Health TrialsbyHealthPanel

A Study of Revaree Plus in People With Breast Cancer

ConditionsBreast CancerStage 0 Breast CancerStage I Breast CancerStage II Breast CancerStage III Breast CancerStage 0 Breast CarcinomaStage II Breast CarcinomaStage III Breast CarcinomaHormone-receptor-positive Breast CancerHormone Receptor Positive Breast CarcinomaHormone Receptor Positive Malignant Neoplasm of Breast
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Revaree Plus

    Drug

    Revaree Plus is a hyaluronic acid vaginal suppository

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Hormone-receptor positive breast cancer participantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Vaginal Assessment Scale from baseline to 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

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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