Hyaluronic Acid Vaginal Suppository (Revaree Plus) to Improve Vaginal Health in Women Receiving Aromatase Inhibitor or Tamoxifen for Stage 0-3 Hormone Receptor Positive Breast Cancer

PRIMARY OBJECTIVE:

I. To evaluate the effectiveness of Revaree Plus treatment by determining whether vaginal health (as measured by the Vaginal Assessment Scale) improves from baseline to 8 weeks post-Revaree Plus treatment in women with breast cancer who have complete their primary breast cancer treatment (surgery, chemotherapy, or radiation).

SECONDARY OBJECTIVES:

I. To evaluate the effectiveness of Revaree Plus treatment on vulvar health from baseline to 8 weeks using the Vulvar Assessment Scale (VuAS).

II. To evaluate if the effects of Revaree Plus treatment on vaginal and vulvar health are sustained over time from baseline to week 12.

III. To assess potential benefits of Revaree Plus treatment to participants’ sexual function using patient-reported outcomes (PROs) specific to sexual function (Patient Reported Outcome Measurement Information System [PROMIS] and Female Sexual Function Index [FSFI] sexual function items) at baseline, week 8 and week 12.

IV. To assess objectively vaginal and vulvar symptoms as measured by the GYN Checklist/Gynecological Evaluation for patients who are being seen either the Gynecology or Female Sexual Medicine clinics and completing pelvic exams.

V. To compare the Menopausal Symptom Check List (MSCL), PROMIS, Vulvovaginal Symptom Questionnaire (VSQ), VuAS, and VAS scores of patients followed by Gynecology service to those only seen in the Breast Medicine Service.

VI. To evaluate patient satisfaction with Revaree Plus using the Patient Satisfaction Questionnaire at 12 weeks.

OUTLINE:

Patients insert the Revaree Plus suppository vaginally every 2-3 days for 12 weeks in the absence of unacceptable toxicity. Patients may undergo pelvic exam on study.