Randomized, Controlled Trial With Hybrid Fractional Laser

Study Overview
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Brief Summary
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This randomized, controlled trial will evaluate hybrid fractional laser treatment for vulvovaginal atrophy in breast cancer survivors and menopausal females

Official Title
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Randomized, Controlled Trial With Hybrid Fractional Laser for Vulvovaginal Atrophy in Breast Cancer Survivors and Menopausal Females

Conditions
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Vaginal Atrophy, Sexual Dysfunction, Vaginal Dryness, Dyspareunia

Intervention / Treatment
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* Device: Hybrid Fractional Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Healthy biological female aged between 40 to 70 years 2. Is post-menopausal with a AND b OR c: No menses for at least 12 months Follicle-stimulating hormone (FSH) level over 40mlU/mL Has had a bilateral oophorectomy at least 12 months ago with no hormone replacement 3. Is experiencing at least two self-reported symptoms of GSM, such as Vaginal irritation in the absence of infection Chronic burning sensation Chronic itching in the absence of infection Recurring urinary tract infections (UTIs) Vaginal dryness during sexual activity Pain during sexual activity (dyspareunia) 4. Has been experiencing symptoms of GSM for greater than 3 months 5. Is unable due to a medical contraindication or unwilling to receive hormone-based vaginal therapy 6. Early menopause after breast cancer 7. Normal and up to date pap smear, if applicable 8. Is sexually active (i.e. intravaginal intercourse) or has the potential and desire to be sexually active if symptoms of GSM improve 9. Can read, understand and sign informed consent form 10. Has indicated willingness to participate in the study by signing an informed consent form 11. Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions Exclusion Criteria: 1. Undiagnosed abnormal genital bleeding 2. Has history of pelvic surgery or other energy-based vaginal therapy within 12 months prior to enrollment 3. Previous use of topical estrogen therapy within the last 6 months 4. Has used vaginal creams, moisturizers, lubricants or homeopathic preparations, or received anticoagulants, antiplatelet, thrombolytic, vitamin E or anti-inflammatory within 2 weeks of treatment 5. Has history of heart failure 6. Has equal to or greater than stage III prolapse, according to pelvic organ prolapse quantification system (POP-Q) 7. Has an active sexually transmitted infection (STI) 8. Has signs or symptoms of vulvitis/vaginitis 9. Has signs or symptoms of acute urinary tract infection (UTI) 10. Has participated in any clinical trial involving an investigational drug or procedure within past 30 days 11. The investigator feels that for any reason the subject is not eligible to participate in the study

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Subjects will be treated with hybrid fractional laser | Device: Hybrid Fractional Laser<br>* Hybrid Fractional Laser<br>|
| Placebo Comparator: Control Arm<br> | Device: Hybrid Fractional Laser<br>* Hybrid Fractional Laser<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Vaginal health index score (VHIS) | Scores vaginal health by scoring it from 1(none) - 5(excellent). | 6 months | 
| Change from baseline in Female sexual function index questionnaire (FSFI) | Scoring 0(minimum) - 5(maximum) | 6 months | 
| Change from baseline in day-to-day impact of vaginal aging questionnaire | Questionnaire | 6 months | 
| Change from baseline in histology | Histology | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in photography | Photography | 6 months |