Clinical Study to Compare the Efficacy of Erbium-Yag Laser or CO2RE Intimate Laser With Sham (COER)

Instituto Palacios

Status: Completed

Conditions: Vaginal Atrophy

Treatments: Device: CO2 intimate; Device: CO2 intimate or Erbium-yag; Device: Erbium-yag

Study type: Interventional

Funder types: Other

Identifiers

NCT04039555

COER

Details and patient eligibility

About

This trial compares the efficacy of two different laser treatments for vaginal atrophy symptoms between them and with sham treatment. Patients will be randomized to one of the two lasers or sham treatment.

Full description

Patients over 45 years of age with one or more AVV symptoms who wish to participate in the study will be included, 2 laser sessions spaced one of another 4-6 weeks, and final tracking visit 4-6 weeks of the last laser session.

Each patient shall be randomly assigned an arm of tto, with laser CO2, or laser Erbium, or sham group

Enrollment: 136 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women older than 45 years with at least one year of amenorrhea and at least one symptom of vulvovaginal atrophy of moderate and / or severe intensity.

Exclusion criteria

• Hormone treatment in the last three months for vulvovaginal atrophy
• Treatment with vaginal moisturizers in the last week for vulvovaginal atrophy
• Laser treatment in the last 12 months.
• Acute and recurrent infections of the urinary tract in the last 3 months.
• Acute genital infections
• Vaginal prolapse
• Alterations in the area to be treated, such as lacerations, abrasions or ulcers (time of resolution at medical discretion)
• Chronic decompensated noncommunicable diseases
• Women who are pregnant or have given birth in the last 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 3 patient groups

Active Arm - CO2 intimate

Active Comparator group

Description:

Patients will receive 2 sessions of CO2 laser treatment, spaced 4 to 6 weeks apart

Treatment:

Device: CO2 intimate

Active Arm - Erbium-yag

Active Comparator group

Description:

Patients will receive 2 sessions of Erbium-Yag laser treatment, spaced 4 to 6 weeks apart

Treatment:

Device: Erbium-yag

Sham Arm

Sham Comparator group

Description:

Patients will receive 2 sessions of Erbium-Yag laser or CO2 laser treatment with non-therapeutic energy, spaced between 4 and 6 weeks apart

Treatment:

Device: CO2 intimate or Erbium-yag