Vaginal AtrophyNCT04717245
Comparative Study: Vaginal Promestriene Use, Fractional CO2 LASER and Radiofrequency in the Vaginal Atrophy Treatment
A study testing Promestriene Vaginal, Fractional CO2 LASER and Microablative Fractional radiofrequency in people with Vaginal Atrophy, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Postmenopausal hypoestrogenism may determine genital atrophy, which may be accompanied by a non-specific inflammatory process and may hinder or even prevent sexual intercourse. In more severe cases, the patient may have local pain that interferes with their daily activities. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Vaginal Atrophy
- What is being tested?
- Promestriene Vaginal, Fractional CO2 LASER and Microablative Fractional radiofrequency
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Oct 2018to 18 Feb 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal or superior to 40 years and under 65 years
- Clinical menopause - last menstrual period from 1 to 5 years from the date of recruitment
- FSH measurement> 25 IU / ml, estrogen <20 æg / ml
- Patients with vaginal atrophy and clinical and / or sexual symptoms
- Patients without hormonal treatment for at least five years
Who cannot join
- Whole Hymen
- Altered oncology cytology of the cervix and / or vagina
- Vaginal infections
- Connective tissue diseases
- Immunosuppression
- Coagulation change
Show all 10Show fewer
- Diabetes Mellitus
- Thyroid diseases
- Use of systemic or local feminine hormones
- Use of other substances with estrogenic properties
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Disciplina de ginecologia - departamento de ginecologia e obstetrícia - faculdade de medicina da USP
São Paulo, 01246-100
About this study
Official title: Comparative Study : The Effect of Vaginal Estrogen Use, Fractional CO2 LASER and Microablative Fractional Radiofrequency in the Treatment of Vaginal Atrophy: Clinical, Histological, Immunohistochemical and Molecular Biology Study
Postmenopausal hypoestrogenism may determine genital atrophy, which may be accompanied by a non-specific inflammatory process and may hinder or even prevent sexual intercourse. In more severe cases, the patient may have local pain that interferes with their daily activities. The best treatment for increasing genital trophism is still estrogen. However, there are women who can not use this therapy or do not want it. Therefore, there is a need for alternatives, such as ablation techniques: use of CO2 LASER and fractional radiofrequency.
The study was carried out at the outpatient clinic of Lower Genital Tract ambulatory of the Discipline of Gynecology, Department of Obstetrics and Gynecology, Clinical Hospital, Faculty of Medicine, University of São Paulo, involving 75 women who were divided after randomization in three groups:
Read more
Group 1 - treatment with topical vaginal promestriene (n = 25 patients); Group 2 - treatment with fractional CO2 LASER (n = 25 patients); Group 3 - fractional microablative radiofrequency treatment (n = 25 patients).
An evaluation of the complaints were be performed through questionnaires on sexuality, quality of life and urinary incontinence, as well as biopsies of the vaginal wall for histomorphometric, immunohistochemical and molecular biology study before and after six months of treatment. The duration of the study were fifteen months.
Read the detailed description
After completing the eligibility criteria, patients signed the consent inform.
Division of groups:
Were included in the study 75 patients, divided into three groups:
Group 1 - Treatment with topical vaginal promestriene - 25 patients in this group were included patients free of systemic or topical hormonal treatment for at 3 months
Group 2 - Treatment with CO2 LASER - 25 patients, in this group were included patients free of systemic or topical hormonal treatment for at 3 months.
Group 3 - Treatment with microablative fractionated radiofrequency - 25 patients in this group were included patients free of systemic or topical hormonal treatment for at least 3 months.
The present study was open and randomized. The randomization was be performed through the software "Test Generator Software Standard Edition"
At the first visit, all patients responded to the clinical questionnaire of female sex quotient (QS-F), the quality of life questionnaire (SF-36) and the urinary incontinence questionnaire.
All patients were submitted to specular gynecological examination to collect cervical-vaginal cytology, biopsy of 1/3 proximal vaginal wall for histological analysis and immunohistochemistry.
After the results of the examinations and possible treatments required, the patients were referred for the proposed treatments according to their randomized group.
Sampling Cytology :Cervical and vaginal oncology cytology were collected through a smear on a slide with fixative.
