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NCT02691936: VeLVET

A Randomized Clinical Trial Comparing Vaginal Laser Therapy to Vaginal Estrogen Therapy in Women With Genitourinary Syndrome of Menopause

Completed NA Results posted Last updated 16 October 2019
What this trial tests

NA trial testing CO2 fractionated vaginal laser in Atrophic Vaginitis in 69 participants. Completed in 1 December 2018.

Timeline
1 March 2016
Primary endpoint
1 December 2018
1 December 2018

Quick facts

Lead sponsorThe Cleveland Clinic
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment69
Start date1 March 2016
Primary completion1 December 2018
Estimated completion1 December 2018
Sites6 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

The Cleveland Clinic

Who can join

Eligibility, female only, with Atrophic Vaginitis or Menopause. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

This is a multi-centered, randomized prospective single blinded clinical trial comparing CO2 fractionated vaginal laser therapy and vaginal estrogen cream therapy in the treatment of vulvovaginal atrophy/GSM.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Energy-based interventions for genitourinary syndrome of menopause: a systematic review of randomized controlled trials and prospective observational studies.
    Zerzan NL, Greer N, Ullman KE, Sowerby C, et al · · 2025 · cited 2× · PMID 39774067 · DOI 10.1097/gme.0000000000002465

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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/NCT02691936.

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