NCT04297319

Brief Summary

This study evaluates the efficacy and security of laser for atrophy treatment. Half of participants will receive the laser treatment and the other half placebo.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

September 20, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

1.6 years

First QC Date

November 5, 2019

Last Update Submit

August 5, 2022

Conditions

LasersAtrophy of VaginaAtrophy Vulva

Outcome Measures

Primary Outcomes (9)

  • Change from Baseline in Female Sexual Function Index questionnaire

    Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome

    baseline, and week 4 after treatment

  • Change from Baseline in Female Sexual Function Index questionnaire

    Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome

    baseline,and week 12 after treatment

  • Change from Baseline in Female Sexual Function Index questionnaire

    Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome

    baseline, and week 36 after treatment

  • Vaginal Cytology Improvement

    Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy

    baseline, and week 4 after treatment

  • Vaginal Cytology Improvement

    Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy

    baseline, and week 12 after treatment

  • Vaginal Cytology Improvement

    Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy

    baseline, and week 36 after treatment

  • Change in vaginal acidity measure

    the normal vaginal acidity is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)

    baseline, and week 4 after treatment

  • Change in vaginal acidity measure

    the normal vaginal acidity is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)

    baseline, and week 12 after treatment

  • Change in vaginal pH measure

    the normal vaginal ph is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)

    baseline,and week 36 after treatment

Secondary Outcomes (1)

  • Number of patient with Local Estrogen therapy requirement post intervention

    baseline,and week 48

Other Outcomes (1)

  • Number of participant with Adverse events reported in each visit

    Baseline,and week 48

Study Arms (2)

1 - Laser intervention

EXPERIMENTAL

Laser diiodo treatment, 3 procedures of 5-10 minutes at intervals of 4 weeks

Procedure: Laser diiodo

2 - Laser placebo

PLACEBO COMPARATOR

Only the laser speculum is placed in the vagina but the laser is not activated. 3 procedures of 5-10 minutes at intervals of 4 weeks

Procedure: Laser Placebo

Interventions

Laser diiodoPROCEDURE

3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks It is an outpatient procedure, not anesthesia required.

1 - Laser intervention
Laser PlaceboPROCEDURE

3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks. It is an outpatient procedure, not anesthesia required.

2 - Laser placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Menopause women with vulvovaginal symptoms of atrophy
  • No previous estrogen treatment for the last 30 days
  • Active sexual life (vaginal penetration)
  • Accept to participate
  • Pap atrophy or hypotrophy in the last year

You may not qualify if:

  • Vulvovaginal diseases
  • Abnormal uterine bleeding
  • Antidepressants drugs
  • Uncontrolled diabetes
  • Cervical intraepithelial lesions or cancer
  • Photosensitized or under treatment with photosensibilized drugs
  • Collagen diseases
  • Vulvovaginal infections in the last 15 days
  • Immunosuppressed patients or under immunosuppressed treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano de Buenos Aires

CABA, 1199, Argentina

Location

Related Publications (2)

  • Knight C, Logan V, Fenlon D. A systematic review of laser therapy for vulvovaginal atrophy/genitourinary syndrome of menopause in breast cancer survivors. Ecancermedicalscience. 2019 Dec 12;13:988. doi: 10.3332/ecancer.2019.988. eCollection 2019.

    PMID: 32010212BACKGROUND

  • Adabi K, Golshahi F, Niroomansh S, Razzaghi Z, Ghaemi M. Effect of the Fractional CO2 Laser on the Quality of Life, General Health, and Genitourinary Symptoms in Postmenopausal Women With Vaginal Atrophy: A Prospective Cohort. J Lasers Med Sci. 2020 Winter;11(1):65-69. doi: 10.15171/jlms.2020.11. Epub 2020 Jan 18.

    PMID: 32099629RESULT

Study Officials

  • claudia E Marchitelli, MD

    Hospital Italiano de Buenos Aires, Argentina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The patient and the outcomes assessor and principal investigator has not access to the randomization system
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double blind, randomized, control clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Gynecology department

Study Record Dates

First Submitted

November 5, 2019

First Posted

March 5, 2020

Study Start

September 20, 2019

Primary Completion

May 1, 2021

Study Completion

December 1, 2021

Last Updated

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)