Genitourinary Syndrome of Menopause (GSM)NCT07858994
Effects of Fractional CO2 Vaginal Laser in Postmenopausal Women With Genitourinary Syndrome of Menopause
A study testing Fractional CO2 Vaginal Laser in people with Genitourinary Syndrome of Menopause (GSM), run by Karina Amar Svec at 1 site in Brazil.
Trial summary
This study evaluated the effects of fractional carbon dioxide (CO2) vaginal laser treatment in postmenopausal women with genitourinary syndrome of menopause. Ten women underwent three fractional CO2 laser sessions at 30 to 40-day intervals. Read more about this study
- Who is it for?
- Ages 45 to 68 years, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause (GSM)
- What is being tested?
- Fractional CO2 Vaginal Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Nov 2023to 31 Jul 2025
- Phase
- Interventional
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 to 68 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one symptom of genitourinary syndrome of menopause, including vaginal dryness and/or itching, pain/burning, vulvar or vaginal burning, or dyspareunia
- Postmenopausal status, defined as at least 12 months of amenorrhea and confirmed by FSH ≥30 mIU/mL
- No oral or vaginal hormone therapy for at least 6 months
- Normal routine gynecological laboratory tests
- Recent normal cervical cytology
- Sexually active or wishing to be sexually active
Who cannot join
- More than 5 years since menopause
- Pregnancy
- Surgery for reconstruction of a narrowed vagina within the previous 12 months
- Current urinary tract infection
- Active vaginal infection
- Abnormal genital bleeding of unknown cause
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- Significant hormonal imbalance or severe chronic disease that could interfere with study outcomes
- Hot flashes
- Porphyria
- Current or previous history of thromboembolism
- Advanced stage II or III genital prolapse
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, 01221-020
About this study
Official title: Effects of Fractional CO2 Laser on Angiogenesis and Collagenesis in Women With Genitourinary Syndrome of Menopause
This study evaluated the effects of fractional carbon dioxide (CO2) vaginal laser treatment in postmenopausal women with genitourinary syndrome of menopause. Ten women underwent three fractional CO2 laser sessions at 30 to 40-day intervals. Clinical and vaginal assessments were performed before treatment and during follow-up. Vaginal tissue samples were collected at baseline, approximately one month after completion of treatment, and at long-term follow-up to evaluate histological changes, including collagen, vascularization, and estrogen receptor expression. Participants were followed through the long-term assessment performed approximately one year or more after treatment.
- Being tested
- Fractional CO2 Vaginal Laser
- Keywords
- Fractional CO2 Laser, Vaginal Laser, Postmenopause, Vaginal Atrophy, Estrogen Receptor, Collagen, Angiogenesis, Vaginal Histology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional CO2 Vaginal LaserDevice
Fractional microablative CO2 vaginal laser treatment was performed using the MTZ40 device with a 360-degree intravaginal probe. Treatment parameters were 28 W, pulse duration of 6.5 ms, and 45 DOTS. Participants received three treatment sessions at 30- to 40-day intervals. During each session, a single pass was performed along the vaginal walls, starting at the vaginal fornix and withdrawing the probe distally in 0.5-cm increments.
| Study group | Role | What they receive |
|---|---|---|
| Fractional CO2 Vaginal Laser | Experimental | Participants received three sessions of fractional CO2 vaginal laser treatment at 30- to 40-day intervals. Receives: Device: Fractional CO2 Vaginal Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estrogen Receptor Alpha (ERα) Expression in Vaginal Mucosa
ERα expression in vaginal mucosal tissue was assessed by immunohistochemistry and digital image analysis using QuPath. Nuclear staining was quantified as the percentage of ERα-positive cells and by H-score (range 0-300), calculated from the percentage of cells classified according to staining intensity (0, 1+, 2+, and 3+).
Measured: Baseline, 30 days after the third laser session, and long-term follow-up (median 17 months after the third laser session)
Microvascular Density Assessed by CD34 Immunostaining
Microvascular density in vaginal mucosal tissue was assessed by CD34 immunohistochemistry and semiautomated digital image analysis using Fiji/ImageJ. Microvascular density was quantified as the percentage of tissue area positive for CD34 immunostaining within standardized 0.45 mm² regions of interest.
