Postmenopausal Atrophic VaginitisEPMLARF-arm1NCT04045379
LASER and Radiofrequency and Genitourinary Syndrome of Menopause
A study testing LASER, Microablative Radiofrequency and Estriol in people with Postmenopausal Atrophic Vaginitis and Postmenopausal Symptoms, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
This is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic strogen to treat symptoms of vulvovaginal atrophy of post menopause. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Postmenopausal Atrophic Vaginitis, Postmenopausal Symptoms, Genitourinary Symptoms
- What is being tested?
- LASER, Microablative Radiofrequency and Estriol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Aug 2019to Aug 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between 2 and 5 years after menopause, without hormone therapy for at least 2 years
- To present, at least moderate, or severe intensity (score 4 or more of visual analog scale ( 0-10)) of one of the signs or symptoms of of vulvovaginal atrophy:
- Burning
- Discomfort
- Dryness
- Cracks
Show all 14Show fewer
- Pruritus
- Lack of vaginal lubrication
- Penetration dyspareunia that began at the menopausal or postmenopausal transition
- Decreased vaginal epithelium turgor and trophism
- Deletion of mucous and skin folds.
- The Exclusion criteria will be:
- Active genital infection, active infection of HPV (human papillomavirus) or Herpes, users of medications with estrogenic effect (digoxin, tamoxifen and other chemicals)
- Postmenopausal genital bleeding, uncontrolled diabetes, use of multivitamins with zinc, use of copper or hormonal IUDs (intrauterine device) at the time of inclusion, presence of genitourinary or rectovaginal fistulas.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Sao Paulo - Unifesp
São Paulo, São Paulo, 0-4023- 062
About this study
Official title: LASER and Radiofrequency as Alternative Treatments for Genitourinary Syndrome of Menopause
This is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic strogen to treat symptoms of vulvovaginal atrophy of post menopause.
Read the detailed description
Post menopause women with moderate or severe signs or symptoms of vulvovaginal atrophy will be eligible for the study.
The patients will be randomized to receive one of the three intravaginal therapies: LASER, Micro Ablative radiofrequency or Estriol. The applications will occur in the interval of 30 days for 3 times, for LASER and Radiofrequency groups. For the estriol group, the application will be done by the patient, daily for 2 weeks and them twice a week for 3 months, and each 30 days, the patients will have an appointment when will be checked the weight of the estriol tube, to verify the correct use.
The follow-up visits will occur 30, 90, 180 and 360 days after the conclusion of the third month of treatment.
Will be evaluated: vulvar and vaginal histology before and after the use of LASER, radiofrequency or estriol; microbiota and vaginal pH before and after the use of LASER, radiofrequency or estriol; extracellular matrix and metalloproteinases in the remodeling of vulvovaginal collagen induced by estrogen, LASER and radiofrequency; quality of life, sexual dysfunctions and complaints before and after the use of LASER, radiofrequency or hormones; metabolomics and vaginal microbiome.
- Being tested
- LASER, Microablative Radiofrequency, Estriol
- Keywords
- postmenopause, atrophic vaginitis, vulvovaginal atrophy, treatment, LASER, Radiofrequency, estriol, strogen therapy
- Medical subject headings
- Atrophic Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASERProcedure or surgery
Also called Fractional Co2 (carbon dioxide)Laser, MonaLisa Touch® treatment, SmartXide Touch V²LR® Deka
Use of the SmartXide Touch V²LR, Co2 Laser System to perform ambulatory intravaginal and vulvar application of LASER, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the LASER will be applied, according to the protocol of the manufactured.
Microablative RadiofrequencyProcedure or surgery
Also called FRAAX, Linly™ Loktal Medical Electronics
Use of Linly™ equipment to perform ambulatory intravaginal and vulvar application of fractionated microablative radiofrequency, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the radiofrequency will be applied, according to the protocol of the manufactured.
