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Completed NCT05670535

Sjögren and Gynecologic Considerations

Conditions: Primary Sjögren Syndrome, Vaginitis Candida, Vaginitis, Sexual Dysfunction

Sex: Female
Ages: 20 Years – 50 Years
Enrollment: 118
Sponsor: Ankara City Hospital Bilkent

Location: Turkey

Summary

Sjögren's syndrome is an autoimmune disorder characterized by glandular and extra-glandular manifestations. It is called primary Sjögren's syndrome (pSS) in absence of another connective tissue disease. The hallmark symptoms of pSS are dry eyes and dry mouth due to the decreased lacrimal and salivary gland functions. However, other tissue and organs may also be involved which precede such as xerotrachea in upper airway, atrophic gastritis and pancreatitis in gastrointestinal tract, and dryness in vaginal mucosa.Regarding to the genital involvement in pSS, vaginal dryness and resultant vaginal discomfort, and pain are reported as the common complaints. The transudate released by vaginal mucosa is the main resource of vaginal secretions.The human microbiome was reported to have a potential impact in etiopathogenesis of certain autoimmune disorders. The previous research revealed significant alterations in the gut, eye, and oral flora of the pSS patients. The disturbed oral flora due to immunodeficiency and reduced salivary flow was also reported to make the SS patients to prone to bacterial infections and recurrent oral candidiasis. Vaginitis has been defined as a spectrum of symptoms suggesting vulvovaginal discomfort such as itching, burning, irritation, and abnormal discharge. Even the vaginitis is an evidence of disturbance in vaginal flora, previous prospective research on vaginal microbiome of pSS patients either excluded the cases with vaginitis or not mentioned from the presence of vaginitis in women with pSS. To the best of our knowledge, there has not been any study yet to define the characteristics of vaginal flora through the presence of clinical signs and symptoms in women with pSS. To gain more insight into the clinical context of the gynecologic complaints, sexual dysfunction, and presence of vaginitis in pSS, the current study aims to identify the associations between these issues and pSS related disease parameters.

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 abnormalitiesHistory 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 monthsWomen who had sexual partners with any sexual dysfunction

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05670535). StuddyBuddy aggregates publicly available trial information.