跳至主要内容
临床试验/NL-OMON44049
NL-OMON44049已完成不适用

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

niversitair Medisch Centrum Groningen0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 64(—)

入选标准

  • 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

排除标准

  • 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.

研究者

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