Evaluation of fractional CO2 laser in vaginal atrophy in menopausal women compared to topical estrogen therapy

Phase 4

• Conditions: on-inflammatory disorder of vagina, unspecified; N89.9

• Registration Number: RBR-228fsy
• Lead Sponsor: niversidade Federal de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-25
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Age over 50 years;no menstruation 12 months ago; presence of symptoms resulting from vulvovaginal atrophy, a conventional Pap smear examination of Frost consistent with atrophic status and who have not undergone hormone replacement in last 3 months

Exclusion Criteria

urogenital infection or inflammation of character acute or recurrent;pre-neoplastic lesions;pelvic prolapses; pregnant women; immunosuppressive patients, severe chronic diseases; previous pelvic surgery;use of hormone therapy for less than 3 months;previous pelvic radiotherapy.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- increased cell proliferation through the evaluation of the FROST index and the measurement of thickness (Breslow's rule will be used) in the group of women undergoing lasertapia<br><br>;- increased vascular proliferation (through the evaluation of VEGF and Ki 67 reagents) in the group of women undergoing lasertapia

Secondary Outcome Measures

Name	Time	Method
- significant increase in cell and vascular proliferation in the group of women undergoing topical estrogen therapy