Genitourinary Syndrome of Menopause (GSM)NCT05156502
To Assess Signs and Symptoms in Women Affected by GSM After One Cycle of Pixel CO2-Alma Fractionated Laser
A study testing Fractionated Laser (Pixel CO2-Alma) and Fractionated Laser (Pixel CO.2-Alma) in people with Genitourinary Syndrome of Menopause (GSM) and Vaginal Dryness, run by Dr. Filippo Murina at 1 site in Italy.
Trial summary
Genitourinary syndrome of menopause (GSM) occurs in approximately 50% of menopausal women but is both underrecognized and undertreated despite numerous treatment options. Vaginal dryness, irritation, dyspareunia, urinary frequency, and urinary urgency are some of the more common symptoms that can have a negative… Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genitourinary Syndrome of Menopause (GSM), Vaginal Dryness, Burning
- What is being tested?
- Fractionated Laser (Pixel CO2-Alma) and Fractionated Laser (Pixel CO.2-Alma)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jan 2022to Aug 2022
- 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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- menopausal women aged between 40 and 70 years old (defined as Absence of menstruation for 12 consecutive months).
- women affected by Genitourinary syndrome of menopause (GSM) with Vaginal dryness, burning/pain, dyspareunia, dysuria.
- women not treated with Replacement therapy with estrogen and progestogen (HT) or estrogen alone (ET) or selective estrogen receptor modulators (SERMS) in the last 3 months
Who cannot join
- hypersensitivity to laser
- clinically significant findings on physical examination
- any chronic medical condition or psychologic disorder that per opinion of the Principal Investigator would make the patient ineligible for the study
- vulvo-vestibular lesion not related with GSM
- active vaginal or vulvar infections (e.g., herpes, candida, STIs)
- prolapse beyond the hymen
Show all 9Show fewer
- subject has a history of scarring alteration (ie, keloid formation)
- unknown past or active history of vaginal bleeding disorders
- any condition or behavior indicating to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ospedale dei Bambini V Buzzi
Milan, 20154
Filippo Buzzi", MD, +390263635420, filippo.murina@asst-fbf-sacco.it
About this study
Official title: An Open-Label, Interventional, Controlled Study To Assess The Performance And Tolerance Of Pixel CO2-Alma Fractionated Laser in Women Affected by GenitoUrinary Syndrome of Menopause (GSM)
Genitourinary syndrome of menopause (GSM) occurs in approximately 50% of menopausal women but is both underrecognized and undertreated despite numerous treatment options. Vaginal dryness, irritation, dyspareunia, urinary frequency, and urinary urgency are some of the more common symptoms that can have a negative effect on women's lives and relationships. In particular, dyspareunia is localized in the vestibule with specific trophic changes more evident than those localized in vagina. The CO2 fractionated laser, has also been found to be useful in several studies for the treatment of vaginal atrophy.
In this open comparative study, 70 female menopausal subjects aged between 40 and 70 years old at inclusion, having symptoms of GSM (Vaginal dryness, burning/pain, dyspareunia,dysuria), have given her informed consent and meet all the eligibility criteria, will be enrolled. The two groups of comparison will be 35 subjects treated into vagina and vestibule, versus 35 subjects treated into vagina, only. Subjects will come to a total of 6 visits over a period of 3 months.
The primary objective of the study is to evaluate the performance and safety of Pixel CO2-Alma Fractionated Laser comparing its administration into vagina and vestibule versus into vagina, only. The evaluated outcomes are vaginal dryness, burning/pain, dyspareunia, sensitivity to touch at Swab test, Female Sexual Function Index (FSFI) and Vulval Pain Functional Questionnaire (VQ) at day 84 and 120 and the safety during all the study. The secondary objectives are the evaluation of vaginal and vestibular trophism, measured by Vaginal Health Index (VHI) and Vestibular Health Score (VHS) at the FU visits.
- Conditions
- Genitourinary Syndrome of Menopause (GSM), Vaginal Dryness, Burning, Pain, Dyspareunia, Dysuria
- Being tested
- Fractionated Laser (Pixel CO2-Alma), Fractionated Laser (Pixel CO.2-Alma)
- Keywords
- Genitourinary syndrome of menopause (GSM), Fractionated Laser, Vaginal dryness., dyspareunia
- Medical subject headings
- Paresthesia, Pain, Dyspareunia, Dysuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractionated Laser (Pixel CO2-Alma)Device
The Laser will be administered at baseline (visit 2, day 0), at visit 3 (day 28) and at visit 4 (day 56) into vagina and vestibule, following the IFU of the device.
