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

StatusRecruiting
PhasePhase 3
Started2026-04-21
View on ClinicalTrials.gov ↗

Amendment history

2026-09-01
minor
Study Status, Contacts/Locations v11
Study sitesdetails revised at 1 of 2 sites
2026-08-27
minor
Study Status, Study Description, Conditions, Outcome Measures, Eligibility v10
Eligibility criteria-215 characters
Inclusion Criteria: Women with a history of breast cancer treated with curative intent who have completednot primaryhad therapyexposure (consisting of surgery with or withoutto chemotherapy, targeted therapy, immunotherapy and/or radiation) >=within 123 months prior to registration. ConcurrentBreast trastuzumabcancer /pertuzumabsurvivors isnot permissiblecurrently on therapy are eligible MayPatients may be receiving ongoing adjuvant endocrine therapy (withThese anpatients AI or tamoxifen +/- ovarian function suppression). Patients are not required to receive these treatments tomust be eligible [...] [...]
2026-05-07
minor
Study Status, Contacts/Locations v9
Study sites1→2
2026-04-27
notable
Study Status, Contacts/Locations v8
Recruitment opened
Start dateestimated 2026-04→confirmed 2026-04-21
Study sitesdetails revised at 1 of 1 site
2026-04-06
minor
Study Status, Contacts/Locations v7
Study sites0→1
Show 6 earlier versions
2026-03-24
minor
Study Status v6
Start date2026-03→2026-04
2026-02-03
minor
Study Status v5
Start date2025-10→2026-03
2025-09-05
minor
Study Status v4
Primary completion date2025-09→2026-09
Start date2024-12→2025-10
2024-05-22
minor
Study Status v3
Start date2024-04→2024-12
2023-12-20
minor
Study Status v2
Start date2023-09→2024-04
2023-05-16
minor
Study Status v1
Start date2022-09→2023-09
2022-05-17
minor
Original filing
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.
Trial Details
NCT Number NCT05379153
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Vaginal Atrophy, Breast Carcinoma
Enrollment 250 participants
Start Date 2026-04-21
Primary Completion 2026-09 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-09-03