Genitourinary Syndrome of MenopauseATROVENANSNCT05151380
Clinical and Cyto-histological Evaluation of Fractional CO2 Laser Treatment on Genito-Urinary Syndromes of Menopause Related to Vaginal Atrophy
A study testing CO2 laser MonaLisa Touch ® in people with Genitourinary Syndrome of Menopause, run by Hopital Nord Franche-Comte at 1 site in France.
Trial summary
Estrogen deficiency can occur naturally during menopause or as a secondary effect of various treatments for breast or pelvic cancer and can lead to very disabling vulvovaginal symptoms, since it is associated with an anatomical and functional cellular modification of the urogenital sphere. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause
- What is being tested?
- CO2 laser MonaLisa Touch ®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2021to 10 Nov 2023
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over 40 years of age
- Patients with natural menopause or menopause secondary to cancer treatment (breast, pelvis or other)
- Patients with vaginal and/or urinary, non-vulvar GSM
- Patients for whom CO2 laser therapy is proposed
Who cannot join
- Vulvovaginal infections (vaginosis)
- Uninvestigated vaginal hemorrhage
- Herpes
- Pregnancy or breastfeeding
- Cervico-vaginal pathology (cervical and/or vaginal dysplasia)
- Suspected or diagnosed HPV
- Significant vaginal prolapse
- Patients on hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Clinique Et Cyto-histologique Du Traitement Laser CO2 Fractionné Sur Les Syndromes Génito-Urinaires De La Ménopause Liés À L'atrophie Vaginale
Estrogen deficiency can occur naturally during menopause or as a secondary effect of various treatments for breast or pelvic cancer and can lead to very disabling vulvovaginal symptoms, since it is associated with an anatomical and functional cellular modification of the urogenital sphere. These changes result in urogenital atrophy responsible for vaginal dryness, painful intercourse (dyspareunia), discomfort, itching and burning sensations, dysuria, urgency and incontinence. These symptoms, which significantly affect quality of life, are found in more than 40% of menopausal women and are grouped under the term Genitourinary Syndrome of Menopause (GSM). General or local estrogen-based treatments improve patients' symptoms, but remain contraindicated in women who have had breast cancer. Non-estrogenic local treatments are less effective, remain restrictive and are therefore often abandoned.
The CO2 laser is currently part of the therapeutic arsenal for the management of patients with GSM. This device prevents and eliminates the effects of low estrogen levels on vaginal tissue by restoring the characteristic conditions of the vaginal mucosa of a woman of childbearing age. This simple treatment, which lasts only a few minutes, is safe and painless and has no serious side effects. It restores the tone and elasticity of the tissues, with positive effects on the quality of life and the couple's relationship. The investigators wish to evaluate the possible changes of the genital sphere in a longitudinal way (before, during and after the treatment), including the induced cytohistological changes, in patients with GSM who can benefit of this therapy.
- Conditions
- Genitourinary Syndrome of Menopause
- Being tested
- CO2 laser MonaLisa Touch ®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 laser MonaLisa Touch ®Device
3 sessions of SmartXide fractional CO2 laser via the MonaLisa Touch® device, spaced 4 weeks apart, will be performed. An additional comfort session will be performed at 1 year if needed.
The handpiece of the MonaLisa Touch® device is applied to the vaginal walls with a 360° scan, between 800 and 1100µs, to the vaginal orifice
| Study group | Role | What they receive |
|---|---|---|
| Women with CO2 laser MonaLisa Touch ® sessions | Other | Women with 3 sessions of CO2 laser MonaLisa Touch ® Receives: Device: CO2 laser MonaLisa Touch ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective of the study is to analyze the evolution of GSM by the use of the MonaLisa Touch ® fractionated laser.
