Vaginal Atrophy Patients With GSMNCT06318052
The Effect Of Fractional CO2 Laser Therapy On Cancer Survivors With Genitourinary Syndrome Of Menopause (GSM)
A study testing The FemTouch delivery system and Gynomunal gel treatment in people with Vaginal Atrophy Patients With GSM, run by Lumenis Be Ltd. at 1 site in Germany.
Trial summary
Improvement in cancer therapies has led to an increase in the number of women surviving chemotherapy (and other treatments) and overcoming cancer. This patient population presents specific clinical needs as chemotherapy (and other cancer treatments) treatment side effects can lead to early appearance of menopause… Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Vaginal Atrophy Patients With GSM
- What is being tested?
- The FemTouch delivery system and Gynomunal gel treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2019to Nov 2024
- 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 21 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who have had non-metastatic (M0, ≤Stage IIIA) cancer with any hormone receptor and her2 neu status who have completed cancer-related treatment>=6 months prior to enrollment with no evidence of metastasis or currently active disease
- Women currently on endocrine therapy, single agent Herceptin, or observation
- Patient-reported dyspareunia and/or vaginal dryness with the severity of >=4 on a scale from 0 (none) to 10 (most severe) that has been persistent for over >= 4 weeks and/or the inability to be sexually active due to pain
- Age 21 to 70 years
- Subjects seeking treatment of GSM
- Objective evidence of menopause: percentage of superficial vaginal epithelial cells of vaginal smear (MI) ≤ 5% and Vaginal fluid pH > 4.5 (for women within the first 3 years post-menopause)
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- Normal Papanicolaou (PAP) test smear last performed as a standard of care
- Negative urine analysis
- Sexually active (having sexual intercourse at least once a month) or desire to maintain sexual activity
- Informed consent process completed and subject signed a consent form.
- Able and willing to comply with the treatment/follow-up schedule and requirements
- Patient is willing to use non-hormonal contraception method during the course of the study.
Who cannot join
- Active genital infection.
- Acute or (recurring) Urinary Tract Infection (UTI) or genital infection (e.g. Herpes or candida or (condyloma ) defined as > 2 episodes in the recent year.
- Hormonal replacement therapies (local or systemic) within the last 6 weeks.
- Pelvic Organ Prolapse (POP ≥ 2) according to the pelvic organ prolapse quantification system (may be relative).
- Prior reconstructive pelvic mesh surgery.
- Previous surgery in the treated area in the last 6 months.
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- Participation in a study of another device or drug within 6 months prior to enrollment or during this study, if treatments of the vagina were involved.
- Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
- Patient is pregnant or planning to become pregnant within the next six months.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Frauenarztpraxis Heussweg
Hamburg, 20255
Matthias Theden-Scow, Dr, 4210613 ext. 040, dr.theden-schow@hamburg.de
About this study
Improvement in cancer therapies has led to an increase in the number of women surviving chemotherapy (and other treatments) and overcoming cancer. This patient population presents specific clinical needs as chemotherapy (and other cancer treatments) treatment side effects can lead to early appearance of menopause symptoms and conventional hormonal treatments are contraindicated for these patients. The use of CO2 laser treatment has been shown to provide relief of Genitourinary Syndrome Of Menopause (GSM) symptoms in women and might provide a significant improvement in the quality of life for cancer survivors. The current study is designed to demonstrate the safety and efficacy of CO2 laser for treatment of GSM symptoms in cancer survivors suffering from GSM symptoms, with limited access to hormonal treatment.
Read the detailed description
GSM-related symptoms significantly decrease the quality of life of post-menopausal women and harm the quality of life of up to seventy-five percent of breast cancer survivors who suffer from one or more GSM symptoms. Although varieties of hormonal and non-hormonal treatment options are available for post-menopausal women, the level of compliance is variable. One of the main reasons is the discomfort associated with the use of these measures, and in case of hormonal therapies certain risks and side effects. For cancer survivors, the possibility of having hormonal treatment must be considered against the possibility of increasing the risk of reoccurrence.
