A Novel Therapy for Breast Cancer Survivors With Genitourinary Syndrome of Menopause

Last updated: July 18, 2025
Sponsor: University of Miami
Overall Status: Active - Recruiting

Phase

2

Condition

Breast Cancer

Cancer

Vaginal Atrophy

Treatment

Platelet-rich plasma (PRP)

Clinical Study ID

NCT05812924
20221120
  • Ages > 18
  • Female

Study Summary

The purpose of this study is to determine whether platelet rich plasma (PRP) injections to the vulva and vagina will improve symptoms of genitourinary syndrome of menopause (GSM) in breast cancer patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female patients who are age 18 years and older

  • Patients must have a history of biopsy-proven Ductal carcinoma in situ (DCIS) orStage I-III breast cancer and must be currently undergoing treatment or havecompleted primary treatment.

  • Patients must be found to have a vaginal health index (VHI) score of <15.

  • Patients may be currently using endocrine therapy (ovarian function suppression,tamoxifen, or aromatase inhibitors). Patients not currently using endocrine therapywill also be eligible for participation since patients more than 5 or 10 years fromdiagnosis (and therefore having completed adjuvant endocrine therapy) may beenrolled.

  • Some patients with triple negative breast cancer who receive chemotherapy alsoexperience GSM related to ovarian function decline outside of the setting of ovariansuppression, and therefore patients with either ER+ or ER- breast cancer will beallowed to participate.

  • Patients must provide written informed consent for participation in this study.

  • Patients are allowed to have used non-hormonal moisturizers but if they havepreviously used hormonal moisturizers, they will be asked to stop the use for onemonth prior to the first planned treatment, termed the "washout period", if needed.

Exclusion

Exclusion Criteria:

  • Patients with any systemic or topical hormone replacement therapy within 3 monthsprior to enrollment, known genital infection, coagulation disorders, or onanticoagulant therapy or turmeric-containing supplements within the prior 2 weekswill be excluded.

  • Women who are pregnant or who plan to become pregnant within the following sixmonths will be excluded since the impact of recent PRP injections to the vulva andthe impact on obstetric injury during vaginal delivery has not been studied.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Platelet-rich plasma (PRP)
Phase: 2
Study Start date:
September 26, 2023
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

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