NCT05769283

Brief Summary

The goal of this clinical trial is to learn about an injection of platelet rich plasma into the vaginal wall and around the clitoris. The main questions it aims to answer are:

  • To see if a PRP injection improves sexual satisfaction
  • To learn the effect of PRP injections on sexual function Participants will get assigned to getting a one time PRP injection or a placebo injection. They will answer questionnaires about their sexual function at their first visit and their followup visit. The investigators will then compare the two groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

August 18, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2025

Completed
Last Updated

October 22, 2025

Status Verified

October 1, 2025

Enrollment Period

1.6 years

First QC Date

February 15, 2023

Last Update Submit

October 20, 2025

Conditions

Sexual BehaviorSexual Activity

Outcome Measures

Primary Outcomes (1)

  • Sexual Function

    To determine if PRP injections into the anterior vaginal wall and peri-clitoral region alter sexual function or satisfaction in sexually active women without a prior history of FSD. This will be determine using the Female Sexual Function Index (FSFI) pre and post procedure. The FSFI is a validated questionnaire with 6 domains of desire, subjective arousal, lubrication, orgasm, satisfaction, and pain with a scale of 0-36. A higher score on this questionnaire correlates with higher sexual satisfaction.

    6 months

Secondary Outcomes (3)

  • Overall effect

    6 months

  • Sexual Dysfunction

    6 months

  • Pain with Injection

    Day of procedure

Study Arms (2)

Platelet Rich Plasma

ACTIVE COMPARATOR

Platelet Rich Plasma Injection

Other: Platelet Rich Plasma

Saline

PLACEBO COMPARATOR

Placebo injection of saline

Other: Saline

Interventions

Platelet Rich PlasmaOTHER

Platelet rich plasma (PRP) is autologous blood which has been centrifuged to separate the supernatant resulting in a solution with high concentration of platelets. It is then injected into the anterior vaginal wall and periclitoral area

Also known as: O Shot
Platelet Rich Plasma
SalineOTHER

Normal Saline to be injected into the anterior vaginal wall and periclitoral area

Saline

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAssigned female at birth
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Menarchal women (assigned female at birth)
  • Age ≥ 18 years of age and \<51
  • · Sexually active with at least one episode of sexual activity per week defined as follows:
  • Partnered or solo penetrative or non-penetrative stimulation of the clitoris or vagina
  • English-speaking
  • Willingness and ability to comply with the study requirements

You may not qualify if:

  • Pregnancy
  • Pelvic organ prolapse (defined as symptomatic prolapse protruding beyond the hymen)
  • History of prior vaginal mesh or midurethral mesh sling surgery
  • History of pelvic radiation
  • History of or diagnosis of chronic pelvic pain
  • History of female genital mutilation
  • History of prolapse or incontinence surgery
  • History of genital tract malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedStar Lafayette Center

Washington D.C., District of Columbia, 20036, United States

Location

Related Publications (10)

  • Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.

    PMID: 6226917BACKGROUND

  • Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018 Jan;4(1):18-24. doi: 10.1159/000477353. Epub 2017 Jul 6.

    PMID: 29457008RESULT

  • Kramer ME, Keaney TC. Systematic review of platelet-rich plasma (PRP) preparation and composition for the treatment of androgenetic alopecia. J Cosmet Dermatol. 2018 Oct;17(5):666-671. doi: 10.1111/jocd.12679. Epub 2018 May 22.

    PMID: 29790267RESULT

  • Xie X, Zhang C, Tuan RS. Biology of platelet-rich plasma and its clinical application in cartilage repair. Arthritis Res Ther. 2014 Feb 25;16(1):204. doi: 10.1186/ar4493.

    PMID: 25164150RESULT

  • Elghblawi E. Platelet-rich plasma, the ultimate secret for youthful skin elixir and hair growth triggering. J Cosmet Dermatol. 2018 Jun;17(3):423-430. doi: 10.1111/jocd.12404. Epub 2017 Sep 8.

    PMID: 28887865RESULT

  • Sukgen G, Ellibes Kaya A, Karagun E, Caliskan E. Platelet-rich plasma administration to the lower anterior vaginal wall to improve female sexuality satisfaction. Turk J Obstet Gynecol. 2019 Dec;16(4):228-234. doi: 10.4274/tjod.galenos.2019.23356. Epub 2020 Feb 28.

    PMID: 32231853RESULT

  • Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.

    PMID: 10782451RESULT

  • Derogatis LR, Rosen R, Leiblum S, Burnett A, Heiman J. The Female Sexual Distress Scale (FSDS): initial validation of a standardized scale for assessment of sexually related personal distress in women. J Sex Marital Ther. 2002 Jul-Sep;28(4):317-30. doi: 10.1080/00926230290001448.

    PMID: 12082670RESULT

  • Srikrishna S, Robinson D, Cardozo L. Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J. 2010 May;21(5):523-8. doi: 10.1007/s00192-009-1069-5. Epub 2009 Dec 15.

    PMID: 20013110RESULT

  • Wiegel M, Meston C, Rosen R. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther. 2005 Jan-Feb;31(1):1-20. doi: 10.1080/00926230590475206.

    PMID: 15841702RESULT

MeSH Terms

Conditions

Sexual Behavior

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Alexis Dieter, MD

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2023

First Posted

March 15, 2023

Study Start

August 18, 2023

Primary Completion

March 21, 2025

Study Completion

March 21, 2025

Last Updated

October 22, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)