Sjogren SyndromePhase 4VaLSNCT07153276

TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE

A Phase 4 study testing Fractional CO2 laser (vaginal) and Promestriene Vaginal in people with Sjogren Syndrome and Sjogren Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 30 to 65 years, women only
Conditions the study is for: Sjogren Syndrome, Sjogren Disease, Primary Sjogren Syndrome
What is being tested?: Fractional CO2 laser (vaginal) and Promestriene Vaginal
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteBrazil
Study dates: 27 Feb 2026to 30 Jan 2030
Phase: Phase 4
Are there results?: Not yet: the study is under way

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 30 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of SjD according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria (2016).
Controlled systemic disease activity [EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)] < 5 and without use of glucocorticoids or with a maximum dose of prednisone of 15 mg/day.
Present complaints of vaginal dryness upon study entry.
Agreeing to participate in the protocol according to the informed consent form signed before study inclusion.

Who cannot join

History of breast, uterine or ovarian neoplasia, history of thromboembolic events, heart, kidney or liver failure.
Other associated autoimmune rheumatic diseases, such as spondyloarthritis, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis and mixed connective tissue disease.
Conditions that may mimic SjD, such as history of head and neck radiation therapy, acquired immunodeficiency syndrome, hepatitis B and C, sarcoidosis, IgG4-related disease, and graft-versus-host disease.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eloisa Bonfa, Full prof. contact

+55 11 30617492

eloisa.bonfa@hc.fm.usp.br

Brazil1 site, 1 recruiting

University of Sao Paulo General Hospital
São Paulo, São Paulo
Eloisa Bonfa, Full professor, +55 11 30617492, eloisa.bonfa@hc.fm.usp.br
Recruiting

Other trials in Brazil

About this study

Official title: TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE: A PROSPECTIVE RANDOMIZED STUDY

Sjögren's disease (SjD) is a chronic, immune-mediated, systemic inflammatory disease characterized mainly by involvement of the salivary and lacrimal glands, causing symptoms of sicca syndrome. The disease predominantly affects women (9:1 to 20:1), with a peak incidence between 40 and 60 years of age. Symptoms of dryness include those resulting from vaginitis sicca, such as vulvovaginal irritation, dryness, pruritus, dyspareunia, polyuria, nocturia, dysuria, and urinary urgency/incontinence, which may begin before and worsen after menopause. These symptoms impact the sexual life and health-related quality of life of SjD patients. However, there are no specific recommendations for the management of vaginal dryness in this disease. Urogenital syndrome (UGS), a condition that affects women from the general population in the menopausal phase, is characterized by similar symptoms and can be treated with systemic or local hormone therapy (e.g., topical promestriene). Current data also demonstrate the efficacy and safety of vaginal fractional CO2 laser treatment for UGS. However, there are no studies on the efficacy of vaginal fractional CO2 laser and topical promestriene in the treatment of vaginal dryness in SjD.

Read the detailed description

This is a prospective randomized study lasting 6 months. Sixty SjD patients (pre- or post-menopausal) and with complaints of vaginal dryness will be included and randomized into two groups: 30 patients for the intervention group - vaginal fractional CO2 laser - and 30 patients for the comparator group - topical promestriene. Vaginal fractional CO2 laser applications will be performed once a month for three consecutive months. Patients in the group treated with promestriene will apply a 10 mg vaginal capsule at night for fifteen consecutive days and, after this period, one application every three days, until completing six months of treatment.

Conditions: Sjogren Syndrome, Sjogren Disease, Primary Sjogren Syndrome
Being tested: Fractional CO2 laser (vaginal), Promestriene Vaginal
Keywords: Sjogren syndrome, vaginal dryness, vaginitis sicca, vaginal fractional CO2 laser, promestriene
Medical subject headings: Sjogren's Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fractional CO2 laser (vaginal)Device
Vaginal fractional CO2 laser applications will be performed once a month for three consecutive months.
Promestriene VaginalDrug
Patients in the group treated with promestriene will apply a 10 mg vaginal capsule at night for fifteen consecutive days and, after this period, one application every three days, until completing six months of treatment.

Study groups in NCT07153276
Study group	Role	What they receive
SjD with sicca vagintis complaints treated with vaginal fractional CO2 laser	Experimental	Thirty SjD patients with vaginitis sicca symptoms allocated to the intervention group (vaginal fractional CO2 laser) Receives: Device: Fractional CO2 laser (vaginal)
SjD with sicca vagintis complaints treated with topical promestriene	Active comparator	Thirty SjD patients with vaginitis sicca symptoms allocated to the comparator group (topical promestriene) Receives: Drug: Promestriene Vaginal

What is being measured

The primary outcome is the main question the study is designed to answer.

