LasersNCT04297319
The Use of Laser in the Treatment of Atrophic Vulvovaginitis
A study testing Laser diiodo in people with Lasers and Atrophy of Vagina, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
This study evaluates the efficacy and security of laser for atrophy treatment. Half of participants will receive the laser treatment and the other half placebo. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Lasers, Atrophy of Vagina, Atrophy Vulva
- What is being tested?
- Laser diiodo
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteArgentina
- Study dates
- 20 Sep 2019to 1 Dec 2021
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Menopause women with vulvovaginal symptoms of atrophy
- No previous estrogen treatment for the last 30 days
- Active sexual life (vaginal penetration)
- Accept to participate
- Pap atrophy or hypotrophy in the last year
Who cannot join
- Vulvovaginal diseases
- Abnormal uterine bleeding
- Antidepressants drugs
- Uncontrolled diabetes
- Cervical intraepithelial lesions or cancer
- Photosensitized or under treatment with photosensibilized drugs
Show all 9Show fewer
- Collagen diseases
- Vulvovaginal infections in the last 15 days
- Immunosuppressed patients or under immunosuppressed treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Laser in the Treatment of Atrophic Vulvovaginitis and Its Consequent Improvement in Sexual Satisfaction
This study evaluates the efficacy and security of laser for atrophy treatment. Half of participants will receive the laser treatment and the other half placebo.
Read the detailed description
Thermal laser treatments are proposed as the newest treatments for atrophy. Through the thermal effect it would stimulates de mucosa, enhances the collagen component and the vascularization. Collagen remodeling and new collagen synthesis has been suggested as a mechanism of laser induced skin resurfacing and remodeling of vaginal connective tissue.
- Conditions
- Lasers, Atrophy of Vagina, Atrophy Vulva
- Being tested
- Laser diiodo, Laser Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser diiodoProcedure or surgery
3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks It is an outpatient procedure, not anesthesia required.
Laser PlaceboProcedure or surgery
3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks. It is an outpatient procedure, not anesthesia required.
| Study group | Role | What they receive |
|---|---|---|
| 1 - Laser intervention | Experimental | Laser diiodo treatment, 3 procedures of 5-10 minutes at intervals of 4 weeks Receives: Procedure: Laser diiodo |
| 2 - Laser placebo | Placebo comparator | Only the laser speculum is placed in the vagina but the laser is not activated. 3 procedures of 5-10 minutes at intervals of 4 weeks Receives: Procedure: Laser Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Female Sexual Function Index questionnaire
Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome
Measured: baseline, and week 4 after treatment
Change from Baseline in Female Sexual Function Index questionnaire
Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome
Measured: baseline,and week 12 after treatment
Change from Baseline in Female Sexual Function Index questionnaire
Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome
Measured: baseline, and week 36 after treatment
Vaginal Cytology Improvement
Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy
Measured: baseline, and week 4 after treatment
Vaginal Cytology Improvement
Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy
Measured: baseline, and week 12 after treatment
Vaginal Cytology Improvement
Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy
Measured: baseline, and week 36 after treatment
Change in vaginal acidity measure
the normal vaginal acidity is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)
Measured: baseline, and week 4 after treatment
Change in vaginal acidity measure
the normal vaginal acidity is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)
Measured: baseline, and week 12 after treatment
Change in vaginal pH measure
the normal vaginal ph is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)
Measured: baseline,and week 36 after treatment
Secondary outcomes (1)
Number of patient with Local Estrogen therapy requirement post intervention
Number of patients that Need estrogen replacement for atrophy vulvovaginal symptoms, despite the intervention.This will be evaluate with a Yes/No question.
Measured: baseline,and week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start20 Sep 2019
- Primary completion1 May 2021
- Study completion1 Dec 2021
Why it stopped: This protocol was cancelled due to the COVID pandemic restrictions in our country. It was imposible to complete the recruitment of patients to achive the study objectives.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LasersStudies 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
- Model description
- Double blind, randomized, control clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CLAUDIA ESTER MARCHITELLI, Hospital Italiano de Buenos Aires
- Investigators
- claudia E Marchitelli, MD, Principal investigator, Hospital Italiano de Buenos Aires, Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297319
- Sponsor's protocol ID
- 5076
- Status last verified
- Aug 2022
- First submitted
- 5 Nov 2019
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Knight C, Logan V, Fenlon D. A systematic review of laser therapy for vulvovaginal atrophy/genitourinary syndrome of menopause in breast cancer survivors. Ecancermedicalscience. 2019 Dec 12;13:988. doi: 10.3332/ecancer.2019.988. eCollection 2019.
PubMed 32010212Adabi K, Golshahi F, Niroomansh S, Razzaghi Z, Ghaemi M. Effect of the Fractional CO2 Laser on the Quality of Life, General Health, and Genitourinary Symptoms in Postmenopausal Women With Vaginal Atrophy: A Prospective Cohort. J Lasers Med Sci. 2020 Winter;11(1):65-69. doi: 10.15171/jlms.2020.11. Epub 2020 Jan 18.
