Recruiting
A Study of Revaree Plus in People With Breast Cancer
The purpose of this study is to find out whether Revaree Plus is effective at improving vaginal health for people who are having symptoms of vaginal dryness during breast cancer treatment.
ClinicalTrials.gov IDNCT07042581
PhasePHASE4
Enrollment60
SponsorMemorial Sloan Kettering Cancer Center
Age18 Years
SexFEMALE
Conditions studied
Breast Cancer, Stage 0 Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, Stage 0 Breast Carcinoma, Stage II Breast Carcinoma, Stage III Breast Carcinoma, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Hormone Receptor Positive Malignant Neoplasm of Breast
About this study
The purpose of this study is to find out whether Revaree Plus is effective at improving vaginal health for people who are having symptoms of vaginal dryness during breast cancer treatment.
Interventions
- Drug: Revaree Plus — Revaree Plus is a hyaluronic acid vaginal suppository
Primary outcomes
- Change in Vaginal Assessment Scale from baseline to 8 weeks (8 weeks)
Eligibility information
Inclusion Criteria:
* ≥18 years of age at the time of signing informed consent.
* Stage 0-3 hormone-receptor positive breast cancer confirmed at MSKCC
* Able to complete study questionnaires in English or Spanish
* Breast cancer patients must have completed primary therapy (surgery, and/or chemotherapy, and/or radiation therapy) or currently on maintenance therapy
* Currently on an aromatase inhibitor or tamoxifen or Selective Estrogen Receptor Modulators (SERM)
* Currently have no clinical evidence of disease
* Reporting being bothered by vaginal symptoms of estrogen deprivation (i.e., vaginal dryness, dyspareunia, or discomfort \[pain with intercourse or examination\])
* A total score of 4 or greater in VAS
* Without history of other cancers (excluding non-melanoma skin cancer)
* Must sign an informed consent indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study
Exclusion Criteria:
* Inability to provide informed consent
* Vaginal bleeding of unknown etiology within 12 months of study entry
* Currently taking hormone replacement therapy \[local or systemic\] (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment)
* Existing use of external estrogens or nonhormonal moisturizers (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment)
* No known allergies to any ingredients in 10mg HLA suppository
Study locations
- Memorial Sloan Kettering Basking Ridge (Consent Only), Basking Ridge, New Jersey 07920 United States
- Memorial Sloan Kettering Monmouth (Consent Only), Middletown, New Jersey 07748 United States
- Memorial Sloan Kettering Bergen (Consent Only), Montvale, New Jersey 07645 United States
- Memorial Sloan Kettering Cancer Center Suffolk-Commack (Consent Only), Commack, New York 11725 United States
- Memorial Sloan Kettering Westchester (Consent Only), Harrison, New York 10604 United States
- Memorial Sloan Kettering Cancer Center, New York, New York 10021 United States
- Memorial Sloan Kettering Nassau (Consent Only), Uniondale, New York 11553 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.