NCT03738605

Brief Summary

This study evaluates the efficacy of vaginal CO2 laser therapy in breast cancer survivors with symptoms of Genitourinary Syndrome of Menopause. Half of participants will receive active laser therapy, while the other half placebo therapy.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

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

First Submitted

Initial submission to the registry

November 6, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

1.5 years

First QC Date

November 6, 2018

Last Update Submit

July 28, 2019

Conditions

Genitourinary Syndrome of MenopauseVaginal AtrophyBreast CancerDyspareunia

Outcome Measures

Primary Outcomes (1)

  • 10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness

    It is a straight line with 2 endpoints "0" and "10". Zero defines "no dyspareunia at all" and "no dryness at all" , while 10 "dyspareunia as bad as it could be" and "dryness as bad as it could be". Participants will draw a line at or between the 2 end points. The distance between zero and drawn line will define the intensity of dyspareunia and dryness

    Change from baseline at 1 month post-treatment

Secondary Outcomes (15)

  • 3 days voiding diary

    Change from baseline at 1 month post-treatment

  • Day-to Day Impact of vaginal aging questionnaire (DIVA)

    Change from baseline at 1 month post-treatment

  • Patients Global Impression of Improvement

    At 1-month post-treatment

  • 10-centimeter Visual Analogue Scale assessing intensity of itching, burning and dysuria

    Change from baseline at 1 month post-treatment

  • King's Health Questionnaire (KHQ)

    Change from baseline at 1 month post-treatment

  • +10 more secondary outcomes

Study Arms (2)

Laser Group

EXPERIMENTAL

Microablative Fractional CO2 Laser Therapy (The parameters that will be used are the following: 1) Power: 30 ή 40 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter from 1-3 depending on the treatment status, 5) D-pulse mode.)

Device: Microablative Fractional CO2 Laser Therapy

Placebo

PLACEBO COMPARATOR

Placebo therapy (The parameters that will be used are the following: 1) Power: 0.5 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter 1, 5) Smart-pulse mode.

Device: Microablative Fractional CO2 Laser Therapy

Interventions

Microablative Fractional CO2 Laser TherapyDEVICE

5 laser therapies intravaginally administered will be applied at monthly intervals.

Also known as: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy
Laser GroupPlacebo

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • breast cancer history
  • dyspareunia
  • dryness

You may not qualify if:

  • Active genital infection (i.e herpes, vaginitis)
  • Prolapse stage \>=2
  • Underlying pathologies that could interfere with the protocol compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urogynecological Unit of Alexandra Hospital

Athens, 11528, Greece

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsDyspareunia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Stavros Athanasiou, Associate Proffesor

    National and Kapodistrian University of Athens, Greece

    STUDY DIRECTOR

Central Study Contacts

Stavros Athanasiou, Associate Professor

CONTACT

+306944478555stavros.athanasiou@gmail.com

Athanasios Douskos, MD

CONTACT

+306972845524thanosddoc@yahoo.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 6, 2018

First Posted

November 13, 2018

Study Start

December 1, 2018

Primary Completion

June 1, 2020

Study Completion

August 1, 2020

Last Updated

July 30, 2019

Record last verified: 2019-07

Locations

GR(1)