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Trial Title:
The Effect Of Fractional CO2 Laser Therapy On Cancer Survivors With Genitourinary Syndrome Of Menopause (GSM)
NCT ID:
NCT06318052
Condition:
Vaginal Atrophy Patients With GSM
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
The FemTouch delivery system
Description:
The FemTouch delivery system is used in conjunction with the AcuPulse CO2 laser system
and the AcuScan120 microscanner to provide fractional treatments in gynecology
Arm group label:
CO2 laser treatment
Intervention type:
Drug
Intervention name:
Gynomunal gel treatment
Description:
hormone/free, vaginal moisturizing gel for women with vaginal dryness
Arm group label:
Gynomunal gel treatment
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 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
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
21 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Frauenarztpraxis Heussweg
Address:
City:
Hamburg
Zip:
20255
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Matthias Theden-Scow, Dr
Phone:
4210613
Phone ext:
040
Email:
dr.theden-schow@hamburg.de
Start date:
November 1, 2019
Completion date:
November 2024
Lead sponsor:
Agency:
Lumenis Be Ltd.
Agency class:
Industry
Source:
Lumenis Be Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06318052