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Completed

NCT Number: NCT02419729

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

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.

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Key information

Conditions

Vulvovaginal Atrophy

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Atencao a Saude da Mulher

São Bernardo do Campo, São Paulo, 09770-210, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CO2 laser

Device

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

Estrogen

Drug

Topical estrogen cream treatment: Estriol 1mg daily.

Other names: Estriol 1mg

Placebo of Estrogen

Drug

Placebo of topical estrogen cream.

Placebo of CO2 laser

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Faculdade de Medicina do ABC

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 17, 2015
Registry last updated
Jun 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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