The pathogenesis of vaginal dryness in women with primary Sjögren*s syndrome: a pilot study

Completed

• Conditions: Sjögren's syndrome; 10003816

• Registration Number: NL-OMON44049
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-09-25
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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

• 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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Immunohistochemistry of vaginal and endocervical mucosa </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Immunological parameters in the vagina, e.g. the local expression of<br /><br>chemokines and cytokines in the vaginal and cervical tissue and secretions.<br /><br>- Gynaecological parameters, e.g. the vaginal health index (VHI)<br /><br>- Clinical disease parameters, e.g. disease activity<br /><br>- patient reported parameters, e.g. sexual function, vaginal complaints,<br /><br>patient reported symptoms of pSS</p><br>