Fractionated Laser (Pixel CO.2-Alma)Device
Device: Fractionated Laser (Pixel CO2-Alma) The Laser will be administered at baseline (visit 2, day 0), at visit 3 (day 28) and at visit 4 (day 56) into vagina only, following the IFU of the device.
| Study group | Role | What they receive |
|---|---|---|
| Fractionated Laser | Experimental | Not described Receives: Device: Fractionated Laser (Pixel CO2-Alma) |
| Fractionated.Laser | Active comparator | Not described Receives: Device: Fractionated Laser (Pixel CO.2-Alma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal dryness by Visual Analogue Scale
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Measured: 120 days
Burning/pain by Visual Analogue Scale
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Measured: 120 days
Dyspareunia by Visual Analogue Scale
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Measured: 120 days
Pain/sensitivity to touch at Swab test by Visual Analogue Scale.
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Measured: 120 days
Sexual Function by Female Sexual Function Index
Sexual function will be evaluated at baseline and after 84 and 120 days by the Italian validated translation of the Female Sexual Function Index (FSFI), a self-report instrument consisting of 19 items that assess sexual function over the past 4 weeks in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. Mean value in each group separately and in the two groups in comparison will be analyzed.
Measured: 120 days
Vulval Pain by Vulval Pain Functional Questionnaire
The Vulval Pain Functional Questionnaire (VQ) will be used to quantify the extent that pelvic pain is affecting the patients. A numerical value is assigned to each response. The higher the score the greater the functional limitation. A diminishing score represents improvement.
Measured: 120 days
Incidence of Treatment-Emergent Adverse Events/ Adverse Device Events/ Serious Adverse Events/ Serious Adverse Device Events [Safety and Tolerability]
The incidence will be calculated by searching for Adverse Event (AE), Adverse Device Event ADE, Serious Adverse Event (SAE), Serious Adverse Device Event (SADE) at each visit
Measured: up to 120 days
Secondary outcomes (2)
Vestibular Trophism by Vaginal Health Index
The changing from baseline to day 84 (visit 5) and 120 (final visit) for Vaginal Health Index (VHI) mean value in each group separately and the changing in Arm A in comparison with that occurred in Arm B. The VHI score evaluates 5 parameters (vaginal elasticity, vaginal secretions, vaginal pH, epithelial mucous membrane, vaginal hydration) and to obtain a final score defining the degree of atrophy in the genitourinary tract by assigning a single score to each parameter. The minim score is 5 and the maxim is 25.
Measured: 120 days
Vestibular Trophism by Vestibular Health Score
Vestibular Health Score (VHS) will be used by the Investigator evaluating 5 parameters (Petechiae, Pallor, Fragility, dryness, Erythema) and to obtain a final score defining the degree of atrophy. Each item is scored on a Likert scale between 0 =absent and 3 =severe. Total scores range from 0 to 15.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start30 Jan 2022 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionAug 2022 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Filippo Murina
- Sponsor type
- University, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor-investigator, Dr. Filippo Murina, ASST Fatebenefratelli Sacco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156502
- Sponsor's protocol ID
- SSSM-2020-03.1
- Status last verified
- Dec 2021
- First submitted
- 27 Oct 2021
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Interventional, Controlled Study To Assess The Performance And Tolerance Of Pixel CO2-Alma Fractionated Laser in Women Affected by GenitoUrinary Syndrome of Menopause (GSM)
- ClinicalTrials.gov ID
- NCT05156502
- Acronym / sponsor ID
- SSSM-2020-03.1
- Conditions
- Genitourinary Syndrome of Menopause (GSM), Vaginal Dryness, Burning, Pain, Dyspareunia, Dysuria
- Keywords
- Genitourinary syndrome of menopause (GSM), Fractionated Laser, Vaginal dryness., dyspareunia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dr. Filippo MurinaUniversity, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- 30 Jan 2022 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 14 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.
Genitourinary syndrome of menopause (GSM) occurs in approximately 50% of menopausal women but is both underrecognized and undertreated despite numerous treatment options. Vaginal dryness, irritation, dyspareunia, urinary frequency, and urinary urgency are some of the more common symptoms that can have a negative effect on women's lives and relationships. In particular, dyspareunia is localized in the vestibule with specific trophic changes more evident than those localized in vagina. The CO2 fractionated laser, has also been found to be useful in several studies for the treatment of vaginal atrophy.
In this open comparative study, 70 female menopausal subjects aged between 40 and 70 years old at inclusion, having symptoms of GSM (Vaginal dryness, burning/pain, dyspareunia,dysuria), have given her informed consent and meet all the eligibility criteria, will be enrolled. The two groups of comparison will be 35 subjects treated into vagina and vestibule, versus 35 subjects treated into vagina, only. Subjects will come to a total of 6 visits over a period of 3 months.
