Genitourinary Syndrome of Menopause (GSM)NCT07863739
CO₂ Laser With or Without Platelet-Rich Plasma for Genitourinary Syndrome of Menopause
A study testing Fractional CO₂ Laser and Autologous Platelet-Rich Plasma (PRP) in people with Genitourinary Syndrome of Menopause (GSM), run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
This study evaluated whether adding platelet-rich plasma (PRP) to fractional CO₂ laser treatment provides additional benefit for postmenopausal women with genitourinary syndrome of menopause (GSM). Participants received either fractional CO₂ laser treatment alone or fractional CO₂ laser combined with PRP injections. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause (GSM)
- What is being tested?
- Fractional CO₂ Laser and Autologous Platelet-Rich Plasma (PRP)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jun 2023to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women, defined as more than 12 months of amenorrhea.
- Diagnosis of genitourinary syndrome of menopause (GSM).
- Vaginal dryness as the most bothersome GSM symptom.
- Inadequate response or intolerance to previous GSM therapies, unwillingness to use hormonal treatment, or contraindication to hormonal therapy.
- Ability and willingness to provide written informed consent and comply with the study protocol.
Who cannot join
- Use of systemic or local hormone therapy within 6 months before enrollment.
- Stage II or higher pelvic organ prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system.
- Active genital tract infection.
- History of gynecological or breast malignancy.
- Cervical dysplasia.
- Undiagnosed abnormal uterine bleeding.
- Significant chronic medical condition that could interfere with compliance with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fractional CO₂ Laser Versus Combined CO₂ Laser and Platelet-Rich Plasma for the Management of Genitourinary Syndrome of Menopause: A Prospective Study.
This study evaluated whether adding platelet-rich plasma (PRP) to fractional CO₂ laser treatment provides additional benefit for postmenopausal women with genitourinary syndrome of menopause (GSM). Participants received either fractional CO₂ laser treatment alone or fractional CO₂ laser combined with PRP injections. Both groups received three treatment sessions at 4-6-week intervals.
The main outcome was the change in vaginal dryness after treatment. Other outcomes included vaginal symptoms, sexual function, quality of life, and measures of vaginal health. The study also evaluated the safety and tolerability of both treatments.
- Being tested
- Fractional CO₂ Laser, Autologous Platelet-Rich Plasma (PRP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional CO₂ LaserDevice
Fractional laser treatment was performed using the DEKA DUOGlide GYN system (DEKA M.E.L.A., Florence, Italy), combining CO₂ (10,600 nm) and 1540 nm wavelengths. Three treatment sessions were performed at 4-6-week intervals.
Autologous Platelet-Rich Plasma (PRP)Biological
Autologous PRP was prepared from 40 mL of peripheral blood using the OMNIPLEX Gyno kit, yielding approximately 3 mL of PRP with a platelet concentration approximately nine times baseline. PRP was injected into predefined vaginal sites immediately after each laser treatment.
| Study group | Role | What they receive |
|---|---|---|
| Fractional CO₂ Laser | Active comparator | Participants received 3 sessions of fractional CO₂ laser treatment at 4-6-week intervals for the management of genitourinary syndrome of menopause. Receives: Device: Fractional CO₂ Laser |
| Fractional CO₂ Laser + Platelet-Rich Plasma | Experimental | Participants received 3 sessions of fractional CO₂ laser treatment followed by platelet-rich plasma (PRP) injections at 4-6-week intervals. PRP was administered immediately after each laser treatment. Receives: Device: Fractional CO₂ Laser; Biological: Autologous Platelet-Rich Plasma (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vaginal Dryness Severity
Vaginal dryness severity was assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no symptoms) to 10 (worst possible symptoms). Change from baseline was compared between the two treatment groups.
Measured: Baseline to 1 month after the final treatment session
Secondary outcomes (6)
Change in GSM Symptom Severity Assessed by Visual Analog Scale (VAS)
Dyspareunia, vaginal itching, burning, and dysuria were assessed separately using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no symptoms) to 10 (worst possible symptoms).
Measured: Baseline to 1 month after the final treatment session
Change in Female Sexual Function Index (FSFI) Score
Sexual function was assessed using the Female Sexual Function Index (FSFI), which evaluates six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Higher total scores indicate better sexual function.
Measured: Baseline to 1 month after the final treatment session
Change in Vaginal Health Index (VHI) Score
Vaginal health was assessed clinically using the Vaginal Health Index (VHI).
Measured: Baseline to 1 month after the final treatment session
Change in Vaginal Maturation Index (VMI)
Vaginal epithelial maturation was assessed by vaginal cytology based on the relative proportions of parabasal, intermediate, and superficial squamous cells.
Measured: Baseline to 1 month after the final treatment session
Change From Baseline in Vaginal pH
Vaginal pH was assessed using indicator strips with a measurement range of 4 to 7.
