Vaginal AtrophyPhase 3NCT05379153
Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
A Phase 3 study testing Laser Therapy, Questionnaire Administration and Quality of Life Assessment in people with Vaginal Atrophy and Breast Carcinoma, run by Alliance for Clinical Trials in Oncology at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 years and older, women only
- Conditions the study is for
- Vaginal Atrophy, Breast Carcinoma
- What is being tested?
- Laser Therapy, Questionnaire Administration and Quality of Life Assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Apr 2026to 30 Apr 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with a history of breast cancer who have not had exposure to chemotherapy, targeted therapy, immunotherapy and/or radiation) within 3 months prior to registration.
- Breast cancer survivors not currently on therapy are eligible
- Patients may be receiving ongoing endocrine therapy These patients must be receiving adjuvant endocrine therapy prior to registration and intend to continue the same endocrine therapy for the 4 months while they are receiving protocol treatment, unless a clinically necessary change is indicated at the discretion of the patient's medical oncologist.
- Patients who are receiving endocrine therapy +/- monoclonal therapy like trastuzumab and pertuzumab are eligible
- Patients on targeted therapy such as CD4/6 inhibitors are not eligible. Patients receiving concurrent chemotherapy and immunotherapy are not eligible.
- Patient-reported vaginal dryness with or without dyspareunia of at least moderate severity on average, defined as >= 4 on a 0-10-point scale that has been bothersome for >= 3 months and for which the patient wants to undergo the study procedure
Show all 22Show fewer
- No prior gynecologic cancer, vaginal intra-epithelial neoplasia, pelvic radiation or pelvic reconstructive surgery utilizing mesh. Patients with cervical intraepithelial neoplasia are eligible
- No history of scleroderma, lupus, systemic sclerosis, mixed connective tissue disorder, undifferentiated connective tissue disorder or collagen vascular disease, dermatomyositis, polymyositis, lichen sclerosis or vulvar vestibulitis
- No pelvic surgery that involved a vaginal incision within 6 months of registration. Patients who received laparoscopic BSO (Bilateral salpingo-oophorectomy) are eligible
- No systemic estrogen or progesterone, vaginal estrogen, vaginal prasterone, ospemifene, and/or androgen therapy within 6 weeks prior to registration
- No other suspected contraindications for undergoing laser therapy
- No prior vaginal laser therapy at any time. Patients who would have completed any type of vaginal laser resurfacing procedure at any time prior to the start of study treatment are not eligible
- No known concurrent invasive carcinoma/malignancy. Patients with carcinoma in situ are eligible. Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible if not currently receiving treatment
- Postmenopausal based on at least one of the following criteria at the time of registration:
- Women 50 or older with no spontaneous regular menses > 12 months
- On ovarian suppression (i.e., gonadotrophin releasing hormone [GNRH] agonist/antagonist) for at least 6 months or greater, with plans to continue such treatment for at least 18 weeks
- Bilateral oophorectomy
- Women on aromatase-inhibitor (AI) therapy (i.e., clinically judged to be postmenopausal)
- In order to complete the mandatory patient-completed measures, participants must be able to speak, read and understand English or Spanish
- Age >= 22 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- No medical history of: keloid formation, genital fistula, thin recto-vaginal septum (defined as a distance of < 2 cm between the vaginal opening and the anal opening)
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 2 recruiting
- Recruiting
Trinity Health IHA - Obstetrics and Gynecology West Arbor
Ann Arbor, Michigan, 48103
Site Public Contact, MCRCwebsitecontactform@stjoeshealth.org
Gina B. Long
- Suspended
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
- Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Site Public Contact, 515-241-6727
Seema Harichand-Herdt
About this study
Official title: The Revitalize Trial: Reducing Vaginal Atrophy With Fractional CO2 Laser for Breast Cancer Survivors
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine whether vaginal fractional carbon dioxide (CO2) laser treatment is superior to vaginal placebo procedure in improving the severity of vaginal dryness, based on an 11-point (0-10) patient reported numerical analog scale.
SECONDARY OBJECTIVES:
- To determine whether vaginal fractional CO2 laser treatment is superior to vaginal placebo procedure in improving patient-reported vaginal discomfort during sexual activity, based on the vaginal discomfort domain of the Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function version (v.) 2.0 Brief Profile-Female.
II. To determine whether vaginal fractional CO2 laser therapy results in improvement in patient-reported quality of life, based on a single item 11-point numerical analog scale.
III. To evaluate potential toxicities associated with vaginal fractional CO2 laser therapy.
OUTLINE: Patients are randomized at a 2:1 ratio to Arm I and Arm II.
ARM I: Patients undergo vaginal fractional CO2 laser therapy over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo placebo procedure over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6 weeks, and 3,6, 12, 18 and 24 months after the last procedure visit.
- Conditions
- Vaginal Atrophy, Breast Carcinoma
- Being tested
- Laser Therapy, Sham Intervention, Questionnaire Administration, Quality of Life Assessment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser TherapyDevice
Undergo vaginal fractional CO2 laser therapy
Sham InterventionDevice
Undergo placebo procedure
Questionnaire AdministrationOther
Ancillary studies
Quality of Life AssessmentOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (vaginal fractional CO2 laser therapy) | Experimental | Patients undergo vaginal fractional CO2 laser therapy over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity. Receives: Device: Laser Therapy; Other: Questionnaire Administration; Other: Quality of Life Assessment |
| Arm II (placebo) | Sham comparator | Patients undergo placebo procedure over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity. Receives: Device: Sham Intervention; Other: Questionnaire Administration; Other: Quality of Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in patient reported vaginal dryness severity
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.
Measured: Up to 18 weeks
Secondary outcomes (3)
Changes in vaginal discomfort during sexual activity (for sexually active subset of study population only)
Assessed using the Vaginal discomfort domain of Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function version (V) 2.0 Brief Profile - Female (only the sexually active women will be evaluable for this, which is estimated to be approximately 50% of the population). Higher scores represent more discomfort (1: None - 5: A lot). Change in the vaginal discomfort domain of the PROMIS Sexual Function v. 2.0 Brief Profile-Female from baseline to each post-therapy-initiation time point will be summarized by treatment arm and will be compared as described for the primary endpoint.
Measured: Baseline up to 24 months after completion of treatment
Change in quality of life
Evaluated using 11-point (0-10) numerical analog scale. Higher scores represent better quality of life (0: As bad as it can be - 10: As good as it can be). Change in patient reported quality of life from baseline to each post-therapy initiation time point will be summarized and compared as described for the primary endpoint.
Measured: Baseline up to 24 months after completion of treatment
Incidence of adverse events associated with vaginal fractional CO2 laser therapy
Incidences of toxicities in the fractional CO2 laser therapy arm will be summarized by type. Common toxicities that occur in both arms will be summarized and compared between arms using the Chi-square test or Fisher's exact test, as appropriate.
Measured: Up to 24 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start21 Apr 2026
- Primary completion30 Aug 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal AtrophyStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Maryam Lustberg, MD, MPH, Study chair, Yale University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379153
- Sponsor's protocol ID
- A221801
- Other IDs
- NCI-2022-02754, UG1CA189823
- Status last verified
- Oct 2026
- First submitted
- 11 May 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Revitalize Trial: Reducing Vaginal Atrophy With Fractional CO2 Laser for Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05379153
- Acronym / sponsor ID
- A221801
- Conditions
- Vaginal Atrophy, Breast Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 30 Aug 2029 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To determine whether vaginal fractional carbon dioxide (CO2) laser treatment is superior to vaginal placebo procedure in improving the severity of vaginal dryness, based on an 11-point (0-10) patient reported numerical analog scale.
SECONDARY OBJECTIVES:
- To determine whether vaginal fractional CO2 laser treatment is superior to vaginal placebo procedure in improving patient-reported vaginal discomfort during sexual activity, based on the vaginal discomfort domain of the Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function version (v.) 2.0 Brief Profile-Female.
II. To determine whether vaginal fractional CO2 laser therapy results in improvement in patient-reported quality of life, based on a single item 11-point numerical analog scale.
III. To evaluate potential toxicities associated with vaginal fractional CO2 laser therapy.
OUTLINE: Patients are randomized at a 2:1 ratio to Arm I and Arm II.
ARM I: Patients undergo vaginal fractional CO2 laser therapy over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo placebo procedure over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6 weeks, and 3,6, 12, 18 and 24 months after the last procedure visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (vaginal fractional CO2 laser therapy) | Experimental | Device: Laser Therapy, Other: Questionnaire Administration, Other: Quality of Life AssessmentPatients undergo vaginal fractional CO2 laser therapy over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity. |
| Arm II (placebo) | Sham comparator | Device: Sham Intervention, Other: Questionnaire Administration, Other: Quality of Life AssessmentPatients undergo placebo procedure over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 22 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Women with a history of breast cancer who have not had exposure to chemotherapy, targeted therapy, immunotherapy and/or radiation) within 3 months prior to registration.
- Breast cancer survivors not currently on therapy are eligible
- Patients may be receiving ongoing endocrine therapy These patients must be receiving adjuvant endocrine therapy prior to registration and intend to continue the same endocrine therapy for the 4 months while they are receiving protocol treatment, unless a clinically necessary change is indicated at the discretion of the patient's medical oncologist.
- Patients on targeted therapy such as CD4/6 inhibitors are not eligible. Patients receiving concurrent chemotherapy and immunotherapy are not eligible.
- Patient-reported vaginal dryness with or without dyspareunia of at least moderate severity on average, defined as >= 4 on a 0-10-point scale that has been bothersome for >= 3 months and for which the patient wants to undergo the study procedure
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser TherapyUndergo vaginal fractional CO2 laser therapy | Device | Arm I (vaginal fractional CO2 laser therapy) |
| Sham InterventionUndergo placebo procedure | Device | Arm II (placebo) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (vaginal fractional CO2 laser therapy), Arm II (placebo) |
| Quality of Life AssessmentAncillary studies | Other | Arm I (vaginal fractional CO2 laser therapy), Arm II (placebo) |
Primary outcome
Changes in patient reported vaginal dryness severity
Time frame: Up to 18 weeks
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.
3 secondary outcomes
Changes in vaginal discomfort during sexual activity (for sexually active subset of study population only)
Time frame: Baseline up to 24 months after completion of treatment
Change in quality of life
Time frame: Baseline up to 24 months after completion of treatment
Incidence of adverse events associated with vaginal fractional CO2 laser therapy
Time frame: Up to 24 months after completion of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maryam Lustberg, MD, MPH study chair
Yale University Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laser Therapy, Questionnaire Administration and Quality of Life Assessment in people with Vaginal Atrophy and Breast Carcinoma, run by Alliance for Clinical Trials in Oncology at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maryam Lustberg, MD, MPH ((203) 785-4095, Maryam.lustberg@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in patient reported vaginal dryness severity (time frame: Up to 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.