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Can a gel ease menopause symptoms that disrupt daily life?

NCT ID NCT07737782

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study examines the most common symptoms of genitourinary syndrome of menopause (GSM) in postmenopausal women and how these symptoms impact quality of life. Researchers will also look at whether using a non-hormonal topical gel called XCM INTIM for at least 8 weeks is linked to changes in symptom severity and quality-of-life measures. The study uses medical records and patient questionnaires to gather data.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a non-hormonal topical vulvovaginal gel called XCM INTIM
What this could lead to
If the data suggest improvement, it could support the use of this gel for easing GSM symptoms and improving quality of life.
What could go wrong
This is a small, retrospective study that looks back at existing records, so it cannot prove cause and effect. Results may not apply to all women.

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.

Participants

About 100 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Postmenopausal women attended at the Department of Obstetrics and Gynecology of Hospital Universitario La Luz between January 2022 and April 2026, with at least one symptom of GSM documented in their medical records.

Ages

40 to 75 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 included in this retrospective data evaluation must have met all of the following criteria: * Postmenopausal women (defined as at least 12 consecutive months of amenorrhea) * Present at least one symptom of GSM documented in the medical record * Evidence in the medical record that the patient had perceived the GSM symptom(s) as having an impact on her quality of life. * Documentation in the medical record that the patient had initiated treatment with XCM INTIM, together with follow-up clinical data including an assessment performed at least 8 weeks after treatment initiation. * Patients that had attended at the Department of Obstetrics and Gynecology of Hospital Universitario La Luz between January 2022 and April 2026, regardless of whether they had participated in another study during this period. Exclusion Criteria: Patients will be excluded from the study if any of the following conditions were present: * Use of topical vulvovaginal hormonal products within 4 weeks prior to initiation of XCM INTIM treatment. * Use of systemic estrogen therapy within 8 weeks prior to initiation of XCM INTIM treatment. * Presence of relevant gynecological and/or urinary conditions that could have interfered with the assessment of symptoms attributed to GSM, including but not limited to active vulvovaginal and/or urinary tract infections, significant vulvar lesions, active gynecological malignancies, severe stress urinary incontinence (Sandvik score ≥ 8), pelvic organ prolapse stage III or higher (POP-Q), or any other condition considered by the investigator to be a significant confounding factor. * Previous radiotherapy involving the pelvic and/or genital region. * Previous laser and/or radiofrequency treatment in the pelvic region. * Medical records containing insufficient information for analysis of the primary study variables.

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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.

  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

  • Hospital Universitario La Luz Quirónsalud

    Madrid, Madrid, 28003, Spain

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