Actively Recruiting
Phase 4
Age: 30Years - 65Years
FEMALE
ID07153276
Treatment of Vaginal Dryness in Sj f6gren's Disease With CO2-Laser Versus Topical Promestriene A Prospective Randomized Study
Led by University of Sao Paulo General Hospital · Updated on 2026-03-03
60
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
U
University of Sao Paulo General Hospital
Lead Sponsor
F
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Sj f6gren's disease (SjD) is a chronic inflammatory condition mainly affecting the salivary and lacrimal glands, leading to dryness symptoms. It mostly affects women between 40 and 60 years old and causes vaginal dryness symptoms that impact quality of life. There are currently no specific treatments for vaginal dryness in SjD, though similar symptoms in menopausal women can be treated with hormone therapy or vaginal fractional CO2 laser, which has shown safety and effectiveness in other conditions. This study is a 6-month randomized clinical trial comparing two treatments for vaginal dryness in SjD patients: vaginal fractional CO2 laser therapy and topical promestriene. Sixty women with SjD and vaginal dryness will be split evenly into two groups. The laser group will receive monthly laser treatments for three months, while the promestriene group will apply vaginal capsules nightly for 15 days, then every three days until six months of treatment is completed. Participants will be monitored over the study period with evaluations at four and six months after starting treatment. Assessments include vaginal health, sexual function, quality of life, urinary symptoms, and vaginal dryness severity. Safety will be checked monthly during treatment and at follow-up visits. The study aims to measure improvements in vaginal health and symptom relief while tracking any side effects, with total participation lasting six months.
CONDITIONS
Brief Title
TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE
Who Can Participate
Age: 30Years - 65Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Diagnosis of Sj�f6gren's disease according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2016 criteria
- Controlled systemic disease activity with ESSDAI score less than 5
- Use of no glucocorticoids or prednisone dose up to 15 mg/day
- Complaints of vaginal dryness at study entry
- Signed informed consent agreeing to participate in the study
You will not qualify if you...
- History of breast, uterine, or ovarian cancer
- History of thromboembolic events
- Heart, kidney, or liver failure
- Presence of other autoimmune rheumatic diseases such as spondyloarthritis, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, or mixed connective tissue disease
- Conditions mimicking Sj�f6gren's disease like history of head and neck radiation, AIDS, hepatitis B or C, sarcoidosis, IgG4-related disease, or graft-versus-host disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants are treated with either vaginal fractional CO2 laser or topical promestriene to address vaginal dryness in Sjögren's disease.
3 monthly visits for laser applications or ongoing use of promestriene capsules over 6 months with periodic assessments
Follow-up
Duration - Up to 6 months from treatment start
Participants are monitored for treatment effects and safety after treatment completion.
Monthly visits for safety assessments up to 6 months
Trial Site Locations
Total: 1 location
1
University of Sao Paulo General Hospital
São Paulo, São Paulo, Brazil
Actively Recruiting
Loading map...
Research Team
E
Eloisa Bonfa, Full prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
[Validation of the "International Consultation on Incontinence Questionnaire -- Short Form" (ICIQ-SF) for Portuguese].
José Tadeu Nunes Tamanini, Miriam Dambros, Carlos Arturo Levi D'Ancona...
https://pubmed.ncbi.nlm.nih.gov/15243675Validation of the Six-item Female Sexual Function Index in Middle-Aged Brazilian Women.
Mona Lúcia Dall'Agno, Charles Francisco Ferreira, Fernanda Vargas Ferreira...
https://pubmed.ncbi.nlm.nih.gov/31344717Development and validation of a 6-item version of the female sexual function index (FSFI) as a diagnostic tool for female sexual dysfunction.
Andrea M Isidori, Carlotta Pozza, Katherine Esposito...
https://pubmed.ncbi.nlm.nih.gov/19968774Vaginal dryness in primary Sjögren's syndrome: a histopathological case-control study.
Jolien F van Nimwegen, Karin van der Tuuk, Silvia C Liefers...
https://pubmed.ncbi.nlm.nih.gov/32044981The impact of primary Sjögren's syndrome on female sexual function.
Jolien F van Nimwegen, Suzanne Arends, Greetje S van Zuiden...
https://pubmed.ncbi.nlm.nih.gov/256520722016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjögren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts.
Caroline H Shiboski, Stephen C Shiboski, Raphaèle Seror...
https://pubmed.ncbi.nlm.nih.gov/27785888Transcultural adaptation of the "EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)" into Brazilian Portuguese.
Erica Vieira Serrano, Valéria Valim, Samira Tatiyama Miyamoto...
https://pubmed.ncbi.nlm.nih.gov/24477727EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI): development of a consensus patient index for primary Sjogren's syndrome.
Raphaèle Seror, Philippe Ravaud, Xavier Mariette...
https://pubmed.ncbi.nlm.nih.gov/21345815EULAR Sjogren's syndrome disease activity index: development of a consensus systemic disease activity index for primary Sjogren's syndrome.
Raphaèle Seror, Philippe Ravaud, Simon J Bowman...
https://pubmed.ncbi.nlm.nih.gov/19561361