Therefore, women afflicted with GSM, whether it is age-related GSM or post-cancer GSM, are in need of additional therapeutic alternatives. Recently, supportive evidence is being gathered, showing that laser treatments to vaginal mucosa for GSM related symptoms are safe and effective. A prospective randomized comparative study comparing non-hormonal gel treatment to fractional CO2 vaginal laser treatment will contribute to optimizing treatment in this patient population
- Conditions
- Vaginal Atrophy Patients With GSM
- Being tested
- The FemTouch delivery system, Gynomunal gel treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The FemTouch delivery systemDevice
The FemTouch delivery system is used in conjunction with the AcuPulse CO2 laser system and the AcuScan120 microscanner to provide fractional treatments in gynecology
Gynomunal gel treatmentDrug
hormone/free, vaginal moisturizing gel for women with vaginal dryness
| Study group | Role | What they receive |
|---|---|---|
| CO2 laser treatment | Experimental | The FemTouch delivery system is used in conjunction with the AcuPulse CO2 laser system and the AcuScan120 microscanner to provide fractional treatments in gynecology. The system enables the delivery of laser energy along the vaginal walls. Through the use of the scanner, this laser energy is delivered in a fractional manner, selectively treating less than 100% of the tissue surface. This allows the tissue to heal much faster than when treating non-fractionally (100% of the surface) because much of the tissue is left unharmed, while the efficacy of the treatment remains significant. Receives: Device: The FemTouch delivery system |
| Gynomunal gel treatment | Active comparator | Gynomunal is a hormone/free, vaginal moisturizing gel for women with vaginal dryness. Gynomunal has been clinically proven in treating vaginal dryness, and its symptoms, including itching, burning, and pain (as well as discomfort during sex). Gynomunal is a liposomal formulation containing natural hop extract, Vitamin E and hyaluronic acid. Receives: Drug: Gynomunal gel treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment
Efficacy will be determined by an improvement from baseline to post-treatment in the score of the Vaginal Assessment Scale (VAS), mean of 4 items scored 0-3; 0=none 3=severe; higher score = worse condition.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment
Efficacy of fractionated CO2 laser treatments will be determined by treatment completion rates (i.e. the number of women that complete the treatment regimen out of the randomized subjects).
Measured: Through study completion, an average of 1 year
To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment.
Efficacy of fractionated CO2 laser treatments will be determined by Subject Downtime evaluation.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Nov 2019
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal Atrophy Patients With GSMStudies 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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthias Theden-Schow, Dr, Principal investigator, Central study center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318052
- Sponsor's protocol ID
- LUM-ABU-CO2-FemTouch-19-01
- Status last verified
- Feb 2024
- First submitted
- 26 Oct 2023
- Last updated
- 20 Mar 2024
- Results posted
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Fractional CO2 Laser Therapy On Cancer Survivors With Genitourinary Syndrome Of Menopause (GSM)
- ClinicalTrials.gov ID
- NCT06318052
- Acronym / sponsor ID
- LUM-ABU-CO2-FemTouch-19-01
- Conditions
- Vaginal Atrophy Patients With GSM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 19 Mar 2024 (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.
Improvement in cancer therapies has led to an increase in the number of women surviving chemotherapy (and other treatments) and overcoming cancer. This patient population presents specific clinical needs as chemotherapy (and other cancer treatments) treatment side effects can lead to early appearance of menopause symptoms and conventional hormonal treatments are contraindicated for these patients. The use of CO2 laser treatment has been shown to provide relief of Genitourinary Syndrome Of Menopause (GSM) symptoms in women and might provide a significant improvement in the quality of life for cancer survivors. The current study is designed to demonstrate the safety and efficacy of CO2 laser for treatment of GSM symptoms in cancer survivors suffering from GSM symptoms, with limited access to hormonal treatment.
