VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-30

Study Completion Date

2026-12-31

Brief Summary

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Vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting the female adult population will be treated with a novel gel dressing to test the short- and long-term safety and efficacy of the device.

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Detailed Description

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Conditions

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Atrophic Vaginitis Vaginal Atrophy Genitourinary Syndrome of Menopause Lichen Sclerosus of Vulva Lichen Planus of Vulva Lichen Simplex of Vulva (Disorder)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Feasibility

Group Type EXPERIMENTAL

7-0940

Intervention Type DEVICE

A non-hormonal and non-steroidal gel that supports vulvovaginal mucosal conditions and speeds up recovery post vaginal rejuvenation. It is a suitable alternative to vaginally administered estrogen and topical corticosteroids, that promotes a moist healing environment leading to faster re-epithelialization. The gel relieves symptoms such as itchiness, tenderness, dryness, burning sensation, painful intercourse (dyspareunia), painful urination (dysuria), rectal and defecating pain. It improves erythema, mucosal tissue thinning, erosions, fissures, ulcerations, scarring/adhesions and swelling. It is indicated for long-term use to maintain the health of the vaginal mucosa without the side effects of vaginally administered hormonal therapy and topical corticosteroids.

Interventions

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7-0940

A non-hormonal and non-steroidal gel that supports vulvovaginal mucosal conditions and speeds up recovery post vaginal rejuvenation. It is a suitable alternative to vaginally administered estrogen and topical corticosteroids, that promotes a moist healing environment leading to faster re-epithelialization. The gel relieves symptoms such as itchiness, tenderness, dryness, burning sensation, painful intercourse (dyspareunia), painful urination (dysuria), rectal and defecating pain. It improves erythema, mucosal tissue thinning, erosions, fissures, ulcerations, scarring/adhesions and swelling. It is indicated for long-term use to maintain the health of the vaginal mucosa without the side effects of vaginally administered hormonal therapy and topical corticosteroids.

Intervention Type DEVICE

Other Intervention Names

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StrataMGT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No