Primary Sjögren SyndromeNCT05670535
Sjögren and Gynecologic Considerations
An observational study of Primary Sjögren Syndrome and Vaginitis Candida, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Primary Sjögren Syndrome, Vaginitis Candida, Vaginitis
- What is being tested?
- Visual analogue scale (VAS) for dyspareunia, Visual analogue scale (VAS) for vaginal dryness and The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 10 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Adult
Study population: This study is designed as a prospective cohort study, to include sexually active 118 women at reproductive age who had the symptoms of itching, burning, irritation, and abnormal discharge. Women with pSS (study group, n=49) will be compared with women who had not any other disease or complaint rather than vaginal discharge (control group, n=69). All the participants will be recruited from sexually active women with single sexual partner.
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Infections and Sexual Dysfunction in Women With Primary Sjögren's Syndrome
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.
Read the detailed description
Sjögren's syndrome is an autoimmune disorder characterized by glandular and extra-glandular manifestations. In the absence of another connective tissue disease, it is called primary Sjögren's syndrome (pSS). 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 affected including the 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. In this prospective cohort study, we planned to include sexually active 118 women at reproductive age who had the symptoms of itching, burning, irritation, and abnormal discharge. Women with pSS (study group, n=49) will be compared with women who had not any other disease or complaint rather than vaginal discharge (control group, n=69). Besides the physical examination and gynecological evaluation including sterile speculum examination enabling swab sampling for vaginal discharge and PAP smear; the Visual analogue scales (VAS) for dyspareunia, and vaginal dryness and The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI), and Sjögren's Syndrome Patient Reported Index (ESSPRI) Sjögren's syndrome disease activity will be also performed. Correlation and regression analyses will be also performed for pSS related parameters.
- Being tested
- Visual analogue scale (VAS) for dyspareunia, Visual analogue scale (VAS) for vaginal dryness, The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI), The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)
- Keywords
- Acute vaginitis, Dyspareunia, Gynecological complaints, Sexual dysfunction, Sjögren's Syndrome, Vaginal candidiasis
- Medical subject headings
- Candidiasis, Vulvovaginal, Vaginitis, Sexual Dysfunction, Physiological, Dyspareunia, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual analogue scale (VAS) for dyspareuniaOther
Dyspareunia scores between 0 to 10 points
Visual analogue scale (VAS) for vaginal drynessOther
Vaginal dryness scores between 0 to 10 points
The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)Other
Sjögren's Syndrome Disease Activity Index scores between 0 to 3 points
The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)Other
Sjögren's Syndrome Patient Reported Index scores between 0 to 10 points
| Study group | Role | What they receive |
|---|---|---|
| pSS group (Study group) | * Women with the diagnosis of pSS for at least 3 years.
* At reproductive age (without menopause).
* Receiving only hydroxychloroquine sulfate treatment.
* Presence of the symptoms of vaginitis. Receives: Other: Visual analogue scale (VAS) for dyspareunia; Other: Visual analogue scale (VAS) for vaginal dryness; Other: The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI); Other: The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) | |
| Women without pSS (Control group) | * Women without any known disease.
* At reproductive age (without menopause).
* Presence of the symptoms of vaginitis. Receives: Other: Visual analogue scale (VAS) for dyspareunia; Other: Visual analogue scale (VAS) for vaginal dryness; Other: The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI); Other: The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal candidiasis
Culture of swab sampling from vaginal fluid at Sabouraud dextrose agar plates incubated in CO2 for evaluation of candida
Measured: 20 minutes
Acute vaginitis
Laboratory assessment of vaginal swab sampling from vaginal fluid for bacterial vaginosis
Measured: 10 minutes
Visual analogue scale for dyspareunia
The severity of symptoms scored between 0 (no symptoms) to 10 (worst symptoms) points.
Measured: 20 minutes
Visual analogue scale for vaginal dryness
The severity of symptoms scored between 0 (no symptoms) to 10 (worst symptoms) points.
