Post Menopausal Vaginal AtrophyNCT06726746
Efficacy of Fractional CO2 Laser Treatment in Post-Menopausal Women With Vaginal Atrophy
A study testing Fractional CO2 laser in people with Post Menopausal Vaginal Atrophy, run by Cairo University at 1 site in Egypt.
Trial summary
Vaginal dryness, itching, burning, irritability, secretion, and various urinary problems are the symptoms of vulvovaginal atrophy. Therefore, more attention must be paid to relieve these symptoms in order to provide better sexual health for postmenopausal women. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Post Menopausal Vaginal Atrophy
- What is being tested?
- Fractional CO2 laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Menopausal women whose ages ranged from 45 to 65 years.
- Sexually active
- Had symptoms of VVA (vaginal dryness, irritation, soreness, or dyspareunia)
Who cannot join
- Any history of hormonal therapy within the past 6 months
- Vaginal moisturizer or lubricant applications within the past 30 days
- Acute/recurrent urinary tract infection
- Active genital infection
- Prolapse stage II or more based on examination
- Psychiatric disorders
- Undiagnosed vaginal bleeding
- Any serious disease or chronic condition that could interfere with study compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Vaginal dryness, itching, burning, irritability, secretion, and various urinary problems are the symptoms of vulvovaginal atrophy. Therefore, more attention must be paid to relieve these symptoms in order to provide better sexual health for postmenopausal women. At present, an accumulating body of evidence suggests safety and efficacy of laser and energy-based devices for the treatment of women's genitourinary conditions. More clinical studies are needed to assess the safety profile and clinical outcomes of the lasers and energy-based devices to treat the symptoms associated with vulvovaginal atrophy (VVA)
Read the detailed description
This is a prospective, investigational study that will be performed in private outpatient clinic on 30 participants.
All participants will be scheduled for four visits (V1, V2, V3, and V4) with a 4- week interval where they will receive the interventions in the first three visits (V1, V2, and V3), While in the last visit (V4), the study will assess the participants' satisfaction with the treatment and any adverse events they experienced during the study period.
Detailed medical history of all participants will be collected including age, age at menopause, parity, type of delivery, history of vaginal reconstructive surgery, history of hormonal treatment, and sexual activity status.
At each visit (V1, V2, V3, and V4), the participants will be interviewed to assess Vaginal Health Index using the VHI score and assess the changes in the Female Sexual Function Index FSFI.
Signs of vaginal atrophy will be evaluated during pelvic examination After pelvic examination and completion of the questionnaire, the interventions will be performed.
The participants will receive the interventions in the first three visits (V1, V2, and V3).While in the last visit (V4), the study will assess the participants' satisfaction with the treatment and any adverse events they experienced during the study period.
The Procedures will be performed in private outpatient clinic. The participants will receive the intervention by using the CO2 laser machine. Using the following settings with the internal handpiece: square pattern with Deep Mode, fractional density of 5% and energy level of 50 mJ and fluence of 283 J/cm2. The handpiece will be inserted into the vagina (up to 10 cm) The handpiece will be positioned with contact to the vagina and will be rotated to apply 12 pulses at each 1-cm marking (application of laser energy at 3-10-cm depths) until the distal end of the vaginal probe reaches the introitus.
The laser application will be performed on an outpatient basis without local anesthesia in outpatient clinic.
Participants will be advised to avoid sexual intercourse or intravaginal devices for at least 3 days after the procedure owing to transient local inflammation at the vaginal mucosa generated by the laser application.
- Conditions
- Post Menopausal Vaginal Atrophy
- Being tested
- Fractional CO2 laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional CO2 laserDevice
. Using the following settings with the internal handpiece: square pattern with Deep Mode, fractional density of 5% and energy level of 50 mJ and fluence of 283 J/cm2. The handpiece will be inserted into the vagina (up to 10 cm) The handpiece will be positioned with contact to the vagina and will be rotated to apply 12 pulses at each 1-cm marking (application of laser energy at 3-10-cm depths) until the distal end of the vaginal probe reaches the introitus.
The laser application will be performed on an outpatient basis without local anesthesia in outpatient clinic.
| Study group | Role | What they receive |
|---|---|---|
| intervention by using the Fractional CO2 laser | Experimental | . Using the following settings with the internal handpiece: square pattern with Deep Mode, fractional density of 5% and energy level of 50 mJ and fluence of 283 J/cm2. The handpiece will be inserted into the vagina (up to 10 cm) The handpiece will be positioned with contact to the vagina and will be rotated to apply 12 pulses at each 1-cm marking (application of laser energy at 3-10-cm depths) until the distal end of the vaginal probe reaches the introitus.
The laser application will be performed on an outpatient basis without local anesthesia in outpatient clinic. Receives: Device: Fractional CO2 laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Vulvovaginal Symptoms Questionnaire (VVSQ)
Measured: 4-6 months
The Vaginal Health Index VHI assessment.
Measured: 4-6 months
Secondary outcomes (3)
Urogenital Distress Short Form (UDI-6
Measured: 4-6 months
Incontinence Impact Questionnaire Short Form (IIQ-7)
Measured: 4-6 months
Female Sexual Function Index (FSFI)
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Oct 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Menopausal Vaginal AtrophyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Onsi Anis, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726746
- Sponsor's protocol ID
- 1000
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fractional CO2 Laser Treatment in Post-Menopausal Women With Vaginal Atrophy
- ClinicalTrials.gov ID
- NCT06726746
- Acronym / sponsor ID
- 1000
- Conditions
- Post Menopausal Vaginal Atrophy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 10 Dec 2024 (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.
