Genitourinary Syndrome of MenopauseNCT06007027
Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors
A study testing SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy in people with Genitourinary Syndrome of Menopause, run by University of Aarhus at 1 site in Denmark.
Trial summary
This project will be based on three studies over a period on three years. The first study is a dose response study that includes 30 breast cancer survivors. They will receive a total of 5 laser treatments with 4-6 weeks intervals The second study is a double-blind randomized controlled trial, that includes 60 breast… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause
- What is being tested?
- SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2024to 30 Mar 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 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer survivor in endocrine therapy
- Symptomatic genitourinary symdrom of menopause with vaginal discomfort and/or dyspareunia
- Able to read and understand Danish
- Able to give written informed consent
Who cannot join
- Pelvic organ prolapse ≥ stage 2 according to the Pelvic Organ Prolapse Quantification staging system
- Use of non-hormonal/hormonal vaginal therapies (1 and 12 months prior to the baseline visit, respectively)
- Use of Chemotherapy (6 months prior to the baseline visit)
- Acute urinary tract infection or active genital infection
- History of vaginal reconstructive surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pinar Bor contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynaecology, Randers Regional Hospital
Randers, 8930
Sine Jacobsen, sinjac@rm.dk
+4578421069
About this study
Official title: Vaginal Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors - A Randomized, Blinded, Placebo-controlled Study
This project will be based on three studies over a period on three years. The first study is a dose response study that includes 30 breast cancer survivors. They will receive a total of 5 laser treatments with 4-6 weeks intervals The second study is a double-blind randomized controlled trial, that includes 60 breast cancer survivors. 30 of those will receive active intervention and 30 will receive placebo laser treatment and act as controls. Based on the results of the dose response study, a treatment consists of three to five laser treatments every 3 weeks. The third and last study is a one-year follow-up on study two. The conditions are evaluated before and after each treatment by questionnaires, vaginal fluid pH values, punch biopsies and vaginal and urine microbiome. The studies is conducted at the Department of Obstetrics and Gynaecology at Randers Regional Hospital in collaboration with Department of Obstetrics and Gynaecology and Department of Oncology at Aarhus University Hospital.
- Conditions
- Genitourinary Syndrome of Menopause
- Being tested
- SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy
- Keywords
- laser, mamma cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, ItalyDevice
The laser probe is gently inserted up to the top of the vagina, and subsequently withdrawn and rotated in order to deliver a complete treatment of the vaginal wall.
| Study group | Role | What they receive |
|---|---|---|
| Active laser group | Experimental | In the active laser group, participants are treated intravaginally with the fractional microablative CO2 laser system (SmartXIDE2V2LR, MonaLisa Touch, DEKA, Florence, Italy), using the following setting; dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μs and the smart stack parameter from 2 to 3. At the level of the vaginal introitus, the dot power decreases to 20 Watt. Receives: Device: SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy |
| Sham laser group | Sham comparator | In the sham laser group, participants are treated intravaginally with the fractional microablative CO2 laser system (SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy), using the following setting; dot power 0,5 watt, dwell time 100 μs, dot spacing 2000 μs and the smart stack parameter from 1 to 1 Receives: Device: SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal dryness
Participant are asked to complete the 10-cm visual analog scale (VAS) ranging for 0 to 10, with higher score indicating worse vaginal dryness.
Measured: Symptom data is collected at baseline visit and one month after the last treatment
Secondary outcomes (8)
Change in vaginal pain, itching and soreness
Evaluated with visual analog scale for vaginal pain, itching, soreness. 10-cm visual analog scale (VAS) ranging for 0 to 10, with higher score indicating worse symptoms.
