EligibleTrials

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

Recruiting · NCT05379153 · Interventional (participants receive a specific treatment)

View the official record on ClinicalTrials.gov →
Breast cancer

Interventions studied

Laser TherapyQuality of Life AssessmentQuestionnaire AdministrationSham Intervention

What this trial is about

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.

Who can take part

Age range
22 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)

Inclusion criteria

Where it is running

2 locations listed across 2 US states.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →

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