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TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE

Study acronym: VaLS
StatusRecruiting
PhasePhase 4
Started2026-02-27
View on ClinicalTrials.gov ↗

Amendment history

2026-03-02
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2029-08-20→2029-09-27
Completion date2029-12-30→2030-01-30
Start dateestimated 2026-01-19→confirmed 2026-02-27
Study sites0→1
2025-09-29
minor
Study Identification, Study Status, Conditions, Outcome Measures v1
Primary completion date2029-01-12→2029-08-20
Start date2025-11-07→2026-01-19
Secondary endpoints5 to 7 entries
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) Visual analogue scale (VAS) of vaginal dryness symptoms
Primary endpoints3 to 1 entries
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) Visual analogue scale (VAS) of vaginal dryness symptoms
Study title-8 characters
TREATMENT OF VAGINAL DRYNESS IN PRIMARY SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE
2025-08-29
minor
Original filing
Sjögren's disease (SjD) is a chronic, immune-mediated, systemic inflammatory disease characterized mainly by involvement of the salivary and lacrimal glands, causing symptoms of sicca syndrome. The disease predominantly affects women (9:1 to 20:1), with a peak incidence between 40 and 60 years of age. Symptoms of dryness include those resulting from vaginitis sicca, such as vulvovaginal irritation, dryness, pruritus, dyspareunia, polyuria, nocturia, dysuria, and urinary urgency/incontinence, which may begin before and worsen after menopause. These symptoms impact the sexual life and health-related quality of life of SjD patients. However, there are no specific recommendations for the management of vaginal dryness in this disease. Urogenital syndrome (UGS), a condition that affects women from the general population in the menopausal phase, is characterized by similar symptoms and can be treated with systemic or local hormone therapy (e.g., topical promestriene). Current data also demonstrate the efficacy and safety of vaginal fractional CO2 laser treatment for UGS. However, there are no studies on the efficacy of vaginal fractional CO2 laser and topical promestriene in the treatment of vaginal dryness in SjD.
Trial Details
NCT Number NCT07153276
Lead Sponsor University of Sao Paulo General Hospital
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions Sjogren Syndrome, Sjogren Disease, Primary Sjogren Syndrome
Enrollment 60 participants
Start Date 2026-02-27
Primary Completion 2029-09-27 (estimated)
Study Completion 2030-01-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-03