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

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Faculdade de Medicina do ABC
• Treatments: Estrogens

Criteria

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.