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

Sponsor
University of Sao Paulo General Hospital
Study ID
NCT07153276
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
30 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Fractional CO2 laser (vaginal) — DEVICE
    Vaginal fractional CO2 laser applications will be performed once a month for three consecutive months.
  • Promestriene Vaginal — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 27, 2026
Status verified
Mar 2026
Primary completion
Sep 27, 2029
Completion
Jan 30, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SjD with sicca vagintis complaints treated with vaginal fractional CO2 laser
    Thirty SjD patients with vaginitis sicca symptoms allocated to the intervention group (vaginal fractional CO2 laser)
  • Active Comparator: SjD with sicca vagintis complaints treated with topical promestriene
    Thirty SjD patients with vaginitis sicca symptoms allocated to the comparator group (topical promestriene)

Primary Outcome Measure

Vaginal Health Index (VHI) [ Time Frame: Four and six months ]

Central Contacts

Related Studies