NCT02419729View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

October 31, 2015

Study Completion Date

November 30, 2015

Conditions
Vulvovaginal Atrophy
Interventions
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)

DRUG

Estrogen

Topical estrogen cream treatment: Estriol 1mg daily.

DRUG

Placebo of Estrogen

Placebo of topical estrogen cream.

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.

Trial Locations (1)

09770-210

Centro de Atencao a Saude da Mulher, São Bernardo do Campo

All Listed Sponsors
lead

Faculdade de Medicina do ABC

OTHER

NCT02419729 - Evaluation of Fractional CO2 Laser Treatment Efficacy and Comparison to Vaginal Estrogen Therapy in Postmenopausal Women With Vulvovaginal Atrophy | Biotech Hunter | Biotech Hunter