Vaginal dryness, itching, burning, irritability, secretion, and various urinary problems are the symptoms of vulvovaginal atrophy. Therefore, more attention must be paid to relieve these symptoms in order to provide better sexual health for postmenopausal women. At present, an accumulating body of evidence suggests safety and efficacy of laser and energy-based devices for the treatment of women's genitourinary conditions. More clinical studies are needed to assess the safety profile and clinical outcomes of the lasers and energy-based devices to treat the symptoms associated with vulvovaginal atrophy (VVA)
Detailed description
This is a prospective, investigational study that will be performed in private outpatient clinic on 30 participants.
All participants will be scheduled for four visits (V1, V2, V3, and V4) with a 4- week interval where they will receive the interventions in the first three visits (V1, V2, and V3), While in the last visit (V4), the study will assess the participants' satisfaction with the treatment and any adverse events they experienced during the study period.
Detailed medical history of all participants will be collected including age, age at menopause, parity, type of delivery, history of vaginal reconstructive surgery, history of hormonal treatment, and sexual activity status.
At each visit (V1, V2, V3, and V4), the participants will be interviewed to assess Vaginal Health Index using the VHI score and assess the changes in the Female Sexual Function Index FSFI.
Signs of vaginal atrophy will be evaluated during pelvic examination After pelvic examination and completion of the questionnaire, the interventions will be performed.
The participants will receive the interventions in the first three visits (V1, V2, and V3).While in the last visit (V4), the study will assess the participants' satisfaction with the treatment and any adverse events they experienced during the study period.
The Procedures will be performed in private outpatient clinic. The participants will receive the intervention by using the CO2 laser machine. Using the following settings with the internal handpiece: square pattern with Deep Mode, fractional density of 5% and energy level of 50 mJ and fluence of 283 J/cm2. The handpiece will be inserted into the vagina (up to 10 cm) The handpiece will be positioned with contact to the vagina and will be rotated to apply 12 pulses at each 1-cm marking (application of laser energy at 3-10-cm depths) until the distal end of the vaginal probe reaches the introitus.
The laser application will be performed on an outpatient basis without local anesthesia in outpatient clinic.
Participants will be advised to avoid sexual intercourse or intravaginal devices for at least 3 days after the procedure owing to transient local inflammation at the vaginal mucosa generated by the laser application.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention by using the Fractional CO2 laser | Experimental | Device: Fractional CO2 laser. Using the following settings with the internal handpiece: square pattern with Deep Mode, fractional density of 5% and energy level of 50 mJ and fluence of 283 J/cm2. The handpiece will be inserted into the vagina (up to 10 cm) The handpiece will be positioned with contact to the vagina and will be rotated to apply 12 pulses at each 1-cm marking (application of laser energy at 3-10-cm depths) until the distal end of the vaginal probe reaches the introitus. The laser application will be performed on an outpatient basis without local anesthesia in outpatient clinic. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Menopausal women whose ages ranged from 45 to 65 years.
- Sexually active
- Had symptoms of VVA (vaginal dryness, irritation, soreness, or dyspareunia)
Key exclusion criteria (8 listed)
- Any history of hormonal therapy within the past 6 months
- Vaginal moisturizer or lubricant applications within the past 30 days
- Acute/recurrent urinary tract infection
- Active genital infection
- Prolapse stage II or more based on examination
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 |
|---|---|---|
| Fractional CO2 laser. Using the following settings with the internal handpiece: square pattern with Deep Mode, fractional density of 5% and energy level of 50 mJ and fluence of 283 J/cm2. The handpiece will be inserted into the vagina (up to 10 cm) The handpiece will be positioned with contact to the vagina and will be rotated to apply 12 pulses at each 1-cm marking (application of laser energy at 3-10-cm depths) until the distal end of the vaginal probe reaches the introitus. The laser application will be performed on an outpatient basis without local anesthesia in outpatient clinic. | Device | intervention by using the Fractional CO2 laser |
Primary outcome
The Vulvovaginal Symptoms Questionnaire (VVSQ)
Time frame: 4-6 months
The Vaginal Health Index VHI assessment.
Time frame: 4-6 months
3 secondary outcomes
Urogenital Distress Short Form (UDI-6
Time frame: 4-6 months
Incontinence Impact Questionnaire Short Form (IIQ-7)
Time frame: 4-6 months
Female Sexual Function Index (FSFI)
Time frame: 4-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Post Menopausal Vaginal Atrophy
Not yet recruitingPhase 4
Difference in Serum Estrogen Level Based on Methods of Vaginal Estrogen Application (fingertip Vs Applicator Use) in Post-menopausal Women
Postmenopausal Atrophic Vaginitis, Genitourinary Syndrome of Menopause
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional CO2 laser in people with Post Menopausal Vaginal Atrophy, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 10 Dec 2024. 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 Egypt. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Onsi (+201272755335, daniel.onsi@ngu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Vulvovaginal Symptoms Questionnaire (VVSQ) (time frame: 4-6 months). The study lists 2 primary outcomes in all. 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 10 Dec 2024.