Vaginal AtrophyCOERNCT04039555
Clinical Study to Compare the Efficacy of Erbium-Yag Laser or CO2RE Intimate Laser With Sham (COER)
A study testing CO2 intimate, Erbium-yag and CO2 intimate or Erbium-yag in people with Vaginal Atrophy, run by Instituto Palacios at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Vaginal Atrophy
- What is being tested?
- CO2 intimate, Erbium-yag and CO2 intimate or Erbium-yag
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteSpain
- Study dates
- 24 Sep 2019to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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
- Conditions
- Vaginal Atrophy
- Being tested
- CO2 intimate, Erbium-yag, CO2 intimate or Erbium-yag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 intimateDevice
Two sessions with CO2 intimate laser for vaginal symptoms treatment
Erbium-yagDevice
Two sessions with Erbium-yag laser for vaginal symptoms treatment
CO2 intimate or Erbium-yagDevice
Two sessions of one of the two lasers with no therapeuthical energy
| Study group | Role | What they receive |
|---|---|---|
| Active Arm - CO2 intimate | Active comparator | Patients will receive 2 sessions of CO2 laser treatment, spaced 4 to 6 weeks apart Receives: Device: CO2 intimate |
| Active Arm - Erbium-yag | Active comparator | Patients will receive 2 sessions of Erbium-Yag laser treatment, spaced 4 to 6 weeks apart Receives: Device: Erbium-yag |
| Sham Arm | Sham comparator | Patients will receive 2 sessions of Erbium-Yag laser or CO2 laser treatment with non-therapeutic energy, spaced between 4 and 6 weeks apart Receives: Device: CO2 intimate or Erbium-yag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparation of 1 series of 2 treatment sessions with Erbium-Yag or intimate CO2RE vs Sham for the symptoms of vulvovaginal atrophy
Analyzing the differences in % the cytological maturity index, changes in the intensity of symptoms and PH range of normality (3,5- 4.5).
Measured: Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)
Secondary outcomes (2)
Differences between CO2RE and Erbium-Yag
Analyzing the differences in % the cytological maturity index, changes in the intensity of symptoms and PH range of normality (3,5- 4.5).
Measured: Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)
Changes in the Vulvar and Vaginal Health Index (VVHI)
Analyzing the information registered in the visits performed
Measured: Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start24 Sep 2019
- Primary completion31 Mar 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Palacios
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039555
- Sponsor's protocol ID
- COER
- Acronym
- COER
- Status last verified
- Feb 2021
- First submitted
- 22 Apr 2019
- Last updated
- 11 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04039555
- Acronym / sponsor ID
- COER / COER
- Conditions
- Vaginal Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Instituto PalaciosUniversity, hospital or other
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Arm - CO2 intimate | Active comparator | Device: CO2 intimatePatients will receive 2 sessions of CO2 laser treatment, spaced 4 to 6 weeks apart |
| Active Arm - Erbium-yag | Active comparator | Device: Erbium-yagPatients will receive 2 sessions of Erbium-Yag laser treatment, spaced 4 to 6 weeks apart |
| Sham Arm | Sham comparator | Device: CO2 intimate or Erbium-yagPatients will receive 2 sessions of Erbium-Yag laser or CO2 laser treatment with non-therapeutic energy, spaced between 4 and 6 weeks apart |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2 intimateTwo sessions with CO2 intimate laser for vaginal symptoms treatment | Device | Active Arm - CO2 intimate |
| Erbium-yagTwo sessions with Erbium-yag laser for vaginal symptoms treatment | Device | Active Arm - Erbium-yag |
| CO2 intimate or Erbium-yagTwo sessions of one of the two lasers with no therapeuthical energy | Device | Sham Arm |
Primary outcome
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).
2 secondary outcomes
Differences between CO2RE and Erbium-Yag
Time frame: Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 intimate, Erbium-yag and CO2 intimate or Erbium-yag in people with Vaginal Atrophy, run by Instituto Palacios at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.