An Open, Uncontrolled Pilot Study on 12-Week Use of VagiVital for Treatment of VulvovaginalAtrophy in Breast Cancer Patients Undergoing Adjuvant Aromatase-Inhibitor Therapy.

Abstract

PurposeThis pilot study assessed the efficacy of 12 weeks of daily treatment with a vaginal gel based on a water-based cellulose gel in reducing the severity of moderate–severe symptoms of vulvovaginal atrophy (VVA) and followed adverse events in female breast cancer patients undergoing treatment with adjuvant aromatase- inhibitor therapy.MethodsIn this open, uncontrolled pilot study, the efficacy and safety of the gel during a treatment period of 12 weeks (daily 1×1 mL) were evaluated (n=28). The gel is made of water and hypromellose, a hydropropylmetyl cellulose, which works by coating the vagina, and was developed to treat moderate–severe symptoms of VVA. The primary efficacy variable was the most bothersome symptom (MBS; among vulvovaginal irritation and itching, vaginal dryness, dysuria, or dyspareunia) self-identified at baseline on a four-point scale.ResultsA total of 28 patients fulfilled all entry criteria and had data available after the start of treatment. Treatment with the gel reduced MBS scores from baseline (n=28, mean 2.71) to week 12 (n=27, mean 1.33, mean reduction 1.37; p=0), and reduced the overall total scores for VVA symptoms from a mean of 5.39 at baseline to 2.25 at week 12 (p=0). Eleven subjects (39%) reported 19 AEs.ConclusionA 12-week treatment with the gel significantly reduced the severity of MBSs and VVA symptoms, improved quality of life, and was safe to use in women with breast cancer undergoing adjuvant aromatase-inhibitor therapy. In view of the beneficial effects of nonhormonal treatments, for cancer patients in particular, the water-based cellulose gel VagiVital is a suitable candidate for first-choice treatment of VVA symptoms in breast cancer patients and in women predisposed to cancer.