Recruiting
Phase 3

Vaginal CO2 Laser

Sponsor:

Alliance for Clinical Trials in Oncology

Code:

NCT05379153

Conditions

Vaginal Atrophy

Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Laser Therapy

Sham Intervention

Questionnaire Administration

Quality of Life Assessment

Study Details

Brief 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.

Conditions

Vaginal Atrophy

Breast Carcinoma

Study ID

NCT05379153

Start date

Apr 21, 2026

Status verified date

Sep, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • 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)

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (vaginal fractional CO2 laser therapy)

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.

sham comparator: Arm II (placebo)

Patients undergo placebo procedure over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity.

Interventions

Laser Therapy

Undergo vaginal fractional CO2 laser therapy

Sham Intervention

Undergo placebo procedure

Questionnaire Administration

Ancillary studies

Quality of Life Assessment

Ancillary studies

Primary outcome measure

  • Changes in patient reported vaginal dryness severity [ Time Frame: Up to 18 weeks ]

Central Contacts and Locations

Central contacts

Maryam Lustberg, MD, MPH

(203) 785-4095Maryam.lustberg@yale.edu

Locations

Trinity Health IHA - Obstetrics and Gynecology West Arbor

Recruiting

Ann Arbor, Michigan, United States, 48103

Contacts

Site Public Contact

MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Gina B. Long

More Information

Sponsor

Alliance for Clinical Trials in Oncology

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology on 2026-09-03.