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

What this trial studies

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.

Conditions in scope

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

Interventions

• 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…
• Non-ablative vaginal Er:YAG laser therapy (Device) — Non-ablative vaginal 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…
• Standard care (Other) — Standard conservative management according to institutional clinical practice guidelines for genitourinary syndrome of menopause, without laser-based intervention.

Who can join

Women only · Ages 18 Years and up

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2024-10-15
• Primary completion: 2027-10-01
• Last update posted: 2026-02-19
• First posted: 2026-02-19

Sponsor & contact

Lead sponsor: Institute of Oncology Ljubljana (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

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

Related ClearedRx care

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