 placebo subjects were randomized. VIAS, range 0-27, was graded at baseline (ospemifene, 13.8; placebo, 14.1) and week 12, lower values showing better vulvovaginal health. The difference between treatment groups in least square (LS) mean change from baseline was -1.0 (p = 0.0118) at week 12, representing a greater decrease in the ospemifene group relative to placebo. VHI, range 5-25, was graded at baseline (13.0 in both groups) and week 12, higher values being better vaginal health. The difference between groups in LS mean change from baseline was week 4: 2.5, week 8: 2.9, week 12: 2.8 (all p < 0.0001), with greater increases in the ospemifene group. VuHI, range 0-21, was graded at baseline and week 12, with lower values indicating better vulvar health. The mean VuHI total score at baseline (ospemifene, 7.6; placebo, 7.7) was similar in both groups. The difference between groups in LS mean change from baseline was -0.8 (p = 0.0002) at week 4 and -1.1 to -1.2 at weeks 8 and 12 (both p < 0.0001), a statistically significant decrease in the ospemifene group compared to placebo.
Conclusions: Evaluation of vulvar health from photograph images to assess MBS of menopausal women should be considered for future trials.
Source of Funding: Duchesnay, Inc.