Vaginal Health Index (VHI)
To assess the improvement in the Vaginal Health Index (VHI) after treatment compared to the patient's baseline status in both arms. This score ranges from 5 (minimum) to 25 (maximum) and higher values indicate better outcomes.
Measured: Four and six months

Secondary outcomes (7)

6-Item version of the Female Sexual Function Index (FSFI)
To assess the improvement in the 6-item version of the Female Sexual Function Index (FSFI) after treatment compared to the patient's baseline status in both arms. This score ranges from 0 (minimum) to 30 (maximum) and higher values indicate better outcomes.
Measured: Four and six months
Primary Sjögren's Syndrome Quality of Life questionnaire (PSSQoL)
To assess the improvement in the Primary Sjögren's Syndrome Quality of Life questionnaire (PSSQoL) after treatment compared to the patient's baseline status in both arms. This score ranges from 0 (minimum) to 96 (maximum) and higher values indicate worse outcomes.
Measured: Four and six months
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
To assess the improvement in the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) after treatment compared to the patient's baseline status in both arms. This score ranges from 0 (minimum) to 21 (maximum) and higher values indicate worse outcomes.
Measured: Four and six months
Visual analogue scale (VAS) of vaginal dryness symptoms
To assess the improvement in the visual analogue scale (VAS) of vaginal dryness symptoms after treatment compared to the patient's baseline status in both arms. This scale ranges from 0 (minimum) to 10 (maximum) and higher values indicate worse outcomes.
Measured: Four and six months
Persistence of the beneficial effects of laser therapy - visual analogue scale (VAS) of vaginal dryness symptoms
To assess the possible persistence of the beneficial effects of laser therapy after the end of applications (in the medium term). This assessment will be performed by observing improvements on the visual analogue scale (VAS) of vaginal dryness symptoms after treatment compared to the patient's baseline status in both arms. This scale ranges from 0 (minimum) to 10 (maximum) and higher values indicate worse outcomes.
Measured: Six months
Incidence of treatment-emergent adverse events (safety and tolerability)
To assess the incidence of treatment-emergent adverse events (as a percentage) in the two arms of the study.
Measured: One month, two months, three months, four months, five months, six months
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) (safety and tolerability)
To assess the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) after treatment compared to the patient's baseline status in both study arms. This score ranges from 0 (minimum) to 123 (maximum) and higher values indicate worse outcomes.
Measured: Four and six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Feb 202630 Jan 2030

