Genitourinary Syndrome of MenopauseNCT06873971
Er:YAG Laser Combined With Vaginal Estriol for Genitourinary Syndrome of Menopause
A study testing Topical estrogen therapy based on estriol (E3) and Active Er:YAG Laser in people with Genitourinary Syndrome of Menopause, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Chronic hypoestrogenism in postmenopausal women significantly impacts the urogenital epithelium, leading to Genitourinary Syndrome of Menopause (GSM) and increasing susceptibility to gynecological infections due to vaginal pH elevation. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genitourinary Syndrome of Menopause
- What is being tested?
- Topical estrogen therapy based on estriol (E3) and Active Er:YAG Laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Dec 2025to 31 Dec 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 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women (45-70 years of age).
- At least one of moderate symptom of GSM (vaginal dryness, burning sensation, dyspareunia, and persistent leukorrhea), defined by ≥ 4 on Visual Analog Scale (VAS) ranging from 0 to 10.
- Vaginal pH ≥5.0 at baseline assessment.
- Not having undergone hormone replacement therapy (vaginal or systemic) in the previous six months.
- No use of vaginal moisturizers in the previous 30 days.
- Demonstrated capacity and willingness to provide written informed consent and adhere to study protocols.
Who cannot join
- Vaginal or vulvar energy-based interventions (e.g., laser, radiofrequency) in the previous six months.
- Abnormal cervical cytology, specifically ASCUS, LSIL, or HSIL, documented in the previous six months.
- Systemic corticosteroid therapy administered in the previous 90 days.
- Body mass index (BMI) ≥35 kg/m².
- Presence of abnormal uterine bleeding in the previous 30 days.
- History of vaginal surgery in the previous 180 days or grade II or higher uterine prolapse (POP-q).
- History of malignant neoplasms or exposure to vaginal radiotherapy.
- Diagnosis of severe liver or kidney disease, autoimmune disease, or severe psychiatric disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Nove de Julho
São Paulo, São Paulo, 01525-000
Stella Regina Zamuner, pHD, MD, +551133859241, stella.rz@uni9.pro.br
About this study
Official title: Effects of Erbium:YAG Laser Combined With Vaginal Estriol Therapy in Postmenopausal Women With Genitourinary Syndrome of Menopause: A Protocol for a Randomised, Double-blind Controlled Trial
Chronic hypoestrogenism in postmenopausal women significantly impacts the urogenital epithelium, leading to Genitourinary Syndrome of Menopause (GSM) and increasing susceptibility to gynecological infections due to vaginal pH elevation. Therapies using the Erbium:YAG (Er:YAG) 2940nm laser and low dose topical estrogen have demonstrated efficacy in improving vaginal trophism and restoring microbiota balance.
This randomised, double-blind clinical study aims to assess the effects of combining Er: YAG laser therapy with vaginal estriol compared with estriol therapy alone in postmenopausal women with GSM. Sixty patients will be recruited and randomly assigned to two groups. All participants will receive low-dose topical estrogen therapy (estriol cream ) for 14 days, followed by twice-weekly applications until completing three laser sessions at four-week intervals. Group 1 (Sham) will receive the laser with minimal fluence (0.5J/cm²) applied to maintain blinding (auditory cues) below the threshold for biological tissue, while Group 2 , will undergo active laser treatment.
Read more
Inclusion criteria include age 45-70 years, vaginal pH ≥5, absence of hormone therapy or energy-based intimate treatments for 180 days, and moderate vaginal atrophy symptoms (SCORE >4). Exclusion criteria include abnormal cervicalvaginal cytology in the last six months, corticosteroid therapy within 90 days, and BMI ≥35kg/m².
Assessments will occur at Baseline, 30 days after each laser session and 4 months after the third laser application. The primary outcome is the Vaginal Health Index (VHI), while secondary outcomes include GSM symptom evaluation via the Visual Analog Scale, vaginal microbiota analysis through 16S gene sequencing, and quality-of-life and sexual health questionnaires. Statistical analysis of the groups will be performed using SPSS version 22.0. For analytical statistics, repeated measures ANOVA will be used for continuous data, and non-parametric tests for repeated measures, such as the Friedman test, when appropriate. A p-value <0.05 will be considered statistically significant.