PubMed 32099629
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Laser in the Treatment of Atrophic Vulvovaginitis and Its Consequent Improvement in Sexual Satisfaction
- ClinicalTrials.gov ID
- NCT04297319
- Acronym / sponsor ID
- 5076
- Conditions
- Lasers, Atrophy of Vagina, Atrophy Vulva
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This protocol was cancelled due to the COVID pandemic restrictions in our country. It was imposible to complete the recruitment of patients to achive the study objectives.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 5 Mar 2020 (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 study evaluates the efficacy and security of laser for atrophy treatment. Half of participants will receive the laser treatment and the other half placebo.
Detailed description
Thermal laser treatments are proposed as the newest treatments for atrophy. Through the thermal effect it would stimulates de mucosa, enhances the collagen component and the vascularization. Collagen remodeling and new collagen synthesis has been suggested as a mechanism of laser induced skin resurfacing and remodeling of vaginal connective tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, randomized, control clinical trial
| Arm | Type | Receives |
|---|---|---|
| 1 - Laser intervention | Experimental | Procedure: Laser diiodoLaser diiodo treatment, 3 procedures of 5-10 minutes at intervals of 4 weeks |
| 2 - Laser placebo | Placebo comparator | Procedure: Laser PlaceboOnly the laser speculum is placed in the vagina but the laser is not activated. 3 procedures of 5-10 minutes at intervals of 4 weeks |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Menopause women with vulvovaginal symptoms of atrophy
- No previous estrogen treatment for the last 30 days
- Active sexual life (vaginal penetration)
- Accept to participate
- Pap atrophy or hypotrophy in the last year
Key exclusion criteria (9 listed)
- Vulvovaginal diseases
- Abnormal uterine bleeding
- Antidepressants drugs
- Uncontrolled diabetes
- Cervical intraepithelial lesions or cancer
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 |
|---|---|---|
| Laser diiodo3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks It is an outpatient procedure, not anesthesia required. | Procedure or surgery | 1 - Laser intervention |
| Laser Placebo3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks. It is an outpatient procedure, not anesthesia required. | Procedure or surgery | 2 - Laser placebo |
Primary outcome
Change from Baseline in Female Sexual Function Index questionnaire
Time frame: baseline, and week 4 after treatment
Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome
Change from Baseline in Female Sexual Function Index questionnaire
Time frame: baseline,and week 12 after treatment
Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome
Change from Baseline in Female Sexual Function Index questionnaire
Time frame: baseline, and week 36 after treatment
Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome
Vaginal Cytology Improvement
Time frame: baseline, and week 4 after treatment
Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy
Vaginal Cytology Improvement
Time frame: baseline, and week 12 after treatment
Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy
Vaginal Cytology Improvement
Time frame: baseline, and week 36 after treatment
Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy
Change in vaginal acidity measure
Time frame: baseline, and week 4 after treatment
the normal vaginal acidity is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)
Change in vaginal acidity measure
Time frame: baseline, and week 12 after treatment
the normal vaginal acidity is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)
Change in vaginal pH measure
Time frame: baseline,and week 36 after treatment
the normal vaginal ph is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)
1 secondary outcome
Number of patient with Local Estrogen therapy requirement post intervention
Time frame: baseline,and week 48
Results and safety
The study was stopped early (reason given: This protocol was cancelled due to the COVID pandemic restrictions in our country. It was imposible to complete the recruitment of patients to achive the study objectives.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Background: PubMed 32010212Knight C, Logan V, Fenlon D. A systematic review of laser therapy for vulvovaginal atrophy/genitourinary syndrome of menopause in breast cancer survivors. Ecancermedicalscience. 2019 Dec 12;13:988. doi: 10.3332/ecancer.2019.988. eCollection 2019.
- Results publication: PubMed 32099629Adabi K, Golshahi F, Niroomansh S, Razzaghi Z, Ghaemi M. Effect of the Fractional CO2 Laser on the Quality of Life, General Health, and Genitourinary Symptoms in Postmenopausal Women With Vaginal Atrophy: A Prospective Cohort. J Lasers Med Sci. 2020 Winter;11(1):65-69. doi: 10.15171/jlms.2020.11. Epub 2020 Jan 18.
- 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.
claudia E Marchitelli, MD principal investigator
Hospital Italiano de Buenos Aires, Argentina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser diiodo in people with Lasers and Atrophy of Vagina, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 5 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: stopped early, as of the sponsor's last update on 9 Aug 2022. 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 Argentina. 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 was stopped early (reason given: This protocol was cancelled due to the COVID pandemic restrictions in our country. It was imposible to complete the recruitment of patients to achive the study objectives.). Results are not available in the source record.
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?
Change from Baseline in Female Sexual Function Index questionnaire (time frame: baseline, and week 4 after treatment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04297319, which also lists 2 linked publications.
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 9 Aug 2022.