Image

Laser Vaginal Treatment for GSM

Laser Vaginal Treatment for GSM

Not Recruiting
45-70 years
Female
Phase N/A

Powered by AI

Overview

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. Recently, an innovative laser therapy has been used to treat women with GSM. A randomized controlled trial (RCT) to study how effective the laser is to treat women with GSM is planned.

Eligibility

Inclusion Criteria:

  1. Females aged 45-70 years;
  2. 2 or more years since last natural menstrual period, or surgical menopause (bilateral oophorectomy);
  3. 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;
  4. no concurrent or new planned treatment for GSM during the treatment period and the 3 months following it;
  5. vaginal anatomy allows for laser therapy; 6) willing and able to comply with the study protocol.

Exclusion Criteria:

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

Study details
    Menopausal Urethral Atrophy
    Vulvar Atrophy

NCT04042766

Sunnybrook Health Sciences Centre

30 March 2026

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.