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OpenTrials
Active, Not Recruiting

NCT Number: NCT04042766

Laser Vaginal Treatment for GSM

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Menopausal Urethral Atrophy Vulvar Atrophy

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre, University of Toronto

Toronto, Ontario, M4N 3M5, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Females aged 45-70 years;
  • 2 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

Treatment and study plan

laser vaginal treatment

Procedure

Er:YAG laser

Primary outcomes

  1. subjective measure of change in: the patient's most bothersome symptom

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

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

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2027
First posted
Aug 2, 2019
Registry last updated
Apr 27, 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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