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PRP Therapy for Genitourinary Syndrome in Breast Cancer Survivors

Phase 2
Recruiting
Led By Kristin E Rojas, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a history of biopsy-proven Ductal carcinoma in situ (DCIS) or Stage I-III breast cancer and must be currently undergoing treatment or have completed primary treatment
Female patients who are age 18 years and older
Must not have
Patients with any systemic or topical hormone replacement therapy within 3 months prior to enrollment, known genital infection, coagulation disorders, or on anticoagulant therapy or turmeric-containing supplements within the prior 2 weeks will be excluded
Women who are pregnant or who plan to become pregnant within the following six months will be excluded since the impact of recent PRP injections to the vulva and the impact on obstetric injury during vaginal delivery has not been studied
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 31 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if PRP injections help breast cancer patients with genitourinary symptoms due to menopause.

Who is the study for?
This trial is for female breast cancer survivors experiencing menopause symptoms in the genital area. They must be over 18, may be on or off endocrine therapy, and have a low vaginal health score. Women using hormones or with coagulation issues can't join.
What is being tested?
The study tests if injecting platelet-rich plasma (PRP) into the vulva and vagina can relieve menopausal genital symptoms in breast cancer patients. It's seeing if this non-hormonal treatment is beneficial.
What are the potential side effects?
Potential side effects of PRP injections might include pain at the injection site, infection risk, bleeding due to needle insertion, and possible allergic reactions to components of the PRP.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have or had early-stage breast cancer and am currently being treated or have finished treatment.
Select...
I am a woman aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not used hormone therapy, had genital infections, blood clotting issues, or taken anticoagulants or turmeric supplements recently.
Select...
I am not pregnant and do not plan to become pregnant in the next six months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 31 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 31 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in GSM symptoms as measured by vulvovaginal symptom questionnaire (VSQ).
Secondary study objectives
Change in Vaginal health index (VHI) Score
Change in sexual-related distress (FSDS-R).
Change in validated female sexual function index (FSFI)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Platelet-rich plasma (PRP) GroupExperimental Treatment1 Intervention
Participants will undergo two sessions of platelet-rich plasma (PRP) injections to the vulva/vagina one month apart.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platelet-rich plasma (PRP)
2009
Completed Early Phase 1
~10

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
949 Previous Clinical Trials
428,437 Total Patients Enrolled
17 Trials studying Breast Cancer
1,837 Patients Enrolled for Breast Cancer
Kristin E Rojas, MDPrincipal InvestigatorUniversity of Miami

Media Library

Platelet-rich plasma (PRP) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05812924 — Phase 2
Breast Cancer Research Study Groups: Platelet-rich plasma (PRP) Group
Breast Cancer Clinical Trial 2023: Platelet-rich plasma (PRP) Highlights & Side Effects. Trial Name: NCT05812924 — Phase 2
Platelet-rich plasma (PRP) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05812924 — Phase 2
~12 spots leftby Sep 2026
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