An interventional study of Fractional CO₂ Laser and Autologous Platelet-Rich Plasma (PRP) in Genitourinary Syndrome of Menopause (GSM), sponsored by National and Kapodistrian University of Athens. Completed at 1 site in Greece. Open to female participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by National and Kapodistrian University of Athens · Not applicable, Interventional, and Treatment
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.
National and Kapodistrian University of Athens is the lead sponsor of 172 studies on the registry; 52 are open to participants now.
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Participants received 3 sessions of fractional CO₂ laser treatment at 4-6-week intervals for the management of genitourinary syndrome of menopause.
Device: Fractional CO₂ Laser
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.
Device: Fractional CO₂ Laser · Biological: Autologous Platelet-Rich Plasma (PRP)
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 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.
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.
Time frame: Baseline to 1 month after the final treatment session
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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 1 month after the final treatment session
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Platelet rich plasma
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