Detailed description
GSM-related symptoms significantly decrease the quality of life of post-menopausal women and harm the quality of life of up to seventy-five percent of breast cancer survivors who suffer from one or more GSM symptoms. Although varieties of hormonal and non-hormonal treatment options are available for post-menopausal women, the level of compliance is variable. One of the main reasons is the discomfort associated with the use of these measures, and in case of hormonal therapies certain risks and side effects. For cancer survivors, the possibility of having hormonal treatment must be considered against the possibility of increasing the risk of reoccurrence.
Therefore, women afflicted with GSM, whether it is age-related GSM or post-cancer GSM, are in need of additional therapeutic alternatives. Recently, supportive evidence is being gathered, showing that laser treatments to vaginal mucosa for GSM related symptoms are safe and effective. A prospective randomized comparative study comparing non-hormonal gel treatment to fractional CO2 vaginal laser treatment will contribute to optimizing treatment in this patient population
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2 laser treatment | Experimental | Device: The FemTouch delivery systemThe FemTouch delivery system is used in conjunction with the AcuPulse CO2 laser system and the AcuScan120 microscanner to provide fractional treatments in gynecology. The system enables the delivery of laser energy along the vaginal walls. Through the use of the scanner, this laser energy is delivered in a fractional manner, selectively treating less than 100% of the tissue surface. This allows the tissue to heal much faster than when treating non-fractionally (100% of the surface) because much of the tissue is left unharmed, while the efficacy of the treatment remains significant. |
| Gynomunal gel treatment | Active comparator | Drug: Gynomunal gel treatmentGynomunal is a hormone/free, vaginal moisturizing gel for women with vaginal dryness. Gynomunal has been clinically proven in treating vaginal dryness, and its symptoms, including itching, burning, and pain (as well as discomfort during sex). Gynomunal is a liposomal formulation containing natural hop extract, Vitamin E and hyaluronic acid. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Women who have had non-metastatic (M0, ≤Stage IIIA) cancer with any hormone receptor and her2 neu status who have completed cancer-related treatment>=6 months prior to enrollment with no evidence of metastasis or currently active disease
- Women currently on endocrine therapy, single agent Herceptin, or observation
- Patient-reported dyspareunia and/or vaginal dryness with the severity of >=4 on a scale from 0 (none) to 10 (most severe) that has been persistent for over >= 4 weeks and/or the inability to be sexually active due to pain
- Age 21 to 70 years
- Subjects seeking treatment of GSM
Key exclusion criteria (9 listed)
- Active genital infection.
- Acute or (recurring) Urinary Tract Infection (UTI) or genital infection (e.g. Herpes or candida or (condyloma ) defined as > 2 episodes in the recent year.
- Hormonal replacement therapies (local or systemic) within the last 6 weeks.
- Pelvic Organ Prolapse (POP ≥ 2) according to the pelvic organ prolapse quantification system (may be relative).
- Prior reconstructive pelvic mesh 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 |
|---|---|---|
| The FemTouch delivery systemThe FemTouch delivery system is used in conjunction with the AcuPulse CO2 laser system and the AcuScan120 microscanner to provide fractional treatments in gynecology | Device | CO2 laser treatment |
| Gynomunal gel treatmenthormone/free, vaginal moisturizing gel for women with vaginal dryness | Drug | Gynomunal gel treatment |
Primary outcome
To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment
Time frame: Through study completion, an average of 1 year
Efficacy will be determined by an improvement from baseline to post-treatment in the score of the Vaginal Assessment Scale (VAS), mean of 4 items scored 0-3; 0=none 3=severe; higher score = worse condition.
2 secondary outcomes
To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment
Time frame: Through study completion, an average of 1 year
To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment.
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Vaginal Atrophy Patients With 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
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.
Matthias Theden-Schow, Dr principal investigator
Central study center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The FemTouch delivery system and Gynomunal gel treatment in people with Vaginal Atrophy Patients With GSM, run by Lumenis Be Ltd. at 1 site in Germany.
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 12 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 20 Mar 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 Germany. 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 Charlotte Sachs (4210613 ext. 040, csachs98@googlemail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment (time frame: Through study completion, an average of 1 year). 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 20 Mar 2024.