PRP Injection for Sexual Function

(VIP Trial)

No longer recruiting at 1 trial location

Overseen By Neha Gaddam, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Medstar Health Research Institute

Disqualifiers: Pregnancy, Pelvic organ prolapse, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether an injection of platelet-rich plasma (PRP) can improve sexual satisfaction and function. Participants will receive either a PRP injection or a placebo (a saline injection) and will complete questionnaires about their sexual experiences. The study aims to identify any differences in outcomes between the two groups. Women who are sexually active at least once a week and do not have certain medical conditions, such as pelvic organ prolapse or a history of pelvic surgeries, might qualify for this trial. As an unphased study, this trial offers participants the chance to contribute to pioneering research that could enhance sexual health treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this PRP injection is safe for sexual function?

Research shows that platelet-rich plasma (PRP) injections are generally well-tolerated. Studies have found PRP to be safe and effective for conditions like erectile dysfunction. Participants in these studies often experienced positive results with few serious side effects. Most encountered only minor issues, if any, which resolved quickly.

Since this trial tests PRP injections for sexual function, this previous safety data is encouraging. However, treatments can affect people differently. Always consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Platelet Rich Plasma (PRP) injections are unique because they use components from your own blood to potentially improve sexual function. Unlike traditional treatments like medications or hormonal therapy, PRP harnesses growth factors from platelets to promote tissue regeneration and healing. Researchers are excited because this method could offer a natural alternative with fewer side effects and the possibility of enhancing tissue health directly, which might lead to improved function and satisfaction.

What evidence suggests that PRP injection might be an effective treatment for sexual function?

This trial will compare the effects of Platelet Rich Plasma (PRP) injections with a placebo saline injection on sexual function. Studies have shown that PRP can alleviate sexual problems by addressing issues like vaginal dryness, tissue thinning, and looseness. Other research has found PRP effective in improving erectile dysfunction, suggesting it might also aid other sexual function issues. PRP may enhance blood flow and repair tissues, potentially leading to better sexual satisfaction and function. While more research is needed, these findings offer hope that PRP could be a useful option for improving sexual health. ^{1 2 4 6 7}

Who Is on the Research Team?

Alexis Dieter, MD

Principal Investigator

Medstar Health Research Institute

Are You a Good Fit for This Trial?

This trial is for English-speaking women between 18 and 45 years old who are sexually active, either with a partner or through solo activities. They must be able to follow the study's requirements.

Inclusion Criteria

Willingness and ability to comply with the study requirements

English-speaking

I am a woman who has started menstruating.

Exclusion Criteria

I have had cancer in my reproductive organs before.

Pregnancy

I have had surgery involving vaginal or midurethral mesh.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Randomization & Intervention

Participants are randomized to receive either a PRP injection or a placebo injection

1 day

1 visit (in-person)

Follow-up

Participants complete questionnaires and report any adverse events

4 weeks

1 visit (virtual)

Extended Follow-up

Participants complete additional questionnaires and report any adverse events

6 months

1 visit (virtual, optional in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Platelet Rich Plasma
• Saline

Trial Overview

The trial is testing if injecting platelet rich plasma (PRP) into the vaginal wall and around the clitoris can improve sexual satisfaction compared to a placebo saline injection. Participants will receive one injection and answer questionnaires about their sexual function.

How Is the Trial Designed?

Group I: Platelet Rich Plasma Active Control 1 Intervention

Platelet Rich Plasma Injection

Group II: Saline Placebo Group 1 Intervention

Placebo injection of saline

Platelet Rich Plasma is already approved in United States, European Union for the following indications:

Approved in United States as Platelet Rich Plasma for:

• Facet-mediated lumbar low back pain
• Degenerative joint disease
• Chronic pain

Approved in European Union as Platelet Rich Plasma for:

• Orthopedic conditions
• Musculoskeletal disorders
• Pain management

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials

202

Recruited

187,000+

SHE Foundation

Collaborator

Trials

3

Recruited

2,600+

The Patty Brisben Foundation for Women's Sexual Health

Collaborator

Trials

1

Recruited

50+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11228668/

Efficacy and safety of platelet-rich plasma (PRP) in erectile ...

Platelet-rich plasma (PRP) appears to be an effective and safe measure for treating erectile dysfunction (ED). Our research presents a novel therapeutic option ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772973725007027

161 - Autologous Platelet-Rich Plasma as an Adjunctive ...

The findings indicate that PRP, when combined with standard medical therapy, leads to significantly greater improvements in erectile function compared to ...

3.

mdpi.com

mdpi.com/2077-0383/14/16/5832

Application of Platelet-Rich Plasma in Gynaecologic ...

Studies show PRP improves sexual dysfunction (SD) by reducing vaginal dryness, atrophy, and laxity [14,15,16]. It has also shown potential in enhancing ...

4.

wjmh.org

wjmh.org/pdf/10.5534/wjmh.240310

Clinical Effects and Safety Outcomes of Platelet-Rich ...

The primary outcome of the study was the change in erectile function from baseline using the following validated questionnaires: • International ...

5.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0313074

A meta-analysis of controlled and single-arm trials | PLOS One

PRP appears effective in treating erectile dysfunction, but further high-quality, large-sample trials with longer follow-up are needed to fully understand its ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8195577/

Availability of platelet-rich plasma for treatment of erectile ...

As such, review of the current published animal and human data suggests there is no concrete evidence supporting the validity of PRP as a reliable technique for ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1743609522009717

Platelet-rich plasma (PRP) improves erectile function

Intracavernosal PRP injection therapy used as outlined in this trial appears to be a safe and effective short-term treatment for the management of mild to ...