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RECRUITING
NCT05379153
PHASE3

Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

Summary

This phase III trial compares the effect of vaginal fractional CO2 laser therapy to placebo for the treatment of vaginal dryness in breast cancer survivors with symptoms of genitourinary syndrome of menopause (GSM). Placebo therapy is an inactive treatment that is designed to mimic as closely as possible the active treatment being studied in a clinical trial. In this trial, patients will not be told whether they will be in the laser treatment group or the placebo group until 6-weeks after the third treatment visit (patient-blinded). At that point, patients who received placebo can elect to receive laser treatment similar to the other group. GSM is group of symptoms that affect the female genital and urinary systems and results from the lack of estrogen. Vaginal dryness can be commonly experienced with normal aging, with menopause, or come about from medications used to treat breast cancer such as chemotherapy or endocrine therapies like tamoxifen or aromatase inhibitors. Vaginal fractional CO2 laser therapy may help reduce vaginal dryness. compared to placebo.

Official title: The Revitalize Trial: Reducing Vaginal Atrophy With Fractional CO2 Laser for Breast Cancer Survivors

Key Details

Gender

FEMALE

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2026-04-21

Completion Date

2030-04-30

Last Updated

2026-10-19

Healthy Volunteers

No

Interventions

DEVICE

Laser Therapy

Undergo vaginal fractional CO2 laser therapy

DEVICE

Sham Intervention

Undergo placebo procedure

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Quality of Life Assessment

Ancillary studies

Locations (3)

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Trinity Health IHA - Obstetrics and Gynecology West Arbor

Ann Arbor, Michigan, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States