Read the detailed description
Chronic, progressive hypoestrogenism, without adequate treatment during the postmenopausal period, significantly affects the epithelium of the urogenital system, causing Genitourinary Syndrome of Menopause (GSM). This disorder impacts the quality of life of thousands of women, favoring the emergence of other pathologies, including increasing the risk of gynecological infections from opportunistic microorganisms due to the elevation of vaginal pH, destabilizing the natural immunological barrier. Therapies using the Erbium:YAG (Er:YAG) 2940nm laser and low-dose topical estrogen therapy have demonstrated safety and efficacy in improving vaginal trophism, being crucial for the reestablishment of appropriate flora.
This study aims to assess the effects of combining Er: YAG laser therapy with vaginal estriol compared with estriol therapy alone in postmenopausal women with GSM. This is a randomised, double-blind clinical study. Sixty patients will be recruited and randomly divided into two groups. All participants will receive low-dose topical estrogen therapy (vaginal estriol cream (1 mg/g) administered intravaginally using disposable applicators pre-set to deliver 0.5 g per application (equivalent to 0.5 mg of estriol per dose) for 14 consecutive days and then twice weekly until completing three sessions of laser treatment, with a 4-week interval between sessions. In Group 1 (Sham), the laser will be applied with minimal fluence (0.5 J/cm²) to maintain blinding (auditory cues) below the threshold for biological tissue, while in Group 2, will be applied an active Er:YAG laser intervention. The intimate laser session consists of two stages: the internal stage ( vaginal canal) with energy settings of 9J/cm² at 2Hz and the external stage (vulvar and vestibule region) with energy settings of 6J/cm² at 2Hz.
Inclusion criteria include age between 45 and 70 years, vaginal pH level ≥5, absence of hormone therapy and intimate treatments using energy for 180 days, and presence of moderate symptoms of vaginal atrophy (SCORE >4). Exclusion criteria include altered cervical-vaginal cytology in the last six months, corticosteroid therapy within the last 90 days, and BMI ≥35kg/m².
The Vulvovaginal Health Index (VHI) is defined as the primary outcome of this study. Secondary outcomes will include the Visual Analog Scale for four symptoms of GSM (burning, irritation, dyspareunia, and persistent leukorrhea), vaginal microbiological sampling for DNA sequencing analysis using the 16S gene amplification technique, specifically at the V3/V4 region (before the first laser therapy session and 4 weeks after the third application), quality of life, and sexual health questionnaires.
Comparisons between the two groups will be conducted at Baseline, 30 days after each laser session and 4 months after the third laser application. Although data will be collected at multiple time points using validated instruments and laboratory assessments, the primary analysis will focus on predefined time points. Specifically, comparisons will be conducted between baseline and two post-intervention time points: (1) at the third laser session and (2) at follow-up, defined as four months after the third laser session.
Data will be collected using coded identifiers and stored on a secure, password-protected institutional server with restricted access. Regular data back-ups will be performed. Access to identifiable data will be limited to authorised members of the research team. De-identified data will be made available upon reasonable request, subject to appropriate ethical approval and the completion of a data sharing agreement. Further details are available via the study repository on the Open Science Framework (OSF): https://osf.io/dwgvx/.
Statistical analysis of the groups will be performed using SPSS version 22.0. For analytical statistics, repeated measures ANOVA will be used for continuous data, and non-parametric tests for repeated measures, such as the Friedman test, when appropriate. A p-value <0.05 will be considered statistically significant.
- Conditions
- Genitourinary Syndrome of Menopause
- Being tested
- Topical estrogen therapy based on estriol (E3), Active Er:YAG Laser, Sham Er:YAG laser (minimal fluence)
- Keywords
- Genitourinary syndrome of menopause, postmenopausal women, Erbium: YAG laser, vaginal microbiome, vaginal estriol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical estrogen therapy based on estriol (E3)Drug
Also called Estriol ( E3), Vaginal estriol ( E3)
All participants will use low-dose Vaginal estriol cream (1 mg/g) administered intravaginally using disposable, individualized vaginal applicators pre-set at the recommended dosage of 0.5g/ per application (equivalent to 0.5 mg of estriol per dose).
Induction phase: 0.5 g once daily at bedtime for 14 consecutive days. Maintenance phase: 0.5 g twice weekly for 16 weeks, on Mondays and Thursdays. The treatment will be provided in fractions for each 30 day period and will always be delivered after each laser session, along with a leaflet containing usage, storage, and application instructions for the vaginal cream. The patients will be monitored through a messaging app, reinforcing the instructions and the days of application correctly.
Active Er:YAG LaserRadiation
Also called Laser On, Laser in Active Intervention Mode
All participants in the group will undergo 3 applications of active Er:YAG laser with an interval of 4-5 weeks between them. The intimate laser session consists of two stages using a PS03 fractional tip: the internal stage (vaginal canal) with energy settings of 9 J/cm² at 2 Hz, and the external stage (vulvar and vestibule region) with energy settings of 6 J/cm² at 2 Hz.The laser device to be used is the Smooth XS Dynamics Dualis (FOTONA, Ljubljana, Slovenia) with a wavelength of 2940 nm.
Sham Er:YAG laser (minimal fluence)Radiation
Also called Laser in Minimal Fluence
All participants in the group will undergo 3 sham applications of Sham Er:YAG laser intervention delivered at minimal fluence (0.5 J), below the threshold for biological tissue effect, applied to preserve participant blinding through auditory and procedural cues , with an interval of 4-5 weeks between them. The intimate laser session consists of two stages using a PS03 fractional tip: the internal stage (vaginal canal) with energy settings of 0.5 J/cm² at 2 Hz, and the external stage (vestibule and introitus region) with energy settings of 0.5 J/cm² at 2 Hz.The laser device to be used is the Smooth XS Dynamics Dualis (FOTONA, Ljubljana, Slovenia) with a wavelength of 2940 nm.
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 (Vaginal estriol plus Sham Er:YAG laser (minimal fluence)) | Sham comparator | All participants will receive vaginal estriol therapy combined with Er:YAG laser intervention with minimal fluence (0.5 J/cm²), below the therapeutic range reported for GSM, and not expected to induce clinically meaningful tissue effects, applied to maintain participant blinding through auditory and procedural cue. Participants will undergo three laser applications at four-week intervals. The intimate laser session consists of two stages using a PS03 fractional tip: the internal stage (vaginal canal) with energy settings of 0.5 J/cm² at 2 Hz, and the external stage (vulvar and vestibule region) with energy settings of 0.5J/cm² at 2 Hz. Receives: Drug: Topical estrogen therapy based on estriol (E3); Radiation: Sham Er:YAG laser (minimal fluence) |
| GROUP 2 ( Vaginal estriol plus active Er:YAG laser) | Active comparator | All participants will receive vaginal estriol therapy combined with an active Er:YAG (λ = 2940 nm) . Participants will undergo three laser applications at four-week intervals. The intimate laser session consists of two stages using a PS03 fractional tip: the internal stage (vaginal canal) with energy settings of 9 J/cm² at 2 Hz, and the external stage (vulvar and vestibule region with energy settings of 6 J/cm² at 2 Hz.The laser device to be used is the Smooth XS Dynamics Dualis (FOTONA, Ljubljana, Slovenia) with a wavelength of 2940 nm. Receives: Drug: Topical estrogen therapy based on estriol (E3); Radiation: Active Er:YAG Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the Vaginal Health Index (VHI)
Clinically assesses the degree of genital atrophy through physical examination, which analyzes "urogenital health." This is useful for the longitudinal follow-up of patients, where changes occurring in the genitourinary tract are noted, including the analysis of the need for therapeutic intervention. The parameters analyzed are: total elasticity, type and consistency of fluid secretion, Vaginal pH, epithelial mucosa, and moisture, which, according to their characteristics, receive scores from 1 to 5. The lower the score, the greater the degree of urogenital atrophy.
Vaginal pH will be assessed as an integral component of the Vaginal Health Index and will not be analysed as a separate outcome measure.
Measured: Baseline, 30 days after each laser session and 4 months after the third laser application.
