60 Participants NeededMy employer runs this trial

Platelet-Rich Plasma for Female Sexual Dysfunction

YS
Overseen ByYara Sifri, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized, single-blinded, sham-controlled trial evaluates whether a single injection of autologous platelet-rich plasma (PRP) into the distal anterior vaginal wall improves sexual function in women with sexual dysfunction. Sixty participants with a Female Sexual Function Index (FSFI) total score of 26.5 or lower are randomized 1:1 to PRP injection or sterile saline injection. Sexual function, sexual distress, global impression of change, and urinary incontinence symptoms are assessed at baseline, 6 weeks, and 6 months after injection.

Who Is on the Research Team?

CA

Charles Ascher-Walsh, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for women experiencing sexual dysfunction, as measured by a low Female Sexual Function Index (FSFI) score of 26.5 or less. Participants must be able to receive an injection into the vaginal wall.

Inclusion Criteria

FSFI total score ≤ 26.5
English speaking and literate
I am a woman, 18 or older, experiencing sexual dysfunction.

Exclusion Criteria

Pregnant or less than 12 weeks postpartum
Known history of bleeding disorder
I am unable or unwilling to give my consent for the study.

What Are the Treatments Tested in This Trial?

Interventions

  • Autologous Platelet-Rich Plasma (PRP) Injection

Trial Overview

The study compares a single injection of platelet-rich plasma (PRP), made from the participant's own blood, with a placebo saline injection to see if PRP can improve sexual function in women. Participants are randomly assigned to one group or the other.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Participants receiving a PRP InjectionExperimental Treatment1 Intervention
Group II: Participants receiving Saline InjectionPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+