Co2 Laser Treatment

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

Co2 Laser Treatment [NCT02419729]

Description: 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.

Device: CO2 laser; Drug: Estrogen; Drug: Placebo of Estrogen; Device: Placebo of CO2 laser

Primary Investigator: Karram

Drug/Device Information
To assess safety and efficacy of the Fractional CO2 laser (SmartXide2) for the treatment of vulvovaginal atrophy
Non randomized
Qualified subjects will receive a total of three treatments
El.En SpA
Major Inclusion and Exclusion
Age 45 to 60 healthy non-smoking post menopausal women with absence of menstruation of at least 12 months
Exhibiting vulvovaginal atrophy symptoms and prolapse staged < II
No acute/recurrent UTI OR vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months
No thrombophlebitis, heart failure or antiplatelets, anticoagulants, thrombolytics, vitamin E, anti inflammatories 2 weeks pre treatment