Clinical Research Directory
Browse clinical research sites, groups, and studies.
Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
Sponsor: Alliance for Clinical Trials in Oncology
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
Conditions
Interventions
Laser Therapy
Undergo vaginal fractional CO2 laser therapy
Sham Intervention
Undergo placebo procedure
Questionnaire Administration
Ancillary studies
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