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.

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Key information

Conditions

Breast Cancer Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Hormone Receptor Positive Breast Carcinoma Hormone Receptor Positive Malignant Neoplasm of Breast Hormone-receptor-positive Breast Cancer Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases Stage 0 Breast Cancer Stage 0 Breast Carcinoma Stage I Breast Cancer Stage II Breast Cancer Stage II Breast Carcinoma Stage III Breast Cancer Stage III Breast Carcinoma

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Memorial Sloan Kettering Basking Ridge (Consent Only), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Revaree Plus

Drug

Revaree Plus is a hyaluronic acid vaginal suppository

Primary outcomes

Change in Vaginal Assessment Scale from baseline to 8 weeks

Time frame: 8 weeks

The primary study objective is to evaluate whether vaginal health improves from baseline to 8 weeks of treatment with Revaree Plus as measured by the Vaginal Assessment Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Jeanne Carter, PhD

CONTACT

[email protected]

646-888-5076

Shari Goldfarb, MD

CONTACT

[email protected]

646-888-5080

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Evaluation of Revaree Plus in Women With Breast Cancer

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2029
First posted: Jun 29, 2025
Registry last updated: Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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