EstriolDrug
Also called Estriol 01mg/ml
The patient will perform self application of this vaginal estriol daily for 2 weeks and after that the applications will occur twice a week.
| Study group | Role | What they receive |
|---|---|---|
| LASER | Active comparator | The patients will receive 3 consecutive applications of intravaginal and vulvar CO2 (carbon dioxide)LASER, according to the manufacturer protocol for vaginal atrophy. The applications will be separated by the interval of 30 days Receives: Procedure: LASER |
| Micro Ablative Radiofrequency | Active comparator | The patients will receive 3 consecutive applications of intravaginal and vulvar MIcro ablative radiofrequency, according to the manufacturer protocol for vaginal atrophy. The applications will be separated by the interval of 30 days Receives: Procedure: Microablative Radiofrequency |
| Estriol | Active comparator | The patient will use intravaginal estriol, daily for 2 weeks and them twice a week for 3 months . Each 30 days, the patients will have an appointment when will be checked the weight of the estriol tube to verify the correct use. Receives: Drug: Estriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Improvement of signs and symptoms postmenopausal genitourinary syndrome with intravaginal LASER, Microablative Radiofrequency, and topic estriol
Will be applied a Visual Analogic Scale (0-10) to access the improvement of genitourinary signs and symptoms, the results of the three groups will be compared
Measured: The evaluation will be done 180 days after treatment
Satisfaction of postmenopausal women with genitourinary syndrome with the treatment by intravaginal LASER, Micro ablative Radiofrequency, and topic estriol
Will be applied a LIKERT Satisfaction Scale (1-5) to access the satisfaction with the treatment, the results of the three groups will be compared
Measured: The evaluation will be done 180 days after treatment
Secondary outcomes (8)
Evaluation of Microbiota before and after the use of intravaginal LASER, Micro Ablative radiofrequency or topic estriol.
The vaginal flora will be evaluated by vaginal smear. The results of the three groups will be compared
Measured: The evaluation will occur pre treatment 30, 90 , 180 and 360 days after treatment
Evaluation of vaginal pH before and after the use of intravaginal LASER, Micro ablative radiofrequency or topic estriol.
The vaginal pH will be verified by the use of pH tape's .The results of the three groups will be compared
Measured: The evaluation will occur pre treatment and 30, 90, 180 and 360 days after treatment
Histologic evaluation of vagina and vulva before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
Thickness of epithelium (mm and number of layers), and evaluation of expression of Ki-67 and VEGF (vascular endothelial growth factor) will be done on vaginal and vulvar biopsies.The results of the three groups will be compared
Measured: The evaluation will occur pre treatment and 30 days after treatment
Evaluation of impact in Quality of life after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
The IQol (incontinence quality of life questionnaire, validated to portuguese language - score 0-100) will be used to evaluate quality of life .The results of the three groups will be compared
Measured: The evaluation will occur pre treatment and 30 days after treatment
Evaluation of impact in Sexual function after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
The FSF-I(Female Sexual Function Index , validated to portuguese language- score range from 2 - 36) will be used to evaluate sexual function . The results of the three groups will be compared
Measured: The evaluation will occur pre treatment and 30 days after treatment
Evaluation of extracellular matrix before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
Evaluation of the composition and concentration of the glycosaminoglycans of extracellular matrix in the vaginal and vulvar biopsies by specific markers. The results of the three groups will be compared
Measured: The evaluation will occur pre treatment and 30 days after treatment
Evaluation of matrix metalloproteinases(MMP) in remodeling of vulvovaginal collagen induced by intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
Evaluation of the tissue distribution of the MMP-1, MMP-2, MMP-3, MMP-7, MMP-9 metalloproteinases of collagen I, II, IV and elastin proteins by specific markers on vaginal and vulvar biopsies. The results of the three groups will be compared
Measured: The evaluation will occur pre treatment and 30 days after treatment
Evaluation of visual aspect of vulva after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
Pictures of vulva will be taken before and after treatment. The images will be evaluated by a blind gynecologist and dermatologist regarding the type of treatment and the chronological order of the photos, which will classify the images as: better; equal or worse, in relation to tropism and number of vulvar skin grooves, The results of the three groups will be compared
Measured: The pictures will be taken before and 30 days and 180 days after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start5 Aug 2019
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal Atrophic VaginitisStudies 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
- The patient will be randomized in block to receive one of the three intravaginal therapies: LASER, Radiofrequency and topic estriol
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Ana Maria Homem de Mello Bianchi, Federal University of São Paulo
- Investigators
- Zsuzsanna IK Jarmy - di Bella, PhD, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045379
- Sponsor's protocol ID
- CEP0431/2018 arm 1
- Acronym
- EPMLARF-arm1
- Status last verified
- Apr 2025
- First submitted
- 20 May 2019
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Oliveira CD, de Mello Bianchi AMH, Campos MLP, Nogueira MCC, Sartori MGF, de Gois Speck NM. Women with Genitourinary Syndrome of Menopause Treated with Vaginal Estriol, Microablative Fractional CO2 Laser and Microablative Fractional Radiofrequency: A Randomized Pilot Study. Photobiomodul Photomed Laser Surg. 2023 Dec;41(12):718-724. doi: 10.1089/photob.2023.0113.
