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NCT Number: NCT07153276

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

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.

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Key information

Conditions

Sjogren Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Primary Sjogren Syndrome Rheumatic Diseases Salivary Gland Diseases Sjogren Disease Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Sao Paulo General Hospital

São Paulo, Brazil

Location status: Recruiting

Location contact

Eloisa Bonfa, Full professor

CONTACT

[email protected]

+55 11 30617492

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Fractional CO2 laser (vaginal)

Device

Vaginal fractional CO2 laser applications will be performed once a month for three consecutive months.

Promestriene Vaginal

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 6-Item version of the Female Sexual Function Index (FSFI)

    Time frame: Four and six months

    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.

  2. Primary Sjögren's Syndrome Quality of Life questionnaire (PSSQoL)

    Time frame: Four and six months

    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.

  3. International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)

    Time frame: Four and six months

    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.

  4. Visual analogue scale (VAS) of vaginal dryness symptoms

    Time frame: Four and six months

    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.

  5. Persistence of the beneficial effects of laser therapy - visual analogue scale (VAS) of vaginal dryness symptoms

    Time frame: Six months

    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.

  6. Incidence of treatment-emergent adverse events (safety and tolerability)

    Time frame: One month, two months, three months, four months, five months, six months

    To assess the incidence of treatment-emergent adverse events (as a percentage) in the two arms of the study.

  7. EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) (safety and tolerability)

    Time frame: Four and six months

    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.

Other outcomes

  1. Histological analysis of vaginal wall biopsies before and after treatment

    Time frame: Six months

    To evaluate the improvement of histological parameters in the tissue samples from vaginal wall biopsies before and after treatment in the two arms of the study. An experienced pathologist will blindly evaluate the tissue samples from vaginal wall biopsies before and after interventions in both study arms. This pathologist will report their subjective assessment of improvement (increase) (yes or no) in epithelial thickness, collagen fibers (percentage of collagen types I and III), and/or microvascularization (weak, moderate and intense).

Study contacts

Contact information is provided by the study sponsor or research team.

Eloisa Bonfa, Full prof.

CONTACT

[email protected]

+55 11 30617492

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Acronym: VaLS

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Sep 3, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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