First posted3 Sep 2025
Study start27 Feb 2026
Primary completion27 Sep 2029 (estimated)
Study completion30 Jan 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Sjogren SyndromeStudies of the same condition, open and under way.
More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07153276
Sponsor's protocol ID: 67377523.3.0000.0068
Acronym: VaLS
Status last verified: Mar 2026
First submitted: 20 Aug 2025
Last updated: 3 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Abstracts of the International Continence Society 31st annual meeting. Seoul, Korea, 18-21 September 2001. Neurourol Urodyn. 2001;20(4):371-576. No abstract available.
PubMed 11522151
Tamanini JT, Dambros M, D'Ancona CA, Palma PC, Rodrigues Netto N Jr. [Validation of the "International Consultation on Incontinence Questionnaire -- Short Form" (ICIQ-SF) for Portuguese]. Rev Saude Publica. 2004 Jun;38(3):438-44. doi: 10.1590/s0034-89102004000300015. Epub 2004 Jul 8. Portuguese.
PubMed 15243675
Dall'Agno ML, Ferreira CF, Ferreira FV, Perez-Lopez FR, Wender MCO. Validation of the Six-item Female Sexual Function Index in Middle-Aged Brazilian Women. Rev Bras Ginecol Obstet. 2019 Jul;41(7):432-439. doi: 10.1055/s-0039-1692694. Epub 2019 Jul 25.
PubMed 31344717
Isidori AM, Pozza C, Esposito K, Giugliano D, Morano S, Vignozzi L, Corona G, Lenzi A, Jannini EA. Development and validation of a 6-item version of the female sexual function index (FSFI) as a diagnostic tool for female sexual dysfunction. J Sex Med. 2010 Mar;7(3):1139-46. doi: 10.1111/j.1743-6109.2009.01635.x. Epub 2009 Dec 1.
PubMed 19968774
van Nimwegen JF, van der Tuuk K, Liefers SC, Verstappen GM, Visser A, Wijnsma RF, Vissink A, Hollema H, Mourits MJE, Bootsma H, Kroese FGM. Vaginal dryness in primary Sjogren's syndrome: a histopathological case-control study. Rheumatology (Oxford). 2020 Oct 1;59(10):2806-2815. doi: 10.1093/rheumatology/keaa017.
PubMed 32044981
van Nimwegen JF, Arends S, van Zuiden GS, Vissink A, Kroese FG, Bootsma H. The impact of primary Sjogren's syndrome on female sexual function. Rheumatology (Oxford). 2015 Jul;54(7):1286-93. doi: 10.1093/rheumatology/keu522. Epub 2015 Feb 4.
PubMed 25652072
Shiboski CH, Shiboski SC, Seror R, Criswell LA, Labetoulle M, Lietman TM, Rasmussen A, Scofield H, Vitali C, Bowman SJ, Mariette X; International Sjogren's Syndrome Criteria Working Group. 2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts. Arthritis Rheumatol. 2017 Jan;69(1):35-45. doi: 10.1002/art.39859. Epub 2016 Oct 26.
PubMed 27785888
Serrano EV, Valim V, Miyamoto ST, Giovelli RA, Paganotti MA, Cade NV. Transcultural adaptation of the "EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)" into Brazilian Portuguese. Rev Bras Reumatol. 2013 Nov-Dec;53(6):483-93. doi: 10.1016/j.rbr.2013.04.003. English, Portuguese.
PubMed 24477727
Seror R, Ravaud P, Mariette X, Bootsma H, Theander E, Hansen A, Ramos-Casals M, Dorner T, Bombardieri S, Hachulla E, Brun JG, Kruize AA, Praprotnik S, Tomsic M, Gottenberg JE, Devauchelle V, Devita S, Vollenweider C, Mandl T, Tzioufas A, Carsons S, Saraux A, Sutcliffe N, Vitali C, Bowman SJ; EULAR Sjogren's Task Force. EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI): development of a consensus patient index for primary Sjogren's syndrome. Ann Rheum Dis. 2011 Jun;70(6):968-72. doi: 10.1136/ard.2010.143743. Epub 2011 Feb 22.
PubMed 21345815
Seror R, Ravaud P, Bowman SJ, Baron G, Tzioufas A, Theander E, Gottenberg JE, Bootsma H, Mariette X, Vitali C; EULAR Sjogren's Task Force. EULAR Sjogren's syndrome disease activity index: development of a consensus systemic disease activity index for primary Sjogren's syndrome. Ann Rheum Dis. 2010 Jun;69(6):1103-9. doi: 10.1136/ard.2009.110619. Epub 2009 Jun 28.
PubMed 19561361
Seganfredo IB, Bianchi C, Tacla M, Chedraui P, Haddad JM, Simoes R, Baracat EC, Soares JM Jr. Comparison of promestriene with vaginal fractional CO2 laser and radiofrequency treatments of genitourinary syndrome of menopause. Maturitas. 2024 Aug;186:108008. doi: 10.1016/j.maturitas.2024.108008. Epub 2024 Apr 24.
PubMed 38714422
Samuels JB, Garcia MA. Treatment to External Labia and Vaginal Canal With CO2 Laser for Symptoms of Vulvovaginal Atrophy in Postmenopausal Women. Aesthet Surg J. 2019 Jan 1;39(1):83-93. doi: 10.1093/asj/sjy087.
PubMed 29726916
Salvatore S, Ruffolo AF, Phillips C, Athanasiou S, Cardozo L, Serati M; EUGA Working Group. Vaginal laser therapy for GSM/VVA: where we stand now - a review by the EUGA Working Group on Laser. Climacteric. 2023 Aug;26(4):336-352. doi: 10.1080/13697137.2023.2225766. Epub 2023 Jul 3.
PubMed 37395104
Priori 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 26136488
Politano CA, Costa-Paiva L, Aguiar LB, Machado HC, Baccaro LF. Fractional CO2 laser versus promestriene and lubricant in genitourinary syndrome of menopause: a randomized clinical trial. Menopause. 2019 Aug;26(8):833-840. doi: 10.1097/GME.0000000000001333.
PubMed 31246661

Interested in taking part?

Eloisa Bonfa, Full prof.

