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

RecruitingPhase 4Ages 30 Years - 65 YearsFemaleUniversity of Sao Paulo General Hospital
NCT07153276 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 t

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of SjD according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria (2016). * Controlled systemic disease activity \[EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)\] \< 5 and without use of glucocorticoids or with a maximum dose of prednisone of 15 mg/day. * Present complaints of vaginal dryness upon study entry. * Agreeing to participate in the protocol according to the informed consent form signed before study inclusion. Exclusion Criteria: * History of breast, uterine or ovarian neoplasia, history of thromboembolic events, heart, kidney or liver failure. * Other associated autoimmune rheumatic diseases, such as spondyloarthritis, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis and mixed connective tissue disease. * Conditions that may mimic SjD, such as history of head and neck radiation therapy, acquired immunodeficiency syndrome, hepatitis B and C, sarcoidosis, IgG4-related disease, and graft-versus-host disease.
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What it tests

  • Fractional CO2 laser (vaginal)
  • Promestriene Vaginal
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Where

1 site
University of Sao Paulo General Hospital
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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