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This randomized, controlled trial will evaluate hybrid fractional laser treatment for vulvovaginal atrophy in breast cancer survivors and menopausal females
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Subjects will be treated with hybrid fractional laser |
|
| Control Arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid Fractional Laser | Device | Hybrid Fractional Laser |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in photography | Photography | 6 months |
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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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miamim Dermatology | Miami | Florida | 33173 | United States |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| D004414 | Dyspareunia |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |