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ASSIST-VLA: Assessment of Symptom-Specific Improvement in Diagnosed Vaginal Atrophy Following Laser Therapy

ConditionsVaginal AtrophyAtrophic VaginitisGenitourinary Syndrome of Menopause (GSM)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorStratpharma AG

About this trial

Vaginal atrophy patients receiving vaginal laser therapy will be treated with daily 7-0940® following a laser session to evaluate the safety and efficacy of the product as an adjunct treatment. Clinical outcomes will be assessed using validated investigator- and patient-reported measures, with safety and symptom progression monitored throughout the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed vaginal atrophy

Access to smartphone and tablet, laptop or computer

Access to a valid email address

Previously completed laser therapy session schedule

Disqualifiers

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 or steroidal therapy started less than 30 days before baseline ( = not yet on a stable regimen)

Trial design

Design model

Single group

Treatments tested in this trial

  • 7-940

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: SafetyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Vaginal Health Index Score (VHIS)

Objective clinical assessment for assessment of the device safety as adjunctive treatment after laser therapy forr women with vaginal atrophy. The objective validation of clinical signs (elasticity, fluid volume, pH, epithelial integrity, moisture) using a commonly used scale.

Time frame
30 - 45 days
2

Vulvar Disease Quality of Life Index questionnaire

The patient-rated quality of life will be assessed at baseline and during each monthly follow-up using the validated patient-rated Vulvar Disease Quality of Life Index (VQLI). \[min:0; max:45\]. A higher score thereby correlates to a worse outcome. The secondary endpoint is the change from baseline VQLI score at 30 - 45 days.

Time frame
30 - 45 days
3

Investigator-reported improvement in vaginal atrophy signs

Signs (dryness, tissue thinning, erosion, fissures, erythema, scarring, contact bleeding, labial fusion, labia reabsorption and contracture of posterior introitus) are rated by the investigator during a physical assessment at baseline and after 30 - 45 days, using a 10-point Likert scale ranging from 0=normal to 10=worst possible.

Time frame
30-45 days
4

Recovery Improvement Question

Descriptive patient-related questions, assessing the improvement post-laser therapy.

Time frame
30-45 days

Secondary outcomes

1

Change in complication rate

Any adverse reactions or complications, are rated by the investigator during each assessment baseline and after 30 - 45 days.

Time frame
30 - 45 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stratpharma AG

Lead sponsor

Source ClinicalTrials.gov
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