Evaluation of Fractional CO2 Laser Treatment Efficacy and Comparison to Vaginal Estrogen Therapy in Postmenopausal Women With Vulvovaginal Atrophy
Condition: Vulvovaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

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.
    

Intervention name(s): CO2 laser; Estrogen; Placebo of Estrogen; Placebo of CO2 laser
Intervention type(s): Device; Drug; Drug; Device
Intervention description(s): 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); Topical estrogen cream treatment: Estriol 1mg daily.; Placebo of topical estrogen cream.; 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 intervention name(s): Fractionated CO2 laser; Estriol 1mg; SMARTXIDE2 V2LR - Monalisa Touch - Deka Laser
Intervention MeSH terms: Estrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vulvovaginal atrophy; Menopause; Fractional CO2 laser; Estrogen cream