The histological expression of the following immunohistochemical parameters will be evaluated:
- Presence and density of estrogen receptors
- Vascular density
- Thickness of the epithelium
- Density of collagen fibers
- Vaginal microbiota
- Vaginal pH
In this study, it will be done a Morphological Analysis, a Histomorphometric analysis and e Immunohistochemical analysis.
- Conditions
- Vaginal Atrophy
- Being tested
- Promestriene Vaginal, Fractional CO2 LASER, Microablative Fractional radiofrequency
- Keywords
- genital atrophy, fractional CO2 laser, microablative fractional radiofrequency, quality of life, sexuality, promestriene, Menopause genitourinary syndrome
- Medical subject headings
- Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promestriene VaginalDrug
Also called Promestrieno
Patients used promestriene vaginal cream for 3 months. The use was recommended to be diary fot the first 2 weeks, and then, repeat every 3 days.
Fractional CO2 LASEROther
LASER treatment with fractional CO2 Laser was performed in 3 sessions with intervals of 4 weeks between them. Before each session, the patients underwent specular examination.
Fractional CO2 LASER was applied following these parameters, fixed in all sessions: vagina wall - power40 W, dwel time 1000 mcs, spacing 1000 mcm and stack 2, vestibule - power 10W, dwel time 500mcs, spacing 300mcg and satck 1
Microablative Fractional radiofrequencyOther
Microablative fractional radiofrequency was performed with the equipment calibrated in FRAXX mode, 45W, Low Energy program 40 milliseconds in the vaginal and introitus wall. Lidocaine spray was applied to vaginal introitus before the procedure.
The patient was in the gynecological position. The vaginal speculum was placed and, afterwards, the vaginal antisepsis was performed with aqueous chlorhexidine and cleaning with 0.9% saline solution.
All liquid contents were wiped off before beginning the procedure. The fractured tip will be pressed lightly and as perpendicular as possible into the vulvar or vaginal surface, ensuring full contact of all points in the tissue, starting at the lateral vaginal walls and from the proximal to the distal third.
| Study group | Role | What they receive |
|---|---|---|
| Fractional CO2 LASER | Active comparator | Vaginal fractional CO2 LASER 3 sessions applications Receives: Other: Fractional CO2 LASER |
| Microablative fractional radiofrequency | Active comparator | Vaginal Microablative fractional radiofrequency 3 sessions application Receives: Other: Microablative Fractional radiofrequency |
| Promestriene Vaginal | Active comparator | Promestriene vaginal use during 3 months Receives: Drug: Promestriene Vaginal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life's quality questionnaire
It was acessed at the beginnig and in the end of the treatment. We used the Short Form Health Survey 36 questionnaire for this parameter. It contains 36 items measuring eight dimensions, that vary the pontuation between 1-5 to 1-6. All but one of the 36 items are used to score the SF-36 eight domains that are aggregated in two summary measures, Physical and Mental components. Among the eight domains, three scales (Physical Functioning, Role-Physical, and Bodily Pain) contributes mostly to the Physical Component Summary (PCS) and three (Mental Health, Role-Emotional, and Social Functioning) contributes to the Mental Component Summary. The domains Vitality, General Health, and Social Functioning present noteworthy correlations with both summary componentNormalized scores below 50 are interpreted as below the generals population. The better is to have a higher pontuation.
Measured: 3-4 months
Secondary outcomes (3)
Sexuality questionnaire - Female Sexual Function Index
This questionnaire analyses 6 parameters: desire, excitation, lubrication, orgasm, satisfaction and pain. Tha maximum pontuation for each parameter is 6, and for the entire questionnaire is 36 (the best pontuation).
Measured: 3-4 months
pH values
We used a pH tape to determine the vaginal pH. The normal measure é between 3,8 and 4,5.
Measured: 3-4 months
score symptoms
Patients describe these symptoms dryness, itching, burnig and pain as absent (0 points); mild :1 point; moderate : 2 points and severe : 3 points, at the begging and in the end of the treatment. The best pontuation is zero and the worst is 12.
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start25 Oct 2018
- Primary completion7 Mar 2019
- Study completion18 Feb 2020
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 Vaginal AtrophyStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, 75 patients were included, divided into these three groups: Group 1 - Treatment with topical vaginal promestriene - 25 patients were included in this group Group 2 - Treatment with fractional CO2 LASER - 25 patients were included in this group Group 3 - Treatment with microablative fractional radiofrequency - 25 patients were included in this group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Maria Soares Junior, PHD, Study director, Universidade de São Paulo departