- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06318052
The Effect Of Fractional CO2 Laser Therapy On Cancer Survivors With Genitourinary Syndrome Of Menopause (GSM)
Study Overview
Status
Conditions
Intervention / 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Charlotte Sachs
- Phone Number: 040 4210613
- Email: csachs98@googlemail.com
Study Locations
-
-
-
Hamburg, Germany, 20255
- Recruiting
- Frauenarztpraxis Heussweg
-
Contact:
- Matthias Theden-Scow, Dr
- Phone Number: 040 4210613
- Email: dr.theden-schow@hamburg.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CO2 laser treatment
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.
|
The FemTouch delivery system is used in conjunction with the AcuPulse CO2 laser system and the AcuScan120 microscanner to provide fractional treatments in gynecology
|
Active Comparator: Gynomunal gel treatment
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.
|
hormone/free, vaginal moisturizing gel for women with vaginal dryness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 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).
|
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
|
Efficacy of fractionated CO2 laser treatments will be determined by Subject Downtime evaluation.
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthias Theden-Schow, Dr, Central study center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LUM-ABU-CO2-FemTouch-19-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vaginal Atrophy Patients With GSM
-
Petra LarmoTurun Gynekologikeskus Oy; Tekes - The Finnish Funding Agency for Technology...CompletedVaginal Atrophy | Vaginal Dryness | Vulvar Atrophy | Vulvar DrynessFinland
-
Istanbul University - Cerrahpasa (IUC)RecruitingVaginal Atrophy | Dyspareunia | Laser | Genitourinary Syndrome of Menopause (GSM)Turkey
-
Rajavithi HospitalTerminatedVaginal Atrophy | Oxytocin Gel | Postmenopausal Women | Vaginal Maturation IndexThailand
-
BionovoUnknownVaginal Atrophy | Vulvar AtrophyUnited States
-
Sun Pharmaceutical Industries LimitedTerminated
-
Bitop AGCompleted
-
University of Texas Southwestern Medical CenterAmerican Society for Aesthetic Plastic SurgeryCompleted
-
Dr. August Wolff GmbH & Co. KG ArzneimittelproDERM GmbHCompleted
-
National and Kapodistrian University of AthensIRCCS San RaffaeleUnknown
-
Syneron MedicalUnknownVaginal AtrophyUnited States
Clinical Trials on The FemTouch delivery system
-
Boston Scientific CorporationActive, not recruitingNon-valvular Atrial FibrillationChina
-
Stealth BioTherapeutics Inc.CompletedAge-related Macular DegenerationUnited States
-
Edwards LifesciencesActive, not recruitingAortic Stenosis | Aortic Regurgitation | Symptomatic Aortic StenosisChina
-
Edwards LifesciencesCompletedAortic Stenosis | Aortic Regurgitation | Symptomatic Aortic StenosisChina
-
U.S. Army Medical Research and Development CommandActive, not recruiting
-
Medtronic CardiovascularMedtronicCompletedBlunt Thoracic Aortic InjuryUnited States, Canada
-
Medtronic CardiovascularMedtronicCompleted
-
Center for Research on Reproductive Health of CampinasFundação de Amparo à Pesquisa do Estado de São PauloUnknownAnxiety | LumbagoBrazil
-
University Hospital, GhentRecruitingHypoglycemia | Gastric Outlet Obstruction | Steatohepatitis | Gastric Bypass | Parenteral SupportBelgium
-
Tulane UniversityUniversity of Pennsylvania; National Heart, Lung, and Blood Institute (NHLBI); Pennington Biomedical Research CenterRecruitingHyperglycemia | Obesity | PreDiabetes | Gestational Diabetes | Glucose Intolerance During Pregnancy | Lifestyle, HealthyUnited States