Sjögren's syndrome
Conditions
Interventions
Autoimmune
Pathogenesis
Sjögren's syndrome
Vaginal dryness
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients: • Diagnosis of pSS according to the American European Consensus Group (AECG) classification criteria. • Presence of vaginal sicca symptoms ;All participants: • Female gender • Age >=18 • Premenopausal status according to the World Health Organisation definition. • Written informed consent
Exclusion criteria
Exclusion criteria: • Presence of other systemic autoimmune disease • Use of systemische corticosteroids within 1 month before inclusion. • Use of disease modifying anti-rheumatic drugs (DMARDs), except hydroxychloroquine, within 1 month before inclusion. • Use of biological DMARDs within 6 months before inclusion. • Use of hormone replacement therapy or use of vaginal oestrogen supplementation • Use of a intrauterine contraceptive device • Pregnancy • Presence of a known infectious or non-infectious inflammatory disorder of the vagina or cervix (e.g. lichen sclerosis or lichen planus of the vagina, sexually transmitted infections) • Other gynaecological or non-gynaecological comorbidity which is expected to influence the vaginal or cervical health and/or gynaecological immune markers according to the investigators, including previous chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunohistochemistry of vaginal and endocervical mucosa | — |
Secondary
| Measure | Time frame |
|---|---|
| - Immunological parameters in the vagina, e.g. the local expression of chemokines and cytokines in the vaginal and cervical tissue and secretions. - Gynaecological parameters, e.g. the vaginal health index (VHI) - Clinical disease parameters, e.g. disease activity - patient reported parameters, e.g. sexual function, vaginal complaints, patient reported symptoms of pSS | — |
Countries
The Netherlands
Outcome results
None listed