The primary endpoint is the comparison of the patient's clinical score composed of a visual analogic scale measuring the intensity of symptoms related to vaginal atrophy (i.e., vaginal burning, vaginal pruritus, vaginal dryness, dyspareunia, and dysuria), before and after 3 laser sessions.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start9 Dec 2021
- Primary completion11 Sep 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Nord Franche-Comte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151380
- Sponsor's protocol ID
- 2021-A01625-36
- Acronym
- ATROVENANS
- Status last verified
- Dec 2024
- First submitted
- 26 Nov 2021
- Last updated
- 27 Dec 2024
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Clinique Et Cyto-histologique Du Traitement Laser CO2 Fractionné Sur Les Syndromes Génito-Urinaires De La Ménopause Liés À L'atrophie Vaginale
- ClinicalTrials.gov ID
- NCT05151380
- Acronym / sponsor ID
- ATROVENANS / 2021-A01625-36
- Conditions
- Genitourinary Syndrome of Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hopital Nord Franche-ComteUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 9 Dec 2021 (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.
Estrogen deficiency can occur naturally during menopause or as a secondary effect of various treatments for breast or pelvic cancer and can lead to very disabling vulvovaginal symptoms, since it is associated with an anatomical and functional cellular modification of the urogenital sphere. These changes result in urogenital atrophy responsible for vaginal dryness, painful intercourse (dyspareunia), discomfort, itching and burning sensations, dysuria, urgency and incontinence. These symptoms, which significantly affect quality of life, are found in more than 40% of menopausal women and are grouped under the term Genitourinary Syndrome of Menopause (GSM). General or local estrogen-based treatments improve patients' symptoms, but remain contraindicated in women who have had breast cancer. Non-estrogenic local treatments are less effective, remain restrictive and are therefore often abandoned.
The CO2 laser is currently part of the therapeutic arsenal for the management of patients with GSM. This device prevents and eliminates the effects of low estrogen levels on vaginal tissue by restoring the characteristic conditions of the vaginal mucosa of a woman of childbearing age. This simple treatment, which lasts only a few minutes, is safe and painless and has no serious side effects. It restores the tone and elasticity of the tissues, with positive effects on the quality of life and the couple's relationship. The investigators wish to evaluate the possible changes of the genital sphere in a longitudinal way (before, during and after the treatment), including the induced cytohistological changes, in patients with GSM who can benefit of this therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with CO2 laser MonaLisa Touch ® sessions | Other | Device: CO2 laser MonaLisa Touch ®Women with 3 sessions of CO2 laser MonaLisa Touch ® |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women over 40 years of age
- Patients with natural menopause or menopause secondary to cancer treatment (breast, pelvis or other)
- Patients with vaginal and/or urinary, non-vulvar GSM
- Patients for whom CO2 laser therapy is proposed
Key exclusion criteria (8 listed)
- Vulvovaginal infections (vaginosis)
- Uninvestigated vaginal hemorrhage
- Herpes
- Pregnancy or breastfeeding
- Cervico-vaginal pathology (cervical and/or vaginal 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 |
|---|---|---|
| CO2 laser MonaLisa Touch ®3 sessions of SmartXide fractional CO2 laser via the MonaLisa Touch® device, spaced 4 weeks apart, will be performed. An additional comfort session will be performed at 1 year if needed. The handpiece of the MonaLisa Touch® device is applied to the vaginal walls with a 360° scan, between 800 and 1100µs, to the vaginal orifice | Device | Women with CO2 laser MonaLisa Touch ® sessions |
Primary outcome
The main objective of the study is to analyze the evolution of GSM by the use of the MonaLisa Touch ® fractionated laser.
Time frame: 3 months
The primary endpoint is the comparison of the patient's clinical score composed of a visual analogic scale measuring the intensity of symptoms related to vaginal atrophy (i.e., vaginal burning, vaginal pruritus, vaginal dryness, dyspareunia, and dysuria), before and after 3 laser sessions.
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 27 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Genitourinary Syndrome of Menopause
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Vulvar Atrophy, Vulvovaginal Signs and Symptoms
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Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
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Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment
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Genitourinary Syndrome of Menopause (GSM), Breast Cancer
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 CO2 laser MonaLisa Touch ® in people with Genitourinary Syndrome of Menopause, run by Hopital Nord Franche-Comte at 1 site in France.
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: finished, as of the sponsor's last update on 27 Dec 2024. 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 France. 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?
The main objective of the study is to analyze the evolution of GSM by the use of the MonaLisa Touch ® fractionated laser. (time frame: 3 months). 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 27 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.