The primary objective of the study is to evaluate the performance and safety of Pixel CO2-Alma Fractionated Laser comparing its administration into vagina and vestibule versus into vagina, only. The evaluated outcomes are vaginal dryness, burning/pain, dyspareunia, sensitivity to touch at Swab test, Female Sexual Function Index (FSFI) and Vulval Pain Functional Questionnaire (VQ) at day 84 and 120 and the safety during all the study. The secondary objectives are the evaluation of vaginal and vestibular trophism, measured by Vaginal Health Index (VHI) and Vestibular Health Score (VHS) at the FU visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractionated Laser | Experimental | Device: Fractionated Laser (Pixel CO2-Alma) |
| Fractionated.Laser | Active comparator | Device: Fractionated Laser (Pixel CO.2-Alma) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- menopausal women aged between 40 and 70 years old (defined as Absence of menstruation for 12 consecutive months).
- women affected by Genitourinary syndrome of menopause (GSM) with Vaginal dryness, burning/pain, dyspareunia, dysuria.
- women not treated with Replacement therapy with estrogen and progestogen (HT) or estrogen alone (ET) or selective estrogen receptor modulators (SERMS) in the last 3 months
Key exclusion criteria (9 listed)
- hypersensitivity to laser
- clinically significant findings on physical examination
- any chronic medical condition or psychologic disorder that per opinion of the Principal Investigator would make the patient ineligible for the study
- vulvo-vestibular lesion not related with GSM
- active vaginal or vulvar infections (e.g., herpes, candida, STIs)
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 |
|---|---|---|
| Fractionated Laser (Pixel CO2-Alma)The Laser will be administered at baseline (visit 2, day 0), at visit 3 (day 28) and at visit 4 (day 56) into vagina and vestibule, following the IFU of the device. | Device | Fractionated Laser |
| Fractionated Laser (Pixel CO.2-Alma)Device: Fractionated Laser (Pixel CO2-Alma) The Laser will be administered at baseline (visit 2, day 0), at visit 3 (day 28) and at visit 4 (day 56) into vagina only, following the IFU of the device. | Device | Fractionated.Laser |
Primary outcome
Vaginal dryness by Visual Analogue Scale
Time frame: 120 days
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Burning/pain by Visual Analogue Scale
Time frame: 120 days
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Dyspareunia by Visual Analogue Scale
Time frame: 120 days
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Pain/sensitivity to touch at Swab test by Visual Analogue Scale.
Time frame: 120 days
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Sexual Function by Female Sexual Function Index
Time frame: 120 days
Sexual function will be evaluated at baseline and after 84 and 120 days by the Italian validated translation of the Female Sexual Function Index (FSFI), a self-report instrument consisting of 19 items that assess sexual function over the past 4 weeks in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. Mean value in each group separately and in the two groups in comparison will be analyzed.
Vulval Pain by Vulval Pain Functional Questionnaire
Time frame: 120 days
The Vulval Pain Functional Questionnaire (VQ) will be used to quantify the extent that pelvic pain is affecting the patients. A numerical value is assigned to each response. The higher the score the greater the functional limitation. A diminishing score represents improvement.
Incidence of Treatment-Emergent Adverse Events/ Adverse Device Events/ Serious Adverse Events/ Serious Adverse Device Events [Safety and Tolerability]
Time frame: up to 120 days
The incidence will be calculated by searching for Adverse Event (AE), Adverse Device Event ADE, Serious Adverse Event (SAE), Serious Adverse Device Event (SADE) at each visit
2 secondary outcomes
Vestibular Trophism by Vaginal Health Index
Time frame: 120 days
Vestibular Trophism by Vestibular Health Score
Time frame: 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
Related trials for Genitourinary Syndrome of Menopause (GSM)
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
Not yet recruitingPhase 4
Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
Menopausal Complaints, Vaginal Atrophy
Not yet recruiting
Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment
Genitourinary Syndrome of Menopause (GSM), Bacterial Vaginosis
RecruitingObservational study
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
Genitourinary Syndrome of Menopause (GSM), Breast Cancer
Recruiting
Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractionated Laser (Pixel CO2-Alma) and Fractionated Laser (Pixel CO.2-Alma) in people with Genitourinary Syndrome of Menopause (GSM) and Vaginal Dryness, run by Dr. Filippo Murina at 1 site in Italy.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Dec 2021. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Filippo Murina, MD (+39 0263635420, filippo.murina@asst-fbf-sacco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal dryness by Visual Analogue Scale (time frame: 120 days). The study lists 7 primary outcomes in all. 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 14 Dec 2021.