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Completed

NCT Number: NCT04039555

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

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.

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Key information

Conditions

Vaginal Atrophy

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Palacios

Madrid, 28009, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CO2 intimate

Device

Two sessions with CO2 intimate laser for vaginal symptoms treatment

Erbium-yag

Device

Two sessions with Erbium-yag laser for vaginal symptoms treatment

CO2 intimate or Erbium-yag

Device

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

Primary outcomes

  1. Comparation of 1 series of 2 treatment sessions with Erbium-Yag or intimate CO2RE vs Sham for the symptoms of vulvovaginal atrophy

    Time frame: 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 outcomes

  1. Differences between CO2RE and Erbium-Yag

    Time frame: 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).

  2. Changes in the Vulvar and Vaginal Health Index (VVHI)

    Time frame: Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)

    Analyzing the information registered in the visits performed

Sponsors and collaborators

Lead sponsor

Instituto Palacios

Other

Registry information

Official study title

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)

Acronym: COER

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 31, 2019
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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