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NCT Number: NCT07420647

Pilot Study of Individualized Treatment for Genitourinary Syndrome of Menopause in Women After Cancer Treatment

This pilot study is designed to evaluate an individualized approach to the treatment of genitourinary syndrome of menopause (GSM) in women who have undergone oncological treatment. GSM is a common condition in postmenopausal women and may include symptoms such as vaginal dryness, irritation, pain during intercourse, and urinary discomfort. These symptoms can significantly affect quality of life and sexual function, particularly in women after cancer treatment.

The purpose of this study is to assess whether a personalized, non-hormonal treatment approach can effectively reduce GSM symptoms and improve overall quality of life and sexual function in this patient population. Participants will be assigned to an intervention group or a control group and will be followed prospectively over time.

The study will include women in menopause who have completed oncological treatment and experience symptoms of GSM. Clinical assessments, patient-reported outcomes, and quality-of-life questionnaires will be used to evaluate treatment effectiveness and safety.

The results of this pilot study may help inform future clinical practice and support the development of individualized, non-hormonal treatment strategies for women with GSM after cancer treatment.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Genitourinary Syndrome of Menopause (GSM) Female Cancer Survivors Menopause Vaginal Dryness

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Female sex.

Postmenopausal women.

History of oncological treatment (e.g., gynecological or other malignancies).

Presence of genitourinary syndrome of menopause (GSM), including symptoms such as vaginal dryness, dyspareunia, burning, irritation, or urinary symptoms.

Completion of primary oncological treatment prior to enrollment.

Age ≥ 18 years.

Ability to understand the study procedures and provide written informed consent

Exclusion criteria

Current pregnancy or premenopausal status.

Active malignant disease requiring ongoing oncological treatment.

Acute genital or urinary tract infection at the time of enrollment.

Prior participation in another interventional clinical study that could influence study outcomes.

Known hypersensitivity or contraindication to study-related interventions.

Any medical or psychiatric condition that, in the investigator's opinion, would interfere with study participation or outcome assessment.

Treatment and study plan

Non-ablative vaginal Er:YAG laser therapy

Device

Non-ablative vaginal erbium-doped yttrium aluminum garnet (Er:YAG) laser therapy administered for the treatment of genitourinary syndrome of menopause. The intervention consists of three vaginal laser treatments performed at four-week intervals, using standardized laser parameters, without tissue ablation. The procedure is conducted in an outpatient setting.

Standard care

Other

Standard conservative management according to institutional clinical practice guidelines for genitourinary syndrome of menopause, without laser-based intervention.

Primary outcomes

  1. Severity of Genitourinary Syndrome of Menopause (GSM) Symptoms

    Time frame: Baseline

    The primary outcome is the change in severity of genitourinary syndrome of menopause (GSM) symptoms following individualized treatment in women after oncological treatment. Symptom severity will be assessed using validated clinical and patient-reported outcome measures, including vaginal dryness, dyspareunia, irritation, and urinary symptoms. Changes will be evaluated by comparing baseline measurements with post-intervention assessments.

  2. Change in Severity of Genitourinary Syndrome of Menopause (GSM) Symptoms

    Time frame: Throughout study completion: 3 times, every 4 weeks

    The primary outcome is the change in severity of genitourinary syndrome of menopause (GSM) symptoms following individualized treatment in women after oncological treatment. Symptom severity will be assessed using validated clinical and patient-reported outcome measures, including vaginal dryness, dyspareunia, irritation, and urinary symptoms. Changes will be evaluated by comparing baseline measurements with post-intervention assessments.

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Official study title

The Pilot Project on Individualized Treatment of Genitourinary Syndrome of Menopause in Women After Oncological Treatment: A Prospective Interventional Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2026
Registry last updated
Feb 19, 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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