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NCT04042766
Laser Vaginal Treatment for GSM
NA trial testing laser vaginal treatment in Menopausal Urethral Atrophy in 60 participants. Status unknown.
1 March 2024
Quick facts
| Lead sponsor | Sunnybrook Health Sciences Centre |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 August 2019 |
| Primary completion | 1 March 2024 |
| Estimated completion | 1 March 2026 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- laser vaginal treatment
Conditions studied
- Menopausal Urethral Atrophy — all drugs for Menopausal Urethral Atrophy →
- Vulvar Atrophy — all drugs for Vulvar Atrophy →
Sponsor
Sunnybrook Health Sciences Centre — full company profile →
Who can join
Adults 45 to 70, female only, with Menopausal Urethral Atrophy or Vulvar Atrophy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04042766
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04042766 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sunnybrook Health Sciences Centre
- Last refreshed: 15 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04042766.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing