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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hormone-receptor positive breast cancer participants | Experimental | Participants will have a diagnosis of Stage 0-III Hormone-receptor positive breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revaree Plus | Drug | Revaree Plus is a hyaluronic acid vaginal suppository |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shari Goldfarb, MD | Contact | 646-888-5080 | goldfars@mskcc.org | |
| Jeanne Carter, PhD | Contact | 646-888-5076 | carterj@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Shari Goldfarb, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent Only) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| Memorial Sloan Kettering Monmouth (Consent Only) | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen (Consent Only) | Recruiting | Montvale | New Jersey | 07645 | United States |
|
| Memorial Sloan Kettering Cancer Center Suffolk-Commack (Consent Only) | Recruiting | Commack | New York | 11725 | United States |
|
| Memorial Sloan Kettering Westchester (Consent Only) | Recruiting | Harrison | New York | 10604 | United States |
|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10021 | United States |
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| Memorial Sloan Kettering Nassau (Consent Only) | Recruiting | Uniondale | New York | 11553 | United States |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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