Measured: Symptom data is collected at baseline visit and one month after the last treatment
Female Sexual Function Index
Sexual function parameters; desire, arousal, lubrication, orgasm, satisfaction and pain. Range 2-36, the threshold of 26.55 indicates sexual dysfunction
Measured: Symptom data is collected at baseline visit and one month after the last treatment
Sexual complaint screener - women
Addressing all domains of sexual dysfunction. Range 0-60, higher score indicate increased symptom severity
Measured: Symptom data is collected at baseline visit and one month after the last treatment
Urogenital Distress Inventory
For urinary symptoms; irritative symptoms, obstructive/discomfort and stress symptoms. Range 0-18, higher score indicate higher disability
Measured: Symptom data is collected at baseline visit and one month after the last treatment
International Consultation on Incontinence Questionnaire Female Urinary Tract Symptoms Sex
Evaluation of female sexual matters associated with their lower urinary tract symptoms. Range 0-14, higher values indicating increased symptom severity.
Measured: Symptom data is collected at baseline visit and one month after the last treatment
Vaginal health index
subjective scoring of moisture, fluid volume, epithelial integrity and elasticity and objective scoring of pH. Range 5-25, higher scores indicate better health
Measured: Vaginal health index is evaluated at baseline visit and one month after the last treatment
Vaginal biopsy
The biopsy of 4*4 mm is taken from the lateralt vaginal wall, 2-3 cm from inotroitus. Afterwards fixated i formalin and the processed for light microsopy by a specialized gynaecological pathologist reporting on the changes in the histology of vaginal epithel and lamina propria.
Measured: Vaginal biopsy is collected at baseline visit and one month after the last treatment
Vaginal and urinary microbiota
One polyester swap (FLOQSwab) is used to sample mid-vagina for microbial analysis and immediately been placed at - 80 °C until further processing. Urine is collected in a 50 mL collection tube using the clean catch method for women. Afterwards aliquoted into 10 mL fractions and immediately been placed at - 80 °C until further processing.
DNA is isolated from samples using standard DNA isolation kits and microbiota composition determined using 16S rRNA gene sequencing. Microbiota composition is compared between groups and over time based on alpha- and beta-diversity measures, as well as changes in relative abundances of individual bacteria.
Measured: Vaginal and urine microbiota are collected at baseline visit and one month after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Dec 2024
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Genitourinary Syndrome of MenopauseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007027
- Sponsor's protocol ID
- VagLaser
- Status last verified
- Dec 2024
- First submitted
- 1 Aug 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jacobsen S, Bennetsen MH, Nielsen PS, Glavind-Kristensen M, Jensen AB, Forman A, Waldstrom M, Bor P. Impact of fractional CO2 laser therapy on vaginal wall histology in breast cancer survivors. Lasers Med Sci. 2026 Feb 10;41(1):26. doi: 10.1007/s10103-026-04829-0.
PubMed 41665827Jacobsen S, Glavind-Kristensen M, Jensen AB, Forman A, Bor P. Vaginal CO2 laser therapy for genitourinary syndrome in breast cancer survivors-VagLaser study protocol: a randomized blinded, placebo-controlled trial. BMC Cancer. 2023 Nov 29;23(1):1164. doi: 10.1186/s12885-023-11656-x.
