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New hope for breast cancer survivors: laser and gel may ease vaginal atrophy without hormones

NCT ID NCT05585476

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 100 years

Sex

Female participants only

Healthy volunteers

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

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

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How to take part

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  1. The official record

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