Secondary outcomes (4)
Vaginal Microbiome
The analytical methodology involves sequencing the 16S rRNA gene (V3/V4) after DNA extraction using the "ZymoBIOMICS DNA Miniprep" kit, following the manufacturer's guidelines provided by "Biomehub Research and Development S.A." For bacterial identification, library preparation will be performed through amplification of the V3/V4 regions (341F and 806R) using a two-step PCR. The first PCR employs universal oligonucleotides for the V3/V4 region, while the second incorporates sequencing indexes. Sample collection will be conducted individually by the responsible researcher before the first laser session and four weeks after the third application. Statistical evaluations will include descriptive analysis, alpha diversity, beta diversity, and differential abundance between groups. Samples will be stored for three months and subsequently discarded by the contracted laboratory, adhering to the manufacturer's recommendations.
Measured: Before first laser session and four weeks after the third laser application.
Visual Analog Scale (VAS)
Four types of symptoms of GSM (dryness, burning, dyspareunia, and chronic leukorrhea) will be evaluated separately by the patient according to the VAS criteria, ranging from 0 (absence of symptoms) to 10 (very severe symptoms). Moderate symptoms will be considered with values equal to or greater than 4.
Measured: baseline, 30 days after each laser session and four months after the third laser application
Quality of Life Evaluation Questionnaires: Menopause Rating Scale (MRS)
Used to assess quality of life and symptoms related to climacteric. It consists of 11 questions distributed to analyze three parameters: somato-vegetative symptoms, psychological symptoms, and urogenital symptoms, which are classified into five degrees: none, mild, moderate, severe, and extremely severe. The higher the score, the greater the severity of the symptoms and, consequently, the worse the quality of life for the woman during the climacteric.
Measured: Baseline, 30 days after each laser session and 4 months after the third laser application.
Female Sexual Function Index (FSFI)
A tool used to evaluate female sexual response, based on the analysis of six domains: sexual desire, sexual arousal, vaginal lubrication, orgasm, sexual satisfaction, and pain. This assists in understanding how various factors, including health, relationships, and psychosocial factors, influence sexual satisfaction.
Measured: Baseline, 30 days after each laser session and 4 months after the third laser application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start10 Dec 2025
- Primary completion10 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genitourinary Syndrome of MenopauseStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stella Regina Zamuner, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873971
- Sponsor's protocol ID
- ERBIUM-YAG-LASER
- Status last verified
- Apr 2026
- First submitted
- 21 Feb 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in this study, after de-identification, will be shared upon reasonable request. Supporting documents, including the study protocol, statistical analysis plan, and analytic code, will also be made available.
Publications
Souza MCDCD, de Jarmy-Di Bella ZIK, Bianchi-Ferraro AMHM, Souza SDL, Amanda Rafaelly Honorio M, Sobral APT, Ribeiro CDPV, Bussadori SK, Fernandes KPS, Chavantes MC, Zamuner SR. Effects of Erbium:YAG laser combined with vaginal estriol therapy in postmenopausal women with Genitourinary Syndrome of Menopause: protocol for a randomised, double-blind, controlled trial. BMJ Open. 2026 Jun 11;16(6):e117269. doi: 10.1136/bmjopen-2026-117269.
PubMed 42276807
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Erbium:YAG Laser Combined With Vaginal Estriol Therapy in Postmenopausal Women With Genitourinary Syndrome of Menopause: A Protocol for a Randomised, Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT06873971
- Acronym / sponsor ID
- ERBIUM-YAG-LASER
- Conditions
- Genitourinary Syndrome of Menopause
- Keywords
- Genitourinary syndrome of menopause, postmenopausal women, Erbium: YAG laser, vaginal microbiome, vaginal estriol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Mar 2025 (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.
Chronic hypoestrogenism in postmenopausal women significantly impacts the urogenital epithelium, leading to Genitourinary Syndrome of Menopause (GSM) and increasing susceptibility to gynecological infections due to vaginal pH elevation. Therapies using the Erbium:YAG (Er:YAG) 2940nm laser and low dose topical estrogen have demonstrated efficacy in improving vaginal trophism and restoring microbiota balance.