Measured: Baseline, 30 days after the third laser session, and long-term follow-up (median 17 months after the third laser session)
Collagen Deposition in Vaginal Mucosa
Collagen deposition in vaginal mucosal tissue was assessed by Masson's trichrome staining and semiautomated digital image analysis using Fiji/ImageJ. Collagen deposition was quantified as the percentage of tissue area positive for collagen staining within standardized 0.45 mm² regions of interest.
Measured: Baseline, 30 days after the third laser session, and long-term follow-up (median 17 months after the third laser session)
Vaginal Epithelial Thickness
Vaginal epithelial thickness was assessed in hematoxylin-eosin (HE)-stained histological sections. It was measured as the maximum perpendicular distance between the basement membrane and the preserved epithelial surface and expressed in millimeters (mm).
Measured: Baseline, 30 days after the third laser session, and long-term follow-up (median 17 months after the third laser session)
Secondary outcomes (7)
Genitourinary Symptoms
Genitourinary symptoms were assessed using the Genital Atrophy Symptoms Questionnaire described by Lima et al. (2013). Six symptoms (vaginal dryness, itching, pain/soreness, burning, dyspareunia, and vaginal discharge) were each rated on a 4-point severity scale from 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The six item scores were summed to obtain a total score ranging from 0 to 18. Higher total scores indicate greater symptom severity.
Measured: Baseline; 30-40 days after the first laser session; 30-40 days after the second laser session; 30 days after the third laser session; and long-term follow-up (median 17 months after the third laser session)
Dyspareunia Assessed by Visual Analogue Scale (VAS)
Dyspareunia was assessed using a Visual Analogue Scale (VAS) ranging from 0 to 10, with higher scores indicating greater pain intensity.
Measured: Baseline, 30 days after the third laser session, and long-term follow-up (median 17 months after the third laser session)
Female Sexual Function Assessed by the Female Sexual Function Index (FSFI)
Female sexual function was assessed using the Female Sexual Function Index (FSFI), which evaluates six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The total FSFI score ranges from 2 to 36, with higher scores indicating better sexual function.
Measured: Baseline, 30 days after the third laser session, and long-term follow-up (median 17 months after the third laser session)
Quality of Life Assessed by the Short Form-36 Health Survey (SF-36)
Quality of life was assessed using the Short Form-36 Health Survey (SF-36), which evaluates eight health domains. Each domain is scored from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: Baseline, 30 days after the third laser session, and long-term follow-up (median 17 months after the third laser session)
Vaginal Health Assessed by the Vaginal Health Index Score (VHIS)
Vaginal health was assessed using the Vaginal Health Index Score (VHIS). The VHIS combines five components (vaginal elasticity, fluid volume, pH, epithelial integrity, and moisture), each scored from 1 to 5, into a single total score ranging from 5 to 25. Only the total VHIS is reported as the outcome measure. Higher total scores indicate better vaginal health.
Measured: Baseline, 30 days after the third laser session, and long-term follow-up (median 17 months after the third laser session)
Vaginal Maturation Assessed by Hormonal Cytology
Vaginal hormonal cytology was assessed using the Frost maturation index, based on the proportions of parabasal, intermediate, and superficial cells (P/I/S), expressed as percentages.
Measured: Baseline, 30 days after the third laser session, and long-term follow-up (median 17 months after the third laser session)
Participant Satisfaction With Treatment
Participant satisfaction with fractional CO2 vaginal laser treatment was assessed using a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) in response to the statement "I am satisfied with the treatment." Higher scores indicate greater satisfaction with treatment.
Measured: 30 days after the third laser session and long-term follow-up (median 17 months after the third laser session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start9 Nov 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karina Amar Svec
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karina Amar Svec, Karina Amar Svec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858994
- Sponsor's protocol ID
- SGUM-CO2-01
- Other IDs
- 60546222.0.0000.5479
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No