PubMed 38085184
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LASER and Radiofrequency as Alternative Treatments for Genitourinary Syndrome of Menopause
- ClinicalTrials.gov ID
- NCT04045379
- Acronym / sponsor ID
- EPMLARF-arm1 / CEP0431/2018 arm 1
- Keywords
- postmenopause, atrophic vaginitis, vulvovaginal atrophy, treatment, LASER, Radiofrequency, estriol, strogen therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 5 Aug 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 is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic strogen to treat symptoms of vulvovaginal atrophy of post menopause.
Detailed description
Post menopause women with moderate or severe signs or symptoms of vulvovaginal atrophy will be eligible for the study.
The patients will be randomized to receive one of the three intravaginal therapies: LASER, Micro Ablative radiofrequency or Estriol. The applications will occur in the interval of 30 days for 3 times, for LASER and Radiofrequency groups. For the estriol group, the application will be done by the patient, daily for 2 weeks and them twice a week for 3 months, and each 30 days, the patients will have an appointment when will be checked the weight of the estriol tube, to verify the correct use.
The follow-up visits will occur 30, 90, 180 and 360 days after the conclusion of the third month of treatment.
Will be evaluated: vulvar and vaginal histology before and after the use of LASER, radiofrequency or estriol; microbiota and vaginal pH before and after the use of LASER, radiofrequency or estriol; extracellular matrix and metalloproteinases in the remodeling of vulvovaginal collagen induced by estrogen, LASER and radiofrequency; quality of life, sexual dysfunctions and complaints before and after the use of LASER, radiofrequency or hormones; metabolomics and vaginal microbiome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The patient will be randomized in block to receive one of the three intravaginal therapies: LASER, Radiofrequency and topic estriol
| Arm | Type | Receives |
|---|---|---|
| LASER | Active comparator | Procedure: LASERThe patients will receive 3 consecutive applications of intravaginal and vulvar CO2 (carbon dioxide)LASER, according to the manufacturer protocol for vaginal atrophy. The applications will be separated by the interval of 30 days |
| Micro Ablative Radiofrequency | Active comparator | Procedure: Microablative RadiofrequencyThe patients will receive 3 consecutive applications of intravaginal and vulvar MIcro ablative radiofrequency, according to the manufacturer protocol for vaginal atrophy. The applications will be separated by the interval of 30 days |
| Estriol | Active comparator | Drug: EstriolThe patient will use intravaginal estriol, daily for 2 weeks and them twice a week for 3 months . Each 30 days, the patients will have an appointment when will be checked the weight of the estriol tube to verify the correct use. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Women between 2 and 5 years after menopause, without hormone therapy for at least 2 years
- To present, at least moderate, or severe intensity (score 4 or more of visual analog scale ( 0-10)) of one of the signs or symptoms of of vulvovaginal atrophy:
- Active genital infection, active infection of HPV (human papillomavirus) or Herpes, users of medications with estrogenic effect (digoxin, tamoxifen and other chemicals)
- Postmenopausal genital bleeding, uncontrolled diabetes, use of multivitamins with zinc, use of copper or hormonal IUDs (intrauterine device) at the time of inclusion, presence of genitourinary or rectovaginal fistulas.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| LASERAlso: Fractional Co2 (carbon dioxide)Laser, MonaLisa Touch® treatment, SmartXide Touch V²LR® DekaUse of the SmartXide Touch V²LR, Co2 Laser System to perform ambulatory intravaginal and vulvar application of LASER, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the LASER will be applied, according to the protocol of the manufactured. | Procedure or surgery | LASER |
| Microablative RadiofrequencyAlso: FRAAX, Linly™ Loktal Medical ElectronicsUse of Linly™ equipment to perform ambulatory intravaginal and vulvar application of fractionated microablative radiofrequency, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the radiofrequency will be applied, according to the protocol of the manufactured. | Procedure or surgery | Micro Ablative Radiofrequency |
| EstriolAlso: Estriol 01mg/mlThe patient will perform self application of this vaginal estriol daily for 2 weeks and after that the applications will occur twice a week. | Drug | Estriol |
Primary outcome
Clinical Improvement of signs and symptoms postmenopausal genitourinary syndrome with intravaginal LASER, Microablative Radiofrequency, and topic estriol
Time frame: The evaluation will be done 180 days after treatment
Will be applied a Visual Analogic Scale (0-10) to access the improvement of genitourinary signs and symptoms, the results of the three groups will be compared
Satisfaction of postmenopausal women with genitourinary syndrome with the treatment by intravaginal LASER, Micro ablative Radiofrequency, and topic estriol
Time frame: The evaluation will be done 180 days after treatment
Will be applied a LIKERT Satisfaction Scale (1-5) to access the satisfaction with the treatment, the results of the three groups will be compared
8 secondary outcomes
Evaluation of Microbiota before and after the use of intravaginal LASER, Micro Ablative radiofrequency or topic estriol.
Time frame: The evaluation will occur pre treatment 30, 90 , 180 and 360 days after treatment
Evaluation of vaginal pH before and after the use of intravaginal LASER, Micro ablative radiofrequency or topic estriol.
Time frame: The evaluation will occur pre treatment and 30, 90, 180 and 360 days after treatment
Histologic evaluation of vagina and vulva before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
Time frame: The evaluation will occur pre treatment and 30 days after treatment
Evaluation of impact in Quality of life after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
Time frame: The evaluation will occur pre treatment and 30 days after treatment
Evaluation of impact in Sexual function after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
Time frame: The evaluation will occur pre treatment and 30 days after treatment
Evaluation of extracellular matrix before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
Time frame: The evaluation will occur pre treatment and 30 days after treatment
Evaluation of matrix metalloproteinases(MMP) in remodeling of vulvovaginal collagen induced by intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
Time frame: The evaluation will occur pre treatment and 30 days after treatment
Evaluation of visual aspect of vulva after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
Time frame: The pictures will be taken before and 30 days and 180 days after treatment.
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 22 Apr 2025.
- Derived from this study: PubMed 38085184de Oliveira CD, de Mello Bianchi AMH, Campos MLP, Nogueira MCC, Sartori MGF, de Gois Speck NM. Women with Genitourinary Syndrome of Menopause Treated with Vaginal Estriol, Microablative Fractional CO2 Laser and Microablative Fractional Radiofrequency: A Randomized Pilot Study. Photobiomodul Photomed Laser Surg. 2023 Dec;41(12):718-724. doi: 10.1089/photob.2023.0113.
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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.
Zsuzsanna IK Jarmy - di Bella, PhD study chair
Professor
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, Microablative Radiofrequency and Estriol in people with Postmenopausal Atrophic Vaginitis and Postmenopausal Symptoms, run by Federal University of São Paulo at 1 site in Brazil.
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 14 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2025. 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 Brazil. 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?
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?
Clinical Improvement of signs and symptoms postmenopausal genitourinary syndrome with intravaginal LASER, Microablative Radiofrequency, and topic estriol (time frame: The evaluation will be done 180 days after treatment). 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?
On the ClinicalTrials.gov record for NCT04045379, which also lists 1 linked publication.
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 22 Apr 2025.