This randomised, double-blind clinical study aims to assess the effects of combining Er: YAG laser therapy with vaginal estriol compared with estriol therapy alone in postmenopausal women with GSM. Sixty patients will be recruited and randomly assigned to two groups. All participants will receive low-dose topical estrogen therapy (estriol cream ) for 14 days, followed by twice-weekly applications until completing three laser sessions at four-week intervals. Group 1 (Sham) will receive the laser with minimal fluence (0.5J/cm²) applied to maintain blinding (auditory cues) below the threshold for biological tissue, while Group 2 , will undergo active laser treatment.
Inclusion criteria include age 45-70 years, vaginal pH ≥5, absence of hormone therapy or energy-based intimate treatments for 180 days, and moderate vaginal atrophy symptoms (SCORE >4). Exclusion criteria include abnormal cervicalvaginal cytology in the last six months, corticosteroid therapy within 90 days, and BMI ≥35kg/m².
Assessments will occur at Baseline, 30 days after each laser session and 4 months after the third laser application. The primary outcome is the Vaginal Health Index (VHI), while secondary outcomes include GSM symptom evaluation via the Visual Analog Scale, vaginal microbiota analysis through 16S gene sequencing, and quality-of-life and sexual health questionnaires. Statistical analysis of the groups will be performed using SPSS version 22.0. For analytical statistics, repeated measures ANOVA will be used for continuous data, and non-parametric tests for repeated measures, such as the Friedman test, when appropriate. A p-value <0.05 will be considered statistically significant.
Detailed description
Chronic, progressive hypoestrogenism, without adequate treatment during the postmenopausal period, significantly affects the epithelium of the urogenital system, causing Genitourinary Syndrome of Menopause (GSM). This disorder impacts the quality of life of thousands of women, favoring the emergence of other pathologies, including increasing the risk of gynecological infections from opportunistic microorganisms due to the elevation of vaginal pH, destabilizing the natural immunological barrier. Therapies using the Erbium:YAG (Er:YAG) 2940nm laser and low-dose topical estrogen therapy have demonstrated safety and efficacy in improving vaginal trophism, being crucial for the reestablishment of appropriate flora.
This study aims to assess the effects of combining Er: YAG laser therapy with vaginal estriol compared with estriol therapy alone in postmenopausal women with GSM. This is a randomised, double-blind clinical study. Sixty patients will be recruited and randomly divided into two groups. All participants will receive low-dose topical estrogen therapy (vaginal estriol cream (1 mg/g) administered intravaginally using disposable applicators pre-set to deliver 0.5 g per application (equivalent to 0.5 mg of estriol per dose) for 14 consecutive days and then twice weekly until completing three sessions of laser treatment, with a 4-week interval between sessions. In Group 1 (Sham), the laser will be applied with minimal fluence (0.5 J/cm²) to maintain blinding (auditory cues) below the threshold for biological tissue, while in Group 2, will be applied an active Er:YAG laser intervention. The intimate laser session consists of two stages: the internal stage ( vaginal canal) with energy settings of 9J/cm² at 2Hz and the external stage (vulvar and vestibule region) with energy settings of 6J/cm² at 2Hz.
Inclusion criteria include age between 45 and 70 years, vaginal pH level ≥5, absence of hormone therapy and intimate treatments using energy for 180 days, and presence of moderate symptoms of vaginal atrophy (SCORE >4). Exclusion criteria include altered cervical-vaginal cytology in the last six months, corticosteroid therapy within the last 90 days, and BMI ≥35kg/m².
The Vulvovaginal Health Index (VHI) is defined as the primary outcome of this study. Secondary outcomes will include the Visual Analog Scale for four symptoms of GSM (burning, irritation, dyspareunia, and persistent leukorrhea), vaginal microbiological sampling for DNA sequencing analysis using the 16S gene amplification technique, specifically at the V3/V4 region (before the first laser therapy session and 4 weeks after the third application), quality of life, and sexual health questionnaires.
Comparisons between the two groups will be conducted at Baseline, 30 days after each laser session and 4 months after the third laser application. Although data will be collected at multiple time points using validated instruments and laboratory assessments, the primary analysis will focus on predefined time points. Specifically, comparisons will be conducted between baseline and two post-intervention time points: (1) at the third laser session and (2) at follow-up, defined as four months after the third laser session.
