OBJECTIVE

To evaluate the efficacy and safety of a single injection session of cross-linked hyaluronic acid gel for vulvovaginal atrophy, versus placebo.

DESIGN

Two-step study comprising a 12-week randomised, placebo-controlled, single-blind phase, followed by an open-label phase. Eligible postmenopausal women with vulvovaginal atrophy were randomised (2:1) to a single injection session of either hyaluronic acid or placebo. This is the report of the single-blind phase.

MAIN OUTCOME MEASURES

The primary outcome was the mean change in the severity score for the most bothersome symptom at 12 weeks compared with baseline. Secondary outcomes included differences in scores for individual vulvovaginal atrophy symptoms, score on the Female Sexual Function Index and vaginal pH.

RESULTS

A total of 116 of the 117 patients in the randomised population contributed outcome data to the study (79 receiving hyaluronic acid and 37 placebo). Compared with baseline, the mean score for the severity of the most bothersome symptom was significantly reduced in the hyaluronic acid arm at 12 weeks (between-group difference [95 % confidence interval]: -0.58 [-1.01; -0.16], p = 0.008). Similarly, there were significant reductions in mean scores for dryness (-0.87 [-1.27; -0.47]; p < 0.001) and dyspareunia (-0.65 [-1.09; -0.21]; p = 0.004) and improvement in score on the Female Sexual Function Index (3.81 [0.91; 6.72]; p = 0.011) in the hyaluronic acid group. There were no differences in itching/irritation, pain or vaginal pH in either group. Hyaluronic acid treatment was well tolerated.

CONCLUSIONS

A single injection session of cross-linked hyaluronic acid is effective in reducing vulvovaginal symptoms and sexual dysfunction compared with placebo at 12 weeks, making it a suitable management option for moderate to severe vulvovaginal atrophy symptoms.

TRIAL REGISTRATION

NCT04219722 (https://clinicaltrials.gov/study/NCT04219722).