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Platelet-rich plasma injection for Vulvovaginal Atrophy

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Recruiting

Research Sponsored by Medstar Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women (assigned female at birth) at least 18 years old with a clinical diagnosis of GSM

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at 6 weeks and 6 months post-intervention

Awards & highlights

Study Summary

This trial is testing whether injections of platelet-rich plasma (PRP) into the anterior vaginal wall can improve sexual functioning in women experiencing symptoms of menopause. PRP is a solution with a high

Who is the study for?

This trial is for English-speaking women, assigned female at birth, who are at least 18 years old and have been diagnosed with genitourinary syndrome of menopause (GSM). Participants should be sexually active, having had sexual activity weekly in the past month. They must also be willing to follow study requirements.Check my eligibility

What is being tested?

The trial is testing if injections of platelet-rich plasma (PRP) into the vaginal wall can improve sexual function in women with GSM. PRP is a concentration of platelets from your own blood that may stimulate cell growth. The study compares PRP injections against saline (saltwater) injections.See study design

What are the potential side effects?

While PRP uses the patient's own blood and is generally considered safe with minimal side effects, potential risks could include pain at injection site, infection, or tissue damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman over 18 with a diagnosis of GSM.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline and at 6 weeks and 6 months post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline and at 6 weeks and 6 months post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline and at 6 weeks and 6 months post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Female Sexual Function Index

Secondary outcome measures

Patient Global Impression of Improvement (PGI-I)

Urinary Distress Inventory (short form) (UDI-6)

Visual analog scale for vaginal dryness (VAS)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Platelet-rich plasma injectionExperimental Treatment1 Intervention

Group II: 0.9% saline injectionPlacebo Group1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medstar Health Research InstituteLead Sponsor

191 Previous Clinical Trials

117,611 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients to participate in this clinical trial?

"Affirmative. The details on clinicaltrials.gov propose that this investigation is actively in search of volunteers. Initially uploaded on March 1, 2024, the most recent revision was made on April 23, 2024. Specifically, the trial aims to recruit a total of 30 participants from one designated site."

Answered by AI

What is the current number of individuals being admitted into this research investigation?

"Indeed, as per clinicaltrials.gov, this research study is actively seeking candidates. Originally posted on March 1st, 2024 and last modified on April 23rd, 2024, the trial aims to enroll 30 participants at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRP Injections for Genitourinary Syndrome of Menopause

2024. "PRP Injections for Genitourinary Syndrome of Menopause". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06028009.

All > Menopause