Data will be collected using coded identifiers and stored on a secure, password-protected institutional server with restricted access. Regular data back-ups will be performed. Access to identifiable data will be limited to authorised members of the research team. De-identified data will be made available upon reasonable request, subject to appropriate ethical approval and the completion of a data sharing agreement. Further details are available via the study repository on the Open Science Framework (OSF): https://osf.io/dwgvx/.
Statistical analysis of the groups will be performed using SPSS version 22.0. For analytical statistics, repeated measures ANOVA will be used for continuous data, and non-parametric tests for repeated measures, such as the Friedman test, when appropriate. A p-value <0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 (Vaginal estriol plus Sham Er:YAG laser (minimal fluence)) | Sham comparator | Drug: Topical estrogen therapy based on estriol (E3), Radiation: Sham Er:YAG laser (minimal fluence)All participants will receive vaginal estriol therapy combined with Er:YAG laser intervention with minimal fluence (0.5 J/cm²), below the therapeutic range reported for GSM, and not expected to induce clinically meaningful tissue effects, applied to maintain participant blinding through auditory and procedural cue. Participants will undergo three laser applications at four-week intervals. The intimate laser session consists of two stages using a PS03 fractional tip: the internal stage (vaginal canal) with energy settings of 0.5 J/cm² at 2 Hz, and the external stage (vulvar and vestibule region) with energy settings of 0.5J/cm² at 2 Hz. |
| GROUP 2 ( Vaginal estriol plus active Er:YAG laser) | Active comparator | Drug: Topical estrogen therapy based on estriol (E3), Radiation: Active Er:YAG LaserAll participants will receive vaginal estriol therapy combined with an active Er:YAG (λ = 2940 nm) . Participants will undergo three laser applications at four-week intervals. The intimate laser session consists of two stages using a PS03 fractional tip: the internal stage (vaginal canal) with energy settings of 9 J/cm² at 2 Hz, and the external stage (vulvar and vestibule region with energy settings of 6 J/cm² at 2 Hz.The laser device to be used is the Smooth XS Dynamics Dualis (FOTONA, Ljubljana, Slovenia) with a wavelength of 2940 nm. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Postmenopausal women (45-70 years of age).
- At least one of moderate symptom of GSM (vaginal dryness, burning sensation, dyspareunia, and persistent leukorrhea), defined by ≥ 4 on Visual Analog Scale (VAS) ranging from 0 to 10.
- Vaginal pH ≥5.0 at baseline assessment.
- Not having undergone hormone replacement therapy (vaginal or systemic) in the previous six months.
- No use of vaginal moisturizers in the previous 30 days.
Key exclusion criteria (8 listed)
- Vaginal or vulvar energy-based interventions (e.g., laser, radiofrequency) in the previous six months.
- Abnormal cervical cytology, specifically ASCUS, LSIL, or HSIL, documented in the previous six months.
- Systemic corticosteroid therapy administered in the previous 90 days.
- Body mass index (BMI) ≥35 kg/m².
- Presence of abnormal uterine bleeding in the previous 30 days.
