A Phase 4 interventional study of 7-940 in Vaginal Atrophy, Atrophic Vaginitis and Genitourinary Syndrome of Menopause (GSM), sponsored by Stratpharma AG. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Stratpharma AG · Phase 4, Interventional, and Supportive care
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.
45 studies on the registry are indexed under Atrophic Vaginitis; 7 are open to participants now.
This study's enrollment of 11 is below the median of 69 across 40 interventional studies indexed under Atrophic Vaginitis.
Browse Atrophic Vaginitis studies →Stratpharma AG is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: 7-940
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.
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
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
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
Recovery Improvement Question
Descriptive patient-related questions, assessing the improvement post-laser therapy.
Time frame: 30-45 days
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
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Stratpharma AG