Measured: 20 minutes
The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)
The severity of clinical signs regarding Sjögren's Syndrome disease activity, scored between 0 (no symptoms) to 3 (worst symptoms) points.
Measured: 20 minutes
The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)
he severity of patient reported symptoms regarding Sjögren's Syndrome, scored between 0 (no symptoms) to 10 (worst symptoms) points.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Mar 2021
- Primary completion15 Oct 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Primary Sjögren SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esin Merve Erol Koç, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670535
- Sponsor's protocol ID
- E1-20-1290
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research data is not shared unless it is needed.
Publications
Mariette X, Criswell LA. Primary Sjogren's Syndrome. N Engl J Med. 2018 Mar 8;378(10):931-939. doi: 10.1056/NEJMcp1702514. No abstract available.
PubMed 29514034Priori R, Minniti A, Derme M, Antonazzo B, Brancatisano F, Ghirini S, Valesini G, Framarino-dei-Malatesta M. Quality of Sexual Life in Women with Primary Sjogren Syndrome. J Rheumatol. 2015 Aug;42(8):1427-31. doi: 10.3899/jrheum.141475. Epub 2015 Jul 1.
PubMed 26136488Mulherin DM, Sheeran TP, Kumararatne DS, Speculand B, Luesley D, Situnayake RD. Sjogren's syndrome in women presenting with chronic dyspareunia. Br J Obstet Gynaecol. 1997 Sep;104(9):1019-23. doi: 10.1111/j.1471-0528.1997.tb12060.x.
PubMed 9307528Brito-Zeron P, Baldini C, Bootsma H, Bowman SJ, Jonsson R, Mariette X, Sivils K, Theander E, Tzioufas A, Ramos-Casals M. Sjogren syndrome. Nat Rev Dis Primers. 2016 Jul 7;2:16047. doi: 10.1038/nrdp.2016.47.
PubMed 27383445ACOG Committee on Practice Bulletins--Gynecology. ACOG Practice Bulletin. Clinical management guidelines for obstetrician-gynecologists, Number 72, May 2006: Vaginitis. Obstet Gynecol. 2006 May;107(5):1195-1206. doi: 10.1097/00006250-200605000-00049.
PubMed 16648432
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Infections and Sexual Dysfunction in Women With Primary Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT05670535
- Acronym / sponsor ID
- E1-20-1290
- Keywords
- Acute vaginitis, Dyspareunia, Gynecological complaints, Sexual dysfunction, Sjögren's Syndrome, Vaginal candidiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sjögren's syndrome is an autoimmune disorder characterized by glandular and extra-glandular manifestations. In the absence of another connective tissue disease, it is called primary Sjögren's syndrome (pSS). 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 affected including the 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. In this prospective cohort study, we planned to include sexually active 118 women at reproductive age who had the symptoms of itching, burning, irritation, and abnormal discharge. Women with pSS (study group, n=49) will be compared with women who had not any other disease or complaint rather than vaginal discharge (control group, n=69). Besides the physical examination and gynecological evaluation including sterile speculum examination enabling swab sampling for vaginal discharge and PAP smear; the Visual analogue scales (VAS) for dyspareunia, and vaginal dryness and The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI), and Sjögren's Syndrome Patient Reported Index (ESSPRI) Sjögren's syndrome disease activity will be also performed. Correlation and regression analyses will be also performed for pSS related parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pSS group (Study group) | – | Other: Visual analogue scale (VAS) for dyspareunia, Other: Visual analogue scale (VAS) for vaginal dryness, Other: The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI), Other: The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)* Women with the diagnosis of pSS for at least 3 years. * At reproductive age (without menopause). * Receiving only hydroxychloroquine sulfate treatment. * Presence of the symptoms of vaginitis. |
