PRPNCT06028009
PRP Injections for Genitourinary Syndrome of Menopause
A study testing Injection of platelet-rich plasma and Injection of saline in people with PRP and Sexual Function Disturbances, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
Platelet-rich plasma (PRP) is autologous blood which has been centrifuged to separate the supernatant resulting in a solution with high concentration of platelets. Injection of PRP stimulates cell growth and can has been proven safe and effective for uses in orthopedics, dermatology, and gynecology. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- PRP, Sexual Function Disturbances, Genitourinary Syndrome of Menopause
- What is being tested?
- Injection of platelet-rich plasma and Injection of saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women (assigned female at birth) at least 18 years old with a clinical diagnosis of GSM
- Sexually active with at least one episode of sexual activity per week in the preceding 4 weeks defined as follows: Partnered or solo penetrative or non-penetrative stimulation of the clitoris or vagina
- English-speaking
- Willingness and able to comply with the study requirements
Who cannot join
- Symptomatic pelvic organ prolapse protruding beyond the hymen)
- History of prior vaginal mesh or midurethral mesh sling surgery
- History of pelvic radiation or genital tract malignancy
- Current symptomatic pelvic organ prolapse (stage II or greater)
- Active vulvar dermatoses or genitourinary infection
- Unable to hold anticoagulation
- Hormonal replacement therapy (systemic, local, or vaginal) within 3 months of participation
- Pregnancy or pre-menopausal status
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Lafayette Medical Centre
Washington D.C., District of Columbia, 20036
About this study
Official title: Vaginal Injection of Platelet Rich Plasma (PRP) for the Genitourinary Syndrome of Menopause (GSM)
Platelet-rich plasma (PRP) is autologous blood which has been centrifuged to separate the supernatant resulting in a solution with high concentration of platelets. Injection of PRP stimulates cell growth and can has been proven safe and effective for uses in orthopedics, dermatology, and gynecology. Despite the relative paucity of data, the use of PRP as a therapy for sexual dysfunction and genitourinary symptoms in the setting of menopause has been patented as the O-Shot and V-Shot. This is a single-blinded randomized control trial to determine if PRP injections into the anterior vaginal wall improve sexual functioning in women diagnosed with the genitourinary syndrome of menopause (GSM) characterized by vaginal dryness/irritation.
- Conditions
- PRP, Sexual Function Disturbances, Genitourinary Syndrome of Menopause, Postmenopausal Symptoms, Vaginal Atrophy
- Being tested
- Injection of platelet-rich plasma, Injection of saline
- Medical subject headings
- Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of platelet-rich plasmaProcedure or surgery
Injection of autologous platelet-rich plasma into anterior vaginal wall
Injection of salineProcedure or surgery
Injection of sterile normal saline into anterior vaginal wall
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich plasma injection | Experimental | Not described Receives: Procedure: Injection of platelet-rich plasma |
| 0.9% saline injection | Sham comparator | Not described Receives: Procedure: Injection of saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Index
Validated questionnaire to assess domains of sexual function with range from 2 to 36 with lower score indicating worse sexual functioning (diagnostic for sexual dysfunction if score is less than or equal to 26.55)
Measured: Assessed at baseline and at 6 weeks and 6 months post-procedure
Secondary outcomes (3)
Patient Global Impression of Improvement (PGI-I)
Single item questionnaire evaluating improvement in vaginal dryness with scale from 1 to 7 with lower score indicating greater improvement in vaginal dryness
Measured: Assessed at 6 weeks and 6 months post-intervention
Visual analog scale for vaginal dryness (VAS)
Visual analog scale for vaginal dryness (VAS) with range from 0 to 10 with higher score indicating higher degree of bothersome vaginal dryness
Measured: Assessed at 6 weeks and 6 months post-intervention
Urinary Distress Inventory (short form) (UDI-6)
6 item questionnaire assessing urinary symptoms with range from 0-18 with higher score indicating greater distress related to urinary symptoms
Measured: Assessed at baseline and 6 weeks/6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PRPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028009
- Sponsor's protocol ID
- STUDY00006805
- Status last verified
- Nov 2025
- First submitted
- 31 Aug 2023
- Last updated
- 14 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Injection of Platelet Rich Plasma (PRP) for the Genitourinary Syndrome of Menopause (GSM)
- ClinicalTrials.gov ID
- NCT06028009
- Acronym / sponsor ID
- STUDY00006805
- Conditions
- PRP, Sexual Function Disturbances, Genitourinary Syndrome of Menopause, Postmenopausal Symptoms, Vaginal Atrophy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Platelet-rich plasma (PRP) is autologous blood which has been centrifuged to separate the supernatant resulting in a solution with high concentration of platelets. Injection of PRP stimulates cell growth and can has been proven safe and effective for uses in orthopedics, dermatology, and gynecology. Despite the relative paucity of data, the use of PRP as a therapy for sexual dysfunction and genitourinary symptoms in the setting of menopause has been patented as the O-Shot and V-Shot. This is a single-blinded randomized control trial to determine if PRP injections into the anterior vaginal wall improve sexual functioning in women diagnosed with the genitourinary syndrome of menopause (GSM) characterized by vaginal dryness/irritation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich plasma injection | Experimental | Procedure: Injection of platelet-rich plasma |
| 0.9% saline injection | Sham comparator | Procedure: Injection of saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women (assigned female at birth) at least 18 years old with a clinical diagnosis of GSM
- Sexually active with at least one episode of sexual activity per week in the preceding 4 weeks defined as follows: Partnered or solo penetrative or non-penetrative stimulation of the clitoris or vagina
- English-speaking
- Willingness and able to comply with the study requirements
Key exclusion criteria (8 listed)
- Symptomatic pelvic organ prolapse protruding beyond the hymen)
- History of prior vaginal mesh or midurethral mesh sling surgery
- History of pelvic radiation or genital tract malignancy
- Current symptomatic pelvic organ prolapse (stage II or greater)
- Active vulvar dermatoses or genitourinary infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of platelet-rich plasmaInjection of autologous platelet-rich plasma into anterior vaginal wall | Procedure or surgery | Platelet-rich plasma injection |
| Injection of salineInjection of sterile normal saline into anterior vaginal wall | Procedure or surgery | 0.9% saline injection |
Primary outcome
Female Sexual Function Index
Time frame: Assessed at baseline and at 6 weeks and 6 months post-procedure
Validated questionnaire to assess domains of sexual function with range from 2 to 36 with lower score indicating worse sexual functioning (diagnostic for sexual dysfunction if score is less than or equal to 26.55)
3 secondary outcomes
Patient Global Impression of Improvement (PGI-I)
Time frame: Assessed at 6 weeks and 6 months post-intervention
Visual analog scale for vaginal dryness (VAS)
Time frame: Assessed at 6 weeks and 6 months post-intervention
Urinary Distress Inventory (short form) (UDI-6)
Time frame: Assessed at baseline and 6 weeks/6 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of platelet-rich plasma and Injection of saline in people with PRP and Sexual Function Disturbances, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (time frame: Assessed at baseline and at 6 weeks and 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.