+55 11 30617492

eloisa.bonfa@hc.fm.usp.br

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Sjogren Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE: A PROSPECTIVE RANDOMIZED STUDY
ClinicalTrials.gov ID: NCT07153276
Acronym / sponsor ID: VaLS / 67377523.3.0000.0068
Conditions: Sjogren Syndrome, Sjogren Disease, Primary Sjogren Syndrome
Keywords: Sjogren syndrome, vaginal dryness, vaginitis sicca, vaginal fractional CO2 laser, promestriene
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: University of Sao Paulo General HospitalUniversity, hospital or other
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
Study start: 27 Feb 2026 (actual)
Primary completion: 27 Sep 2029 (estimated)
Study completion: 30 Jan 2030 (estimated)
First posted: 3 Sep 2025 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SjD with sicca vagintis complaints treated with vaginal fractional CO2 laser	Experimental	Device: Fractional CO2 laser (vaginal)Thirty SjD patients with vaginitis sicca symptoms allocated to the intervention group (vaginal fractional CO2 laser)
SjD with sicca vagintis complaints treated with topical promestriene	Active comparator	Drug: Promestriene VaginalThirty SjD patients with vaginitis sicca symptoms allocated to the comparator group (topical promestriene)

Who may qualify

Ages: 30 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosis of SjD according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria (2016).
Controlled systemic disease activity [EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)] < 5 and without use of glucocorticoids or with a maximum dose of prednisone of 15 mg/day.
Present complaints of vaginal dryness upon study entry.
Agreeing to participate in the protocol according to the informed consent form signed before study inclusion.

Key exclusion criteria (3 listed)

History of breast, uterine or ovarian neoplasia, history of thromboembolic events, heart, kidney or liver failure.
Other associated autoimmune rheumatic diseases, such as spondyloarthritis, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis and mixed connective tissue disease.
Conditions that may mimic SjD, such as history of head and neck radiation therapy, acquired immunodeficiency syndrome, hepatitis B and C, sarcoidosis, IgG4-related disease, and graft-versus-host disease.

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
Fractional CO2 laser (vaginal)Vaginal fractional CO2 laser applications will be performed once a month for three consecutive months.	Device	SjD with sicca vagintis complaints treated with vaginal fractional CO2 laser
Promestriene VaginalPatients in the group treated with promestriene will apply a 10 mg vaginal capsule at night for fifteen consecutive days and, after this period, one application every three days, until completing six months of treatment.	Drug	SjD with sicca vagintis complaints treated with topical promestriene

Primary outcome

Vaginal Health Index (VHI)
Time frame: Four and six months
To assess the improvement in the Vaginal Health Index (VHI) after treatment compared to the patient's baseline status in both arms. This score ranges from 5 (minimum) to 25 (maximum) and higher values indicate better outcomes.

