New hope for breast cancer survivors: laser and gel may ease vaginal atrophy without hormones
NCT ID NCT05585476
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tests whether a CO2 laser combined with a regenerative gel can relieve vaginal atrophy symptoms—like dryness, pain, and itching—in 180 breast cancer survivors who cannot use hormone therapy. Participants will be randomly assigned to receive the laser plus gel, laser alone, or gel alone. The goal is to improve quality of life and reduce discomfort without hormones.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CO2 laser and regenerative topical gel
- What this could lead to
- If it works, this could offer a safe, non-hormonal option to relieve painful vaginal symptoms in breast cancer survivors.
- What could go wrong
- This is an early-stage trial with no phase assigned, so results are uncertain. The laser and gel may not provide lasting relief, and biopsies are involved.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients must meet ALL of the following criteria to be included in the study: 1. Patients over 18 years of age 2. Who have a history of breast malignancy, and are on adjuvant or neoadjuvant treatment with hormone therapy. 3. That they suffer symptoms related to vulvo-vaginal atrophy and thus become evident to the gynecological examination (Vaginal Health Index\<ó=15). 4. That this clinic significantly affects your quality of life ( score in Sexual Function-Vaginal Changes Questionnaire less than or equal to 24 points). 5. Who have not received any treatment for vulvo-vaginal atrophy in at least the previous 6 months. Purely moisturizing or emollient treatments that do not contain any regenerating substance (hyaluronic acid, gotu kola, vitamin E or rosehip oil) are not considered exclusive. 6. That they agree to participate and give their written I consent. Exclusion Criteria: Patients who present ANY of the following criteria may not be selected to participate in this study: 1. Medical or surgical history that at the discretion of the researcher does not allow participation in the study. 2. Refusal to participate in the study and to sign consent. 3. Be on chemotherapy treatment at the time of inclusion in the study. 4. Have completely completed the adjuvant hormonal treatment. 5. Have a history of vulvar, vaginal and/or cervical malignancy. 6. Have received radiation therapy to the pelvic and/or genital region. 7. Sjögren's syndrome and other pathologies that occur with mucosal involvement. 8. Present any type of disease that occurs with alteration of collagenogenesis. 9. Intake of other cytotoxic drugs that lead to mucositis and alterations of tissue regeneration in the last 6 months. 10. Have previously received laser and/or radiofrequency treatment for the treatment of genital atrophy or other pelvic floor dysfunctions. 11. Active urinary and/or genital tract infection. 12. Diagnosis of gestation at the time of recruitment. 13. History of malignant neoplasm of the urinary tract. 14. Have severe stress urinary incontinence (Sandvik test with a score equal to or greater than 8) 15. Diagnosis of pelvic organ prolapse grade III or higher according to the POP-Q classification. 16. Any other condition which, in the opinion of the investigator, means that the patient is not in a position to understand the implication of participating in the study and/or of following the established procedures.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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