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New gel dressing aims to ease vaginal discomfort for thousands of women

NCT ID NCT05953090

Symptom relief Sponsor: Stratpharma AG 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing a new gel dressing for women with vaginal atrophy, lichen sclerosus, or similar vulvar skin conditions. About 2000 adult women will use the gel and report their symptoms and quality of life over 12 months. The goal is to see if the gel safely reduces discomfort and improves daily life.

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 2,000 people

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

Started

Oct 2023

Expected to finish

Dec 2028

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.

Ages

18 years and older

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: * Diagnosed atrophic vaginitis, lichen sclerosus, lichen simplex chronicus or lichen planus * Continuous vulvovaginal symptoms * Access to smartphone and tablet, laptop or computer * Access to a valid email address Exclusion Criteria: * Unable to provide informed consent * Patient unable to apply topical device * Allergy or intolerance to ingredients or excipients of the formulation of studied products * Systemic hormonal therapy started less than 30 days before baseline * Systemic corticosteroids ongoing treatment or used within the last 30 days before baseline * Ongoing topical HRT or corticosteroid treatment for the indication under investigation * Topical HRT or corticosteroid treatment used for the indication under investigation within the last 30 days before baseline

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Conditions

The condition(s) this trial relates to.

lichen planus lichen sclerosus et atrophicus neurodermatitis postmenopausal atrophic vaginitis vulvar lichen sclerosus

As listed by the trial registrant

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

Atrophic vaginitis Genitourinary syndrome of menopause Lichen planus of vulva Lichen sclerosus of vulva Lichen simplex of vulva (disorder) Vaginal atrophy

How to take part

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

  1. The places running it

    13 sites. 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

  • Cahaba Dermatology & Skin Health Center

    RECRUITING

    Birmingham, Alabama, 35244, United States

  • Orange Coast Women's Medical Group

    ACTIVE_NOT_RECRUITING

    Laguna Hills, California, 92653, United States

  • Southern Urogynecology

    RECRUITING

    West Columbia, South Carolina, 29169, United States

  • Velvet Clinical Research

    RECRUITING

    Burbank, California, 91506, United States

  • WR-Carolina Institute for Clinical Research

    RECRUITING

    Fayetteville, North Carolina, 28303, United States

  • WR-Charleston Clinical Trials, LLC

    NOT_YET_RECRUITING

    Charleston, South Carolina, 29414, United States

  • WR-Clinical Research Center of Nevada, LLC

    NOT_YET_RECRUITING

    Las Vegas, Nevada, 89106, United States

  • WR-Global Medical Research, LLC

    RECRUITING

    Dallas, Texas, 75224, United States

  • WR-Medical Research Center of Memphis, LLC

    NOT_YET_RECRUITING

    Memphis, Tennessee, 38210, United States

  • WR-Mount Vernon Clinical Research, LLC

    NOT_YET_RECRUITING

    Sandy Springs, Georgia, 30328, United States

  • WR-Multi-Specialty Research Associates

    NOT_YET_RECRUITING

    Lake City, Florida, 32055, United States

  • WR-PRI, LLC (Los Alamitos)

    NOT_YET_RECRUITING

    Los Alamitos, California, 90720, United States

  • WR-PRI, LLC (Newport Beach)

    RECRUITING

    Newport Beach, California, 92660, United States

  • WR-Women's Health Care Research, LLC

    NOT_YET_RECRUITING

    San Diego, California, 92111, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.