7 secondary outcomes

6-Item version of the Female Sexual Function Index (FSFI)
Time frame: Four and six months
Primary Sjögren's Syndrome Quality of Life questionnaire (PSSQoL)
Time frame: Four and six months
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
Time frame: Four and six months
Visual analogue scale (VAS) of vaginal dryness symptoms
Time frame: Four and six months
Persistence of the beneficial effects of laser therapy - visual analogue scale (VAS) of vaginal dryness symptoms
Time frame: Six months
Incidence of treatment-emergent adverse events (safety and tolerability)
Time frame: One month, two months, three months, four months, five months, six months
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) (safety and tolerability)
Time frame: Four and six months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
Background: PubMed 11522151Abstracts of the International Continence Society 31st annual meeting. Seoul, Korea, 18-21 September 2001. Neurourol Urodyn. 2001;20(4):371-576. No abstract available.
Background: PubMed 15243675Tamanini JT, Dambros M, D'Ancona CA, Palma PC, Rodrigues Netto N Jr. [Validation of the "International Consultation on Incontinence Questionnaire -- Short Form" (ICIQ-SF) for Portuguese]. Rev Saude Publica. 2004 Jun;38(3):438-44. doi: 10.1590/s0034-89102004000300015. Epub 2004 Jul 8. Portuguese.
Background: PubMed 31344717Dall'Agno ML, Ferreira CF, Ferreira FV, Perez-Lopez FR, Wender MCO. Validation of the Six-item Female Sexual Function Index in Middle-Aged Brazilian Women. Rev Bras Ginecol Obstet. 2019 Jul;41(7):432-439. doi: 10.1055/s-0039-1692694. Epub 2019 Jul 25.
Background: PubMed 19968774Isidori AM, Pozza C, Esposito K, Giugliano D, Morano S, Vignozzi L, Corona G, Lenzi A, Jannini EA. Development and validation of a 6-item version of the female sexual function index (FSFI) as a diagnostic tool for female sexual dysfunction. J Sex Med. 2010 Mar;7(3):1139-46. doi: 10.1111/j.1743-6109.2009.01635.x. Epub 2009 Dec 1.
Background: PubMed 32044981van Nimwegen JF, van der Tuuk K, Liefers SC, Verstappen GM, Visser A, Wijnsma RF, Vissink A, Hollema H, Mourits MJE, Bootsma H, Kroese FGM. Vaginal dryness in primary Sjogren's syndrome: a histopathological case-control study. Rheumatology (Oxford). 2020 Oct 1;59(10):2806-2815. doi: 10.1093/rheumatology/keaa017.
Background: PubMed 25652072van Nimwegen JF, Arends S, van Zuiden GS, Vissink A, Kroese FG, Bootsma H. The impact of primary Sjogren's syndrome on female sexual function. Rheumatology (Oxford). 2015 Jul;54(7):1286-93. doi: 10.1093/rheumatology/keu522. Epub 2015 Feb 4.
Background: PubMed 27785888Shiboski CH, Shiboski SC, Seror R, Criswell LA, Labetoulle M, Lietman TM, Rasmussen A, Scofield H, Vitali C, Bowman SJ, Mariette X; International Sjogren's Syndrome Criteria Working Group. 2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts. Arthritis Rheumatol. 2017 Jan;69(1):35-45. doi: 10.1002/art.39859. Epub 2016 Oct 26.
Background: PubMed 24477727Serrano EV, Valim V, Miyamoto ST, Giovelli RA, Paganotti MA, Cade NV. Transcultural adaptation of the "EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)" into Brazilian Portuguese. Rev Bras Reumatol. 2013 Nov-Dec;53(6):483-93. doi: 10.1016/j.rbr.2013.04.003. English, Portuguese.
Background: PubMed 21345815Seror R, Ravaud P, Mariette X, Bootsma H, Theander E, Hansen A, Ramos-Casals M, Dorner T, Bombardieri S, Hachulla E, Brun JG, Kruize AA, Praprotnik S, Tomsic M, Gottenberg JE, Devauchelle V, Devita S, Vollenweider C, Mandl T, Tzioufas A, Carsons S, Saraux A, Sutcliffe N, Vitali C, Bowman SJ; EULAR Sjogren's Task Force. EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI): development of a consensus patient index for primary Sjogren's syndrome. Ann Rheum Dis. 2011 Jun;70(6):968-72. doi: 10.1136/ard.2010.143743. Epub 2011 Feb 22.
Background: PubMed 19561361Seror R, Ravaud P, Bowman SJ, Baron G, Tzioufas A, Theander E, Gottenberg JE, Bootsma H, Mariette X, Vitali C; EULAR Sjogren's Task Force. EULAR Sjogren's syndrome disease activity index: development of a consensus systemic disease activity index for primary Sjogren's syndrome. Ann Rheum Dis. 2010 Jun;69(6):1103-9. doi: 10.1136/ard.2009.110619. Epub 2009 Jun 28.
Background: PubMed 38714422Seganfredo IB, Bianchi C, Tacla M, Chedraui P, Haddad JM, Simoes R, Baracat EC, Soares JM Jr. Comparison of promestriene with vaginal fractional CO2 laser and radiofrequency treatments of genitourinary syndrome of menopause. Maturitas. 2024 Aug;186:108008. doi: 10.1016/j.maturitas.2024.108008. Epub 2024 Apr 24.
Background: PubMed 29726916Samuels JB, Garcia MA. Treatment to External Labia and Vaginal Canal With CO2 Laser for Symptoms of Vulvovaginal Atrophy in Postmenopausal Women. Aesthet Surg J. 2019 Jan 1;39(1):83-93. doi: 10.1093/asj/sjy087.
Individual participant dataSharing planned: No

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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.

Eloisa Bonfa, Full prof. contact

+55 11 30617492

eloisa.bonfa@hc.fm.usp.br

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. 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 Brazil. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eloisa Bonfa, Full prof. (+55 11 30617492, eloisa.bonfa@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vaginal Health Index (VHI) (time frame: Four and six months). 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 NCT07153276, which also lists 28 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 3 Mar 2026.