Evaluation of Fractional CO2 Laser Treatment Efficacy and Comparison to Vaginal Estrogen Therapy in Postmenopausal Women With Vulvovaginal Atrophy

June 24, 2016 updated by: Vera Lucia, Faculdade de Medicina do ABC
Forty-five women will be included in a double-blind randomized trial in order to compare fractional CO2 laser treatment, local estrogen therapy and the combination of both treatments for Vulvovaginal Atrophy (VVA) and determine the efficacy and possible adverse effects CO2 laser treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vulvovaginal atrophy (VVA) symptoms are strongly associated with declining ovarian function and estrogen levels in postmenopausal women, having a considerable impact on women's life quality. Topical hormonal therapy and hormonal replacement are widely used to alleviate VVA symptoms. In this context, minimal invasive fractional CO2 laser emerges as an alternative non-hormonal therapy, especially in patients that present contraindications to hormonal therapy. Objective: Compare fractional CO2 laser treatment, local estrogen therapy and the combination of both treatments for VVA and determine the efficacy and possible adverse effects CO2 laser treatment. Materials and Methods: Forty-five postmenopausal women will be randomized in three double-blinded groups of treatment consisting of CO2 laser and placebo of estrogen vaginal cream, placebo of CO2 laser and estrogen vaginal cream and CO2 laser and estrogen vaginal cream. Assessment of baseline characteristics and follow-up will be obtained through self-completion questionnaires (Female Sex Function Index, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), Vulvovaginal Symptom Questionnaire and The Menopause-Specific Quality of Life (MENQOL)). Frost Index and Vaginal Health Index (VHI) are part of objective clinical and histologic analyses. Colposcopy, vaginal cytology and middle third lateral vaginal wall biopsy will also be performed at baseline and at week 17.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Sao Bernardo, Sao Paulo, Brazil, 09770-210
        • Centro de Atencao a Saude da Mulher

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 45-65 women with amenorrhea for over 24 months.
  • Clinical vaginal atrophy diagnosis.

Exclusion Criteria:

  • BMI > 35.
  • Previous use of oral estrogen therapy in the last 6 months.
  • History or current diagnosis of cancer.
  • Altered cervical smear in the last 12 months.
  • Renal or hepatic insufficiency.
  • Drug-induced menopause.
  • Previous use of steroids.
  • Previous vaginal radiotherapy therapy.
  • Vulvovaginitis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CO2 laser & Estrogen
Effective fractional CO2 laser therapy and effective estrogen vaginal cream
Device: CO2 laser
SMARTXIDE2 V2LR (DEKA-Pulse) was used in each application using minimal parameters suggested by the laser's software ( Power of 30 W, 1000us emission time, 1000um spacing and a level of SmartStack 2)
Other Names:
  • Fractionated CO2 laser
Drug: Estrogen
Topical estrogen cream treatment: Estriol 1mg daily.
Other Names:
  • Estriol 1mg
Active Comparator: CO2 laser & Placebo of Estrogen
Effective fractional CO2 laser therapy and placebo of estrogen vaginal cream.
Device: CO2 laser
SMARTXIDE2 V2LR (DEKA-Pulse) was used in each application using minimal parameters suggested by the laser's software ( Power of 30 W, 1000us emission time, 1000um spacing and a level of SmartStack 2)
Other Names:
  • Fractionated CO2 laser
Drug: Placebo of Estrogen
Placebo of topical estrogen cream.
Sham Comparator: Placebo of CO2 laser & Estrogen
Placebo fractional CO2 laser therapy and effective estrogen vaginal cream.
Drug: Estrogen
Topical estrogen cream treatment: Estriol 1mg daily.
Other Names:
  • Estriol 1mg
Device: Placebo of CO2 laser
SMARTXIDE2 V2LR (DEKA-Pulse) was used in each applications using minimal parameters suggested by the laser's software but power of 0.5 W was stipulated for the placebo intervention and other parameters remained unchanged.
Other Names:
  • SMARTXIDE2 V2LR - Monalisa Touch - Deka Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Vulvovaginal Symptom Questionnaire
Time Frame: Baseline, week 10 and week 17
Vulvovaginal Symptom Questionnaire will be used to evaluate improvement of vulvovaginal atrophy symptoms.
Baseline, week 10 and week 17

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal Cytology Improvement
Time Frame: Baseline, week 10 and week 17
Vaginal cytology will be obtained from the middle third lateral vaginal wall in order to evaluate initial conditions of the vaginal wall and modifications after treatment. Frost Index, Karyopyknotic Index and Eosinophilic Index will be applied to each sample to measure improvement of vaginal atrophy.
Baseline, week 10 and week 17
Change from Baseline in Female Sex Function Index
Time Frame: Baseline, week 10 and week 17
Female Sex Function Index will be used to evaluate improvement of vulvovaginal atrophy symptoms.
Baseline, week 10 and week 17
Change from Baseline in The Menopause-Specific Quality of Life
Time Frame: Baseline, week 10 and week 17
The Menopause-Specific Quality of Life will be used to evaluate improvement of vulvovaginal atrophy symptoms.
Baseline, week 10 and week 17

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Incontinence Improvement
Time Frame: Baseline, week 10 and week 17
Incontinence Questionnaire-Short Form (ICIQ-SF) will be used in order to evaluate urinary incontinence improvement after treatment.
Baseline, week 10 and week 17
Vaginal Health Index Improvement
Time Frame: Baseline, week 10 and week 17
Evaluation of vaginal wall conditions such as pH, elasticity, bleeding signs, secretion type and consistency and hydration.
Baseline, week 10 and week 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculdade de Medicina do ABC

Investigators

  • Principal Investigator: Vera L da Cruz, MD, Faculdade de Medicina do ABC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

April 6, 2015

First Submitted That Met QC Criteria

April 14, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Estimate)

June 28, 2016

Last Update Submitted That Met QC Criteria

June 24, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39495014.0.0000.0082

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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