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 |
|---|---|---|
| Topical estrogen therapy based on estriol (E3)Also: Estriol ( E3), Vaginal estriol ( E3)All participants will use low-dose Vaginal estriol cream (1 mg/g) administered intravaginally using disposable, individualized vaginal applicators pre-set at the recommended dosage of 0.5g/ per application (equivalent to 0.5 mg of estriol per dose). Induction phase: 0.5 g once daily at bedtime for 14 consecutive days. Maintenance phase: 0.5 g twice weekly for 16 weeks, on Mondays and Thursdays. The treatment will be provided in fractions for each 30 day period and will always be delivered after each laser session, along with a leaflet containing usage, storage, and application instructions for the vaginal cream. The patients will be monitored through a messaging app, reinforcing the instructions and the days of application correctly. | Drug | GROUP 1 (Vaginal estriol plus Sham Er:YAG laser (minimal fluence)), GROUP 2 ( Vaginal estriol plus active Er:YAG laser) |
| Active Er:YAG LaserAlso: Laser On, Laser in Active Intervention ModeAll participants in the group will undergo 3 applications of active Er:YAG laser with an interval of 4-5 weeks between them. The intimate laser session consists of two stages using a PS03 fractional tip: the internal stage (vaginal canal) with energy settings of 9 J/cm² at 2 Hz, and the external stage (vulvar and vestibule region) with energy settings of 6 J/cm² at 2 Hz.The laser device to be used is the Smooth XS Dynamics Dualis (FOTONA, Ljubljana, Slovenia) with a wavelength of 2940 nm. | Radiation | GROUP 2 ( Vaginal estriol plus active Er:YAG laser) |
| Sham Er:YAG laser (minimal fluence)Also: Laser in Minimal FluenceAll participants in the group will undergo 3 sham applications of Sham Er:YAG laser intervention delivered at minimal fluence (0.5 J), below the threshold for biological tissue effect, applied to preserve participant blinding through auditory and procedural cues , with an interval of 4-5 weeks between them. The intimate laser session consists of two stages using a PS03 fractional tip: the internal stage (vaginal canal) with energy settings of 0.5 J/cm² at 2 Hz, and the external stage (vestibule and introitus region) with energy settings of 0.5 J/cm² at 2 Hz.The laser device to be used is the Smooth XS Dynamics Dualis (FOTONA, Ljubljana, Slovenia) with a wavelength of 2940 nm. | Radiation | GROUP 1 (Vaginal estriol plus Sham Er:YAG laser (minimal fluence)) |
Primary outcome
Analysis of the Vaginal Health Index (VHI)
Time frame: Baseline, 30 days after each laser session and 4 months after the third laser application.
Clinically assesses the degree of genital atrophy through physical examination, which analyzes "urogenital health." This is useful for the longitudinal follow-up of patients, where changes occurring in the genitourinary tract are noted, including the analysis of the need for therapeutic intervention. The parameters analyzed are: total elasticity, type and consistency of fluid secretion, Vaginal pH, epithelial mucosa, and moisture, which, according to their characteristics, receive scores from 1 to 5. The lower the score, the greater the degree of urogenital atrophy. Vaginal pH will be assessed as an integral component of the Vaginal Health Index and will not be analysed as a separate outcome measure.
4 secondary outcomes
Vaginal Microbiome
Time frame: Before first laser session and four weeks after the third laser application.
Visual Analog Scale (VAS)
Time frame: baseline, 30 days after each laser session and four months after the third laser application
Quality of Life Evaluation Questionnaires: Menopause Rating Scale (MRS)
Time frame: Baseline, 30 days after each laser session and 4 months after the third laser application.
Female Sexual Function Index (FSFI)
Time frame: Baseline, 30 days after each laser session and 4 months after the third laser application.
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 23 Apr 2026.
- Derived from this study: PubMed 42276807Souza MCDCD, de Jarmy-Di Bella ZIK, Bianchi-Ferraro AMHM, Souza SDL, Amanda Rafaelly Honorio M, Sobral APT, Ribeiro CDPV, Bussadori SK, Fernandes KPS, Chavantes MC, Zamuner SR. Effects of Erbium:YAG laser combined with vaginal estriol therapy in postmenopausal women with Genitourinary Syndrome of Menopause: protocol for a randomised, double-blind, controlled trial. BMJ Open. 2026 Jun 11;16(6):e117269. doi: 10.1136/bmjopen-2026-117269.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in this study, after de-identification, will be shared upon reasonable request. Supporting documents, including the study protocol, statistical analysis plan, and analytic code, will also be made available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical estrogen therapy based on estriol (E3) and Active Er:YAG Laser in people with Genitourinary Syndrome of Menopause, run by University of Nove de Julho at 1 site in Brazil.
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 6 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: looking for participants now, as of the sponsor's last update on 23 Apr 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 Brazil. 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?
Contact Stella Zamuner (+55 11 3385-9241, stella.rz@uni9.pro.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the Vaginal Health Index (VHI) (time frame: Baseline, 30 days after each laser session and 4 months after the third laser application.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06873971, which also lists 1 linked publication.
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 23 Apr 2026.