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
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
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- 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