All > Platelet Rich Plasma > Menopause

PRP for Genitourinary Syndrome of Menopause

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic in Florida, Jacksonville, FLGenitourinary Syndrome of Menopause+26 MorePRP - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is to test the possible benefits and side effects of platelet-rich plasma for treating menopause symptoms in breast cancer patients. Platelet-rich plasma is made by taking 4-6 tablespoons of blood from a patient's arm and spinning it in a centrifuge to separate the plasma and red blood cells. The platelet-rich plasma is then injected into the patient.

Eligible Conditions
  • Genitourinary Syndrome of Menopause
  • Breast Cancer
  • Female Genitourinary Infection
  • Menopause
  • Stage 1 Breast Cancer
  • Stage IA Breast Cancer
  • Stage II Breast Cancer
  • Stage IIA Breast Cancer
  • Stage III Breast Cancer
  • Prognostic Stage 0 Breast Cancer
  • Stage 2 Breast Cancer
  • Stage IIB Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage 0 Breast Cancer
  • Stage IB Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

4 Primary · 13 Secondary · Reporting Duration: 2 years

2 weeks
Number of participants with treatment-related Adverse Events as assessed by CTCAE v4.0
2 years
VAS pain scores less than or equal to 4
6 months
Change from baseline FSFI score at 6 months
Change from baseline UDI-6 scores at 6 months
Change from baseline VAS/VuAS to 6 months
Change from baseline of DIVA score at 6 months
Change from baseline to 6 months of VHI
Change from baseline to 6 months of VMI
Change from baseline to 6 months of vaginal caliber
Month 6
Change in Day-to-Day Impact of Vaginal Aging score
Change in sexual function
Change in urinary symptoms
Change in vaginal symptoms
Change in vulvar symptoms
Objective vaginal changes
Week 2
Incidence of adverse events
Month 6
Tolerability of planned injection regimen with pain scores

Trial Safety

Safety Progress

1 of 3

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1
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Side Effects for

Hyaluronic Acid
26%Weakness of muscle surrounding injection site
14%Difficulty moving affected shoulder joint
11%Allergic reaction with itchiness
6%Infection
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT02984228) in the Hyaluronic Acid ARM group. Side effects include: Weakness of muscle surrounding injection site with 26%, Difficulty moving affected shoulder joint with 14%, Allergic reaction with itchiness with 11%, Infection with 6%.

Trial Design

2 Treatment Groups

Treatment Group
1 of 2
Treatment of GSM (platelet rich plasma)
1 of 2

Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: PRP · No Placebo Group · Phase 1

Treatment Group
Drug
Experimental Group · 1 Intervention: PRP · Intervention Types: Drug
Treatment of GSM (platelet rich plasma)Experimental Group · 3 Interventions: Therapeutic Autologous Platelet-rich Plasma, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Biological, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PRP
2014
Completed Phase 4
~1840

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,952 Previous Clinical Trials
3,447,765 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,153 Previous Clinical Trials
41,162,711 Total Patients Enrolled
Anita H Chen, MDPrincipal InvestigatorMayo Clinic
Anita H ChenPrincipal InvestigatorMayo Clinic

Eligibility Criteria

Age 18+ · Female Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have experienced menopause through natural means, surgery, or medical treatment.
You experience symptoms such as vaginal itching, burning, dryness, or painful sex.

Who else is applying?

What state do they live in?
Pennsylvania100.0%
How old are they?
65+100.0%
What site did they apply to?
Mayo Clinic in Florida100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%
References

Frequently Asked Questions

Has the Food and Drug Administration authorized platelet-rich plasma for medical use?

"With limited prior evidence of efficacy and safety, PRP was assigned a 1 on our team's scale." - Anonymous Online Contributor

Unverified Answer

What is the ultimate ambition of this clinical experiment?

"This long-term trial is intended to evaluate the amount of adverse events caused by treatment, as well as changes from baseline in Vaginal and Vulvar Assessment Scale (VAS/VuAS), Vaginal Maturation Index (VMI) and Day-to-Day Impact of Vaginal Aging Questionnaire (DIVA). This assessment will span two years." - Anonymous Online Contributor

Unverified Answer

Could you please provide an approximate figure of how many participants are involved in the experiment?

"Affirmative. The clinicaltrials.gov database points to this experiment still actively seeking recruits, which began on September 23rd 2020 and was most recently updated November 9th 2022. A total of 20 people are needed from one location for the trial's completion." - Anonymous Online Contributor

Unverified Answer

Are there any remaining vacancies for test subjects in this research endeavor?

"Affirmative. The trial data on clinicialtrials.gov confirms that the medical study, which was first published on September 23rd 2020 is currently recruiting participants. Twenty patients need to be enrolled from a single site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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