| Women without pSS (Control group) | – | Other: Visual analogue scale (VAS) for dyspareunia, Other: Visual analogue scale (VAS) for vaginal dryness, Other: The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI), Other: The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)* Women without any known disease. * At reproductive age (without menopause). * Presence of the symptoms of vaginitis. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- This study is designed as a prospective cohort study, to include sexually active 118 women at reproductive age who had the symptoms of itching, burning, irritation, and abnormal discharge. Women with pSS (study group, n=49) will be compared with women who had not any other disease or complaint rather than vaginal discharge (control group, n=69). All the participants will be recruited from sexually active women with single sexual partner.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual analogue scale (VAS) for dyspareuniaDyspareunia scores between 0 to 10 points | Other | Women without pSS (Control group), pSS group (Study group) |
| Visual analogue scale (VAS) for vaginal drynessVaginal dryness scores between 0 to 10 points | Other | Women without pSS (Control group), pSS group (Study group) |
| The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)Sjögren's Syndrome Disease Activity Index scores between 0 to 3 points | Other | Women without pSS (Control group), pSS group (Study group) |
| The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)Sjögren's Syndrome Patient Reported Index scores between 0 to 10 points | Other | Women without pSS (Control group), pSS group (Study group) |
Primary outcome
Vaginal candidiasis
Time frame: 20 minutes
Culture of swab sampling from vaginal fluid at Sabouraud dextrose agar plates incubated in CO2 for evaluation of candida
Acute vaginitis
Time frame: 10 minutes
Laboratory assessment of vaginal swab sampling from vaginal fluid for bacterial vaginosis
Visual analogue scale for dyspareunia
Time frame: 20 minutes
The severity of symptoms scored between 0 (no symptoms) to 10 (worst symptoms) points.
Visual analogue scale for vaginal dryness
Time frame: 20 minutes
The severity of symptoms scored between 0 (no symptoms) to 10 (worst symptoms) points.
The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)
Time frame: 20 minutes
The severity of clinical signs regarding Sjögren's Syndrome disease activity, scored between 0 (no symptoms) to 3 (worst symptoms) points.
The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)
Time frame: 20 minutes
he severity of patient reported symptoms regarding Sjögren's Syndrome, scored between 0 (no symptoms) to 10 (worst symptoms) points.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Results publication: PubMed 29514034Mariette X, Criswell LA. Primary Sjogren's Syndrome. N Engl J Med. 2018 Mar 8;378(10):931-939. doi: 10.1056/NEJMcp1702514. No abstract available.
- Results publication: PubMed 26136488Priori R, Minniti A, Derme M, Antonazzo B, Brancatisano F, Ghirini S, Valesini G, Framarino-dei-Malatesta M. Quality of Sexual Life in Women with Primary Sjogren Syndrome. J Rheumatol. 2015 Aug;42(8):1427-31. doi: 10.3899/jrheum.141475. Epub 2015 Jul 1.
- Results publication: PubMed 9307528Mulherin DM, Sheeran TP, Kumararatne DS, Speculand B, Luesley D, Situnayake RD. Sjogren's syndrome in women presenting with chronic dyspareunia. Br J Obstet Gynaecol. 1997 Sep;104(9):1019-23. doi: 10.1111/j.1471-0528.1997.tb12060.x.
- Results publication: PubMed 27383445Brito-Zeron P, Baldini C, Bootsma H, Bowman SJ, Jonsson R, Mariette X, Sivils K, Theander E, Tzioufas A, Ramos-Casals M. Sjogren syndrome. Nat Rev Dis Primers. 2016 Jul 7;2:16047. doi: 10.1038/nrdp.2016.47.
- Results publication: PubMed 16648432ACOG Committee on Practice Bulletins--Gynecology. ACOG Practice Bulletin. Clinical management guidelines for obstetrician-gynecologists, Number 72, May 2006: Vaginitis. Obstet Gynecol. 2006 May;107(5):1195-1206. doi: 10.1097/00006250-200605000-00049.
- Individual participant dataSharing planned: No. The research data is not shared unless it is needed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Sjögren Syndrome and Vaginitis Candida, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal candidiasis (time frame: 20 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05670535, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.