RecruitingPhase 4NCT07153276

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

TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE: A PROSPECTIVE RANDOMIZED STUDY

Sponsor

University of Sao Paulo General Hospital

Enrollment

60 participants

Start Date

Feb 27, 2026

Study Type

INTERVENTIONAL

Conditions

Sjogren Syndrome Sjogren Disease Primary Sjogren Syndrome

Summary

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.

Eligibility

Sex: FEMALEMin Age: 30 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for vaginal dryness in women with Sjögren's disease — a laser-based treatment (CO2 laser) versus a topical hormone-like cream (promestriene) — to see which works better and is better tolerated. **You may be eligible if...** - You have been diagnosed with Sjögren's disease according to established criteria - Your disease is currently well controlled (low disease activity score) - You are experiencing vaginal dryness - You have agreed to participate and signed the consent form **You may NOT be eligible if...** - You have a history of breast, uterine, or ovarian cancer, blood clots, or serious heart, kidney, or liver failure - You have another autoimmune disease such as rheumatoid arthritis, lupus, or scleroderma - You have conditions that can mimic Sjögren's, such as prior head/neck radiation, HIV, hepatitis B/C, sarcoidosis, or graft-versus-host disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFractional CO2 laser (vaginal)

Vaginal fractional CO2 laser applications will be performed once a month for three consecutive months.

DRUGPromestriene Vaginal

Patients in the group treated with promestriene will apply a 10 mg vaginal capsule at night for fifteen consecutive days and, after this period, one application every three days, until completing six months of treatment.