Last reviewed · How we verify
NCT02691936: VeLVET
A Randomized Clinical Trial Comparing Vaginal Laser Therapy to Vaginal Estrogen Therapy in Women With Genitourinary Syndrome of Menopause
NA trial testing CO2 fractionated vaginal laser in Atrophic Vaginitis in 69 participants. Completed in 1 December 2018.
1 December 2018
Quick facts
| Lead sponsor | The Cleveland Clinic |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 69 |
| Start date | 1 March 2016 |
| Primary completion | 1 December 2018 |
| Estimated completion | 1 December 2018 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- CO2 fractionated vaginal laser
- Estrogens, Conjugated (USP) — full drug profile →
Conditions studied
- Atrophic Vaginitis — all drugs for Atrophic Vaginitis →
- Menopause — all drugs for Menopause →
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.
-
Vaginal Dryness
Time frame: 6 months
Vaginal dryness was assessed using a score of 0 (minimum) and 10 (maximum) on a Visual Analog Scale (VAS). Data presented is the mean difference before and after treatment. A higher mean difference signifies that the vaginal dryness score decreased to a greater measure hence resulting in a better outcome.
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):
-
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
Verify or expand the search:
- PubMed search for NCT02691936
- 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 NCT02691936 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Cleveland Clinic
- Last refreshed: 16 October 2019
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing