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

Study of vascular and cellular proliferation factor and mucous thickness in the vaginal epithelium in menopaused women submitted to vaginal rejuvenation by fractional co2 laser

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-228fsy
Enrollment
Unknown
Registered
2020-03-25
Start date
2018-02-06
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-inflammatory disorder of vagina, unspecified

Interventions

Topical estrogen therapy group - patients will be advised to apply 1g of vaginal cream (estriol 1mg / g) every night for 20 days and then weekly application for 4 consecutive months (20 patients) Las
Drug
Procedure/surgery

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Sex/Gender
Female
Age
50 Years to 60 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
- 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 ;- increased vascular proliferation (through the evaluation of VEGF and Ki 67 reagents) in the group of women undergoing lasertapia

Secondary

MeasureTime frame
- significant increase in cell and vascular proliferation in the group of women undergoing topical estrogen therapy

Countries

Brazil

Contacts

Public ContactPaula Pallone Dutra

Universidade Federal de São Paulo

paula.pallone@yahoo.com.br55-011-982159011

Outcome results

None listed

Source: REBEC (via WHO ICTRP)