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

Clinical Study to Compare the Efficacy of 1 Series of 2 Treatment Sessions With Erbium-Yag Laser or CO2RE Intimate Laser vs Sham (Sham Treatment) for Vulvovaginal Atrophy (Dryness and / or Dyspareunia)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04039555

Acronym

COER

Enrollment

136

Registered

2019-07-31

Start date

2019-09-24

Completion date

2020-05-30

Last updated

2021-02-11

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

Conditions

Vaginal Atrophy

Brief summary

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.

Detailed 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

Interventions

DEVICECO2 intimate

Two sessions with CO2 intimate laser for vaginal symptoms treatment

DEVICEErbium-yag

Two sessions with Erbium-yag laser for vaginal symptoms treatment

DEVICECO2 intimate or Erbium-yag

Two sessions of one of the two lasers with no therapeuthical energy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Caregiver)

Masking description

It is a single blind study

Eligibility

Sex/Gender

FEMALE

Age

45 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Comparation of 1 series of 2 treatment sessions with Erbium-Yag or intimate CO2RE vs Sham for the symptoms of vulvovaginal atrophy	Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)	Analyzing the differences in % the cytological maturity index, changes in the intensity of symptoms and PH range of normality (3,5- 4.5).

Secondary

Measure	Time frame	Description
Differences between CO2RE and Erbium-Yag	Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)	Analyzing the differences in % the cytological maturity index, changes in the intensity of symptoms and PH range of normality (3,5- 4.5).
Changes in the Vulvar and Vaginal Health Index (VVHI)	Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)	Analyzing the information registered in the visits performed

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026