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Procedure

laser treatment for Vulvar Atrophy

N/A
Recruiting
Led By Patricia Lee, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 months after treatment start
Awards & highlights

Study Summary

This trial will test how well a new laser therapy works to treat Genitourinary Syndrome of Menopause (GSM) in post-menopausal women.

Who is the study for?
This trial is for post-menopausal women aged 45-70 with Genitourinary Syndrome of Menopause (GSM), experiencing symptoms like vaginal dryness or pain. Participants must not be pregnant, have had recent pelvic surgery, or use other GSM treatments.Check my eligibility
What is being tested?
The study tests laser vaginal treatment's effectiveness on GSM symptoms compared to standard therapies. It's a randomized controlled trial, meaning participants are randomly assigned to receive either the laser treatment or a placebo/control condition.See study design
What are the potential side effects?
Potential side effects of the laser treatment may include discomfort during the procedure, mild swelling or redness afterwards, and a small risk of burns or scarring.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 months after treatment start
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 months after treatment start for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
subjective measure of change in: the patient's most bothersome symptom

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: laser treatmentActive Control1 Intervention
Group II: sham treatmentPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,248 Total Patients Enrolled
Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of OntarioUNKNOWN
1 Previous Clinical Trials
158 Total Patients Enrolled
Patricia Lee, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
2 Previous Clinical Trials
284 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the eligibility criteria for participation in this trial?

"This medical study is searching for 60 women aged 45-70 suffering from vulval atrophy. In addition to this, these potential patients must have not received any treatments for genitourinary syndrome of menopause in the past three months and need to be willing and able to comply with trial protocol. Lastly, participants must report experiencing at least one moderate or severe symptom such as dryness, itching, irritation pain/soreness or dyspareunia during the last 30 days at least once a week."

Answered by AI

What is the current participant capacity of this experiment?

"Affirmative. According to the information documented on clinicaltrials.gov, this medical experiment is in full swing and looking for participants. It was first advertised on August 1st 2019 with its most recent changes being made October 17th 2022. Sixty patients are needed from a single study site."

Answered by AI

Are there still opportunities for people to join this experiment?

"That is correct. According to the particulars of this trial hosted on clinicaltrials.gov, it began recruitment on August 1st 2019 and was most recently updated on October 17th 2022. The investigation requires a total of 60 volunteers from one location."

Answered by AI

Does the protocol of this clinical trial allow applicants who are younger than 80 years old to participate?

"The age window for this research project specifies a minimum of 45 years old and maximum of 70. However, there are also 42 studies that accommodate minors and 138 trials available to those over 65."

Answered by AI

Who else is applying?

What state do they live in?
Idaho
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Laser Vaginal Treatment for GSM
2019. "Laser Vaginal Treatment for GSM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04042766.
~11 spots leftby Apr 2025
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