PubMed 38031020
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors - A Randomized, Blinded, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06007027
- Acronym / sponsor ID
- VagLaser
- Conditions
- Genitourinary Syndrome of Menopause
- Keywords
- laser, mamma cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 23 Aug 2023 (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 project will be based on three studies over a period on three years. The first study is a dose response study that includes 30 breast cancer survivors. They will receive a total of 5 laser treatments with 4-6 weeks intervals The second study is a double-blind randomized controlled trial, that includes 60 breast cancer survivors. 30 of those will receive active intervention and 30 will receive placebo laser treatment and act as controls. Based on the results of the dose response study, a treatment consists of three to five laser treatments every 3 weeks. The third and last study is a one-year follow-up on study two. The conditions are evaluated before and after each treatment by questionnaires, vaginal fluid pH values, punch biopsies and vaginal and urine microbiome. The studies is conducted at the Department of Obstetrics and Gynaecology at Randers Regional Hospital in collaboration with Department of Obstetrics and Gynaecology and Department of Oncology at Aarhus University Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active laser group | Experimental | Device: SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, ItalyIn the active laser group, participants are treated intravaginally with the fractional microablative CO2 laser system (SmartXIDE2V2LR, MonaLisa Touch, DEKA, Florence, Italy), using the following setting; dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μs and the smart stack parameter from 2 to 3. At the level of the vaginal introitus, the dot power decreases to 20 Watt. |
| Sham laser group | Sham comparator | Device: SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, ItalyIn the sham laser group, participants are treated intravaginally with the fractional microablative CO2 laser system (SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy), using the following setting; dot power 0,5 watt, dwell time 100 μs, dot spacing 2000 μs and the smart stack parameter from 1 to 1 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Breast cancer survivor in endocrine therapy
- Symptomatic genitourinary symdrom of menopause with vaginal discomfort and/or dyspareunia
- Able to read and understand Danish
- Able to give written informed consent
Key exclusion criteria (5 listed)
- Pelvic organ prolapse ≥ stage 2 according to the Pelvic Organ Prolapse Quantification staging system
- Use of non-hormonal/hormonal vaginal therapies (1 and 12 months prior to the baseline visit, respectively)
- Use of Chemotherapy (6 months prior to the baseline visit)
- Acute urinary tract infection or active genital infection
- History of vaginal reconstructive surgery
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 |
|---|---|---|
| SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, ItalyThe laser probe is gently inserted up to the top of the vagina, and subsequently withdrawn and rotated in order to deliver a complete treatment of the vaginal wall. | Device | Active laser group, Sham laser group |
Primary outcome
Vaginal dryness
Time frame: Symptom data is collected at baseline visit and one month after the last treatment
Participant are asked to complete the 10-cm visual analog scale (VAS) ranging for 0 to 10, with higher score indicating worse vaginal dryness.
8 secondary outcomes
Change in vaginal pain, itching and soreness
Time frame: Symptom data is collected at baseline visit and one month after the last treatment
Female Sexual Function Index
Time frame: Symptom data is collected at baseline visit and one month after the last treatment
Sexual complaint screener - women
Time frame: Symptom data is collected at baseline visit and one month after the last treatment
Urogenital Distress Inventory
Time frame: Symptom data is collected at baseline visit and one month after the last treatment
International Consultation on Incontinence Questionnaire Female Urinary Tract Symptoms Sex
Time frame: Symptom data is collected at baseline visit and one month after the last treatment
Vaginal health index
Time frame: Vaginal health index is evaluated at baseline visit and one month after the last treatment
Vaginal biopsy
Time frame: Vaginal biopsy is collected at baseline visit and one month after the last treatment
Vaginal and urinary microbiota
Time frame: Vaginal and urine microbiota are collected at baseline visit and one month after the last treatment
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 5 Dec 2024.
- Derived from this study: PubMed 41665827Jacobsen S, Bennetsen MH, Nielsen PS, Glavind-Kristensen M, Jensen AB, Forman A, Waldstrom M, Bor P. Impact of fractional CO2 laser therapy on vaginal wall histology in breast cancer survivors. Lasers Med Sci. 2026 Feb 10;41(1):26. doi: 10.1007/s10103-026-04829-0.
- Derived from this study: PubMed 38031020Jacobsen S, Glavind-Kristensen M, Jensen AB, Forman A, Bor P. Vaginal CO2 laser therapy for genitourinary syndrome in breast cancer survivors-VagLaser study protocol: a randomized blinded, placebo-controlled trial. BMC Cancer. 2023 Nov 29;23(1):1164. doi: 10.1186/s12885-023-11656-x.
- Individual participant dataSharing planned: Undecided
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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.
Pinar Bor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy in people with Genitourinary Syndrome of Menopause, run by University of Aarhus at 1 site in Denmark.
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 5 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 5 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 Denmark. 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 Sine Jacobsen, MD (+4578421069, sinjac@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal dryness (time frame: Symptom data is collected at baseline visit and one month after the last treatment). 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 NCT06007027, which also lists 2 linked publications.
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 5 Dec 2024.