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New combo therapy aims to soothe menopause symptoms without long-term drugs

NCT ID NCT06873971

Symptom relief Sponsor: University of Nove de Julho Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding a special laser treatment to a standard estrogen cream works better than the cream alone for postmenopausal women with vaginal dryness, burning, or pain during sex. Sixty women aged 45–70 will be randomly assigned to receive either a real or sham laser along with the cream. Researchers will measure vaginal health, symptoms, and quality of life over several months.

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 60 people

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

Started

Dec 2025

Expected to finish

Dec 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

45 to 70 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 * Postmenopausal women (45-70 years of age). * At least one of moderate symptom of GSM (vaginal dryness, burning sensation, dyspareunia, and persistent leukorrhea), defined by ≥ 4 on Visual Analog Scale (VAS) ranging from 0 to 10. * Vaginal pH ≥5.0 at baseline assessment. * Not having undergone hormone replacement therapy (vaginal or systemic) in the previous six months. * No use of vaginal moisturizers in the previous 30 days. * Demonstrated capacity and willingness to provide written informed consent and adhere to study protocols. Exclusion criteria * Vaginal or vulvar energy-based interventions (e.g., laser, radiofrequency) in the previous six months. * Abnormal cervical cytology, specifically ASCUS, LSIL, or HSIL, documented in the previous six months. * Systemic corticosteroid therapy administered in the previous 90 days. * Body mass index (BMI) ≥35 kg/m². * Presence of abnormal uterine bleeding in the previous 30 days. * History of vaginal surgery in the previous 180 days or grade II or higher uterine prolapse (POP-q). * History of malignant neoplasms or exposure to vaginal radiotherapy. * Diagnosis of severe liver or kidney disease, autoimmune disease, or severe psychiatric disorder.

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Conditions

The condition(s) this trial relates to.

postmenopausal atrophic vaginitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Genitourinary syndrome of menopause

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Universidade Nove de Julho

    RECRUITING

    São Paulo, São Paulo, 01525-000, Brazil

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