RightFit
RecruitingPhase 4

A Study of Revaree Plus in People With Breast Cancer

Evaluation of Revaree Plus in Women With Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether Revaree Plus improves vaginal health in people with vaginal dryness during breast cancer treatment. It is for adults with stage 0–3 breast cancer that uses hormones to grow.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and sign a consent form showing you understand the study and agree to join.
  • Have stage 0–3 hormone-receptor positive breast cancer, which uses hormones to grow, confirmed at MSKCC.
  • Be able to answer study questions in English or Spanish.
  • Have finished your main cancer treatment, such as surgery, chemotherapy, or radiation, or be on ongoing maintenance treatment.
  • Be taking an aromatase inhibitor, tamoxifen, or another selective estrogen receptor modulator (SERM). These medicines reduce or block estrogen’s effects.
  • Have no current signs of cancer and no history of other cancers, except non-melanoma skin cancer.
  • Be bothered by vaginal symptoms from low estrogen, such as dryness or pain during sex or an exam.
  • Have a total score of at least 4 on the VAS rating scale.

Who can't join

  • Be unable to give informed consent to join.
  • Have vaginal bleeding with an unknown cause within 12 months before joining.
  • Use hormone replacement treatment in the vagina or for the whole body. You must stop it for 4 weeks before joining.
  • Use external estrogen products or nonhormonal moisturizers. You must stop them for 4 weeks before joining.
  • The listing puts “no known allergies” to ingredients in the 10 mg HLA vaginal insert under exclusions. Ask the study team to clarify this rule.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (7)

NJ

NY