Measured: Baseline to 1 month after the final treatment session
Change From Baseline in Day-to-Day Impact of Vaginal Aging (DIVA) Score
The DIVA questionnaire was used to assess the impact of vaginal symptoms across four domains: activities of daily living, emotional well-being, sexual functioning, and self-concept/body image. Higher scores indicate greater impact of symptoms.
Measured: Baseline to 1 month after the final treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Jun 2023
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary Syndrome of Menopause (GSM)Studies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Themos Grigoriadis, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863739
- Sponsor's protocol ID
- 783/13-12-2022
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional CO₂ Laser Versus Combined CO₂ Laser and Platelet-Rich Plasma for the Management of Genitourinary Syndrome of Menopause: A Prospective Study.
- ClinicalTrials.gov ID
- NCT07863739
- Acronym / sponsor ID
- 783/13-12-2022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 7 Oct 2026 (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.
This study evaluated whether adding platelet-rich plasma (PRP) to fractional CO₂ laser treatment provides additional benefit for postmenopausal women with genitourinary syndrome of menopause (GSM). Participants received either fractional CO₂ laser treatment alone or fractional CO₂ laser combined with PRP injections. Both groups received three treatment sessions at 4-6-week intervals.
The main outcome was the change in vaginal dryness after treatment. Other outcomes included vaginal symptoms, sexual function, quality of life, and measures of vaginal health. The study also evaluated the safety and tolerability of both treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional CO₂ Laser | Active comparator | Device: Fractional CO₂ LaserParticipants received 3 sessions of fractional CO₂ laser treatment at 4-6-week intervals for the management of genitourinary syndrome of menopause. |
| Fractional CO₂ Laser + Platelet-Rich Plasma | Experimental | Device: Fractional CO₂ Laser, Biological: Autologous Platelet-Rich Plasma (PRP)Participants received 3 sessions of fractional CO₂ laser treatment followed by platelet-rich plasma (PRP) injections at 4-6-week intervals. PRP was administered immediately after each laser treatment. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal women, defined as more than 12 months of amenorrhea.
- Diagnosis of genitourinary syndrome of menopause (GSM).
- Vaginal dryness as the most bothersome GSM symptom.
- Inadequate response or intolerance to previous GSM therapies, unwillingness to use hormonal treatment, or contraindication to hormonal therapy.
- Ability and willingness to provide written informed consent and comply with the study protocol.
Key exclusion criteria (7 listed)
- Use of systemic or local hormone therapy within 6 months before enrollment.
- Stage II or higher pelvic organ prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system.
- Active genital tract infection.
- History of gynecological or breast malignancy.
- Cervical dysplasia.
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 |
|---|---|---|
| Fractional CO₂ LaserFractional laser treatment was performed using the DEKA DUOGlide GYN system (DEKA M.E.L.A., Florence, Italy), combining CO₂ (10,600 nm) and 1540 nm wavelengths. Three treatment sessions were performed at 4-6-week intervals. | Device | Fractional CO₂ Laser, Fractional CO₂ Laser + Platelet-Rich Plasma |
| Autologous Platelet-Rich Plasma (PRP)Autologous PRP was prepared from 40 mL of peripheral blood using the OMNIPLEX Gyno kit, yielding approximately 3 mL of PRP with a platelet concentration approximately nine times baseline. PRP was injected into predefined vaginal sites immediately after each laser treatment. | Biological | Fractional CO₂ Laser + Platelet-Rich Plasma |
Primary outcome
Change in Vaginal Dryness Severity
Time frame: Baseline to 1 month after the final treatment session
Vaginal dryness severity was assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no symptoms) to 10 (worst possible symptoms). Change from baseline was compared between the two treatment groups.
6 secondary outcomes
Change in GSM Symptom Severity Assessed by Visual Analog Scale (VAS)
Time frame: Baseline to 1 month after the final treatment session
Change in Female Sexual Function Index (FSFI) Score
Time frame: Baseline to 1 month after the final treatment session
Change in Vaginal Health Index (VHI) Score
Time frame: Baseline to 1 month after the final treatment session
Change in Vaginal Maturation Index (VMI)
Time frame: Baseline to 1 month after the final treatment session
Change From Baseline in Vaginal pH
Time frame: Baseline to 1 month after the final treatment session
Change From Baseline in Day-to-Day Impact of Vaginal Aging (DIVA) Score
Time frame: Baseline to 1 month after the final treatment session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- 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 Fractional CO₂ Laser and Autologous Platelet-Rich Plasma (PRP) in people with Genitourinary Syndrome of Menopause (GSM), run by National and Kapodistrian University of Athens at 1 site in Greece.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 8 Oct 2026. 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 Greece. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Vaginal Dryness Severity (time frame: Baseline to 1 month after the final treatment session). 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 8 Oct 2026.