Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-24 @ 10:16 PM
NCT ID:
NCT05670535
Eligibility Criteria:
Inclusion Criteria:
* All participants are recruited from women who consecutively applied to outpatient clinic.
* Normally menstruating women at reproductive age (without menopause) for all participants.
* Regular sexual activity with single sexual partner for all participants.
* Receiving only hydroxychloroquine sulfate treatment for women with pSS.
* Presence of the symptoms of vaginitis for all participants.
* Without any known disease including autoimmune disorders for women in control group.
Exclusion Criteria:
* Women with the pelvic anatomical structural abnormalities
* History of any type of cancer including gynecological cancers, chemotherapy, and/or radiotherapy,
* Endometriosis, chronic cervicitis, menopause, pregnancy, lactation, use of hormonal contraceptive medication, use of vaginal estrogen, pre-malign or malign cytology at Papanicolaou (PAP) smear, having intrauterine device,
* Smoking,
* Chronic diseases (diabetes mellitus, psychiatric disorders,
* Multiple sexual partners, sexually transmitted infections including gonorrhea, chlamydia, genital herpes, and/or mycoplasma, mixed vaginal infections,
* Urinary tract infection in last three months,
* Antibiotic medication at last one month,
* Administration of drugs which may lead vaginal dryness including antihistaminics, antidepressants, and anti-hypertensives,
* Treatment with glucocorticoids, biologic disease modifying anti-rheumatic drugs, or immune-suppressive agents at last three months
* Women who had sexual partners with any sexual dysfunction
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT05670535
Study Brief:
Protocol Section:
NCT05670535