NCT04111952

Brief Summary

Women previously treated with vaginal CO2 laser will receive an additional treatment 6 months after cessation of previous laser treatment or a sham laser treatment. The efficacy and safety of the additional treatment will be assessed.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
253

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2023

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

2.4 years

First QC Date

September 30, 2019

Last Update Submit

April 19, 2022

Conditions

Lax Vaginal Introitus

Outcome Measures

Primary Outcomes (1)

  • Length of effect

    The duration of symptom improvement.

    From the treatment session up to 6 months post-treatment

Secondary Outcomes (3)

  • Female sexual function index

    From the treatment session up to 6 months post-treatment

  • Sexual intercourse

    From the treatment session up to 6 months post-treatment

  • Urinary distress index

    From the treatment session up to 6 months post-treatment

Study Arms (2)

Additional laser treatment

EXPERIMENTAL

Women receiving a single laser treatment.

Device: CO2 laser

Sham laser treatment

SHAM COMPARATOR

Women receiving sham laser treatment.

Device: Sham laser

Interventions

CO2 laserDEVICE

A single session of CO2 vaginal laser treatment

Additional laser treatment
Sham laserDEVICE

A single session of sham laser treatment.

Sham laser treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previously treated with 3 laser treatments.
  • Clear PAP test from the last 3 years.

You may not qualify if:

  • Vaginal bleeding of unknown source.
  • Vaginal surgery in the past 9 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Interventions

Lasers, Gas

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Roy Lauterbach, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 2, 2019

Study Start

June 1, 2019

Primary Completion

November 1, 2021

Study Completion

January 28, 2023

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)