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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039555
Recruitment Status : Not yet recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Instituto Palacios

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.

Condition or disease Intervention/treatment Phase
Vaginal Atrophy Device: CO2 intimate Device: Erbium-yag Device: CO2 intimate or Erbium-yag Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: It is a single blind study
Primary Purpose: Treatment
Official 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)
Estimated Study Start Date : September 24, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active Arm - CO2 intimate
Patients will receive 2 sessions of CO2 laser treatment, spaced 4 to 6 weeks apart
Device: CO2 intimate
Two sessions with CO2 intimate laser for vaginal symptoms treatment

Active Comparator: Active Arm - Erbium-yag
Patients will receive 2 sessions of Erbium-Yag laser treatment, spaced 4 to 6 weeks apart
Device: Erbium-yag
Two sessions with Erbium-yag laser for vaginal symptoms treatment

Sham Comparator: Sham Arm
Patients will receive 2 sessions of Erbium-Yag laser or CO2 laser treatment with non-therapeutic energy, spaced between 4 and 6 weeks apart
Device: CO2 intimate or Erbium-yag
Two sessions of one of the two lasers with no therapeuthical energy




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039555


Contacts
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Contact: Santiago Palacios, PhD +34 91 578 05 17 ipalacios@institutopalacios.com
Contact: Eva Soler, SC +34 91 578 05 17 eva.maria.soler@institutopalacios.com

Locations
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Spain
Instituto Palacios
Madrid, Spain, 28009
Sponsors and Collaborators
Instituto Palacios
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Responsible Party: Instituto Palacios
ClinicalTrials.gov Identifier: NCT04039555    
Other Study ID Numbers: COER
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical