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NCT05379153 · ClinicalTrials.gov registry record · Phase 3
Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 250
- Enrollment target
NCT05379153: Recruiting Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT05379153 is a Phase 3 study that is actively recruiting participants, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 250 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05379153, a Phase 3 study, is actively recruiting participants, sponsored by Alliance for Clinical Trials in Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 250 participants
- Enrollment target
Study Summary
This phase III trial tests whether vaginal fractional CO2 laser therapy works in treating vaginal dryness in breast cancer survivors. 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.
Primary Outcome
Will use an 11-point (0-10 scale) numerical analog scale to assess patient reported severity of vaginal dryness. Higher scores represent worse symptoms (0: None - 10: Worst possible). The vaginal dryness scores at each time point will be summarized separately by treatment arm using the mean (standard deviation) and median (range). The score changes from baseline to the 18-week time point (T4) will be compared using two-sample t-test or Wilcoxon rank-sum test as appropriate.
Interventions
- OTHER Questionnaire Administration
- DEVICE Sham Intervention
- OTHER Quality of Life Assessment
- DEVICE Laser Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2026-04-21 |
| Est. Completion | 2027-05 |
| Phase | Phase 3 |
What NCT05379153 shows while recruiting
NCT05379153 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 4 interventions - of which Questionnaire Administration is the first listed.
NCT05379153 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05379153 about?
NCT05379153 is a clinical study titled "Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial". This phase III trial tests whether vaginal fractional CO2 laser therapy works in treating vaginal dryness in breast cancer survivors. 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 endo...
What is the current status of trial NCT05379153?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2026-04-21. Estimated completion is 2027-05.
What interventions are being tested in trial NCT05379153?
The interventions under investigation include: Questionnaire Administration (OTHER), Sham Intervention (DEVICE), Quality of Life Assessment (OTHER), Laser Therapy (DEVICE).
Who is sponsoring clinical trial NCT05379153?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05379153's enrollment target sits among peer trials
250 1249th of 2000 higher than 735 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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