MedTrace Logo

Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy

NCT02085980 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-06-04

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to assess the safety and the efficacy of a laser in the treatment of vulvovaginal atrophy (VVA), that is to assess the change in the severity of the vaginal dryness symptom, by means of a visual analogic scale (10 cm VAS).

Conditions

  • Vulvovaginal Atrophy

Interventions

DEVICE

Laser treatment

The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece

Sponsors & Collaborators

  • The Christ Hospital

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • El. En. SpA

    lead INDUSTRY

Principal Investigators

  • Mickey Karram, MK · Hospital Physician, The Christ Hospital

  • Eric Sokol, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-08-31
Completion
2015-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02085980 on ClinicalTrials.gov