Laser Vaginal Treatment for GSM

What this trial studies

Genitourinary Syndrome of Menopause (GSM) due to low estrogen levels affects about half of post-menopausal women and may have a dramatic impact on women's quality of life. Women complain of vaginal dryness, itching, discomfort, malodour, painful intercourse and may have urinary urgency, irritation, bladder/urethral pain and recurring bladder infections. First-line therapies include vaginal moisturizers, lubricants and estrogen (either oral or with vaginal cream/tablets). While these therapies are effective, the ongoing costs and the resistance to the indefinite use of vaginal creams/inserts is a challenge to the continued use of these therapies.

Conditions in scope

• Menopausal Urethral Atrophy
• Vulvar Atrophy

Interventions

• laser vaginal treatment (Procedure) — Er:YAG laser

Who can join

Women only · Ages 45 Years to 70 Years · Accepts healthy volunteers.

Inclusion criteria

• Females aged 45-70 years;
• or more years since last natural menstrual period, or surgical menopause (bilateral oophorectomy);
• at least 1 vaginal symptom reported from the following list, experienced for the past 30 days which is moderate or severe at least once a week: dryness \| itching \| irritation \| soreness/pain \| dyspareunia;
• no concurrent or new planned treatment for GSM during the treatment period and the 3 months following it;
• vaginal anatomy allows for laser therapy; 6) willing and able to comply with the study protocol.

Exclusion criteria

• Patient is pregnant/lactating
• unexplained abnormal genital bleeding
• current acute vaginal/ bladder infection
• antibiotic use the past 30 days;
• women under age 55 with endometrial ablation/ hysterectomy/ at least one ovary;
• concurrent use of any other new GSM treatment
• pelvic surgery \<3 months
• current treatment for chronic pelvic pain

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: 2019-08-01
• Primary completion: 2025-03-24
• Last update posted: 2026-04-27
• First posted: 2019-08-02

Sponsor & contact

Lead sponsor: Sunnybrook Health Sciences Centre (Other)

Collaborators: Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario

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

• subjective measure of change in: the patient's most bothersome symptom (Baseline and 3 months after treatment start)
  The most bothersome symptom of GSM (vaginal dryness, discomfort, itching, dyspareunia, urinary urgency, dysuria) will be identified and its severity rated on a standardized 4-point scale: 0=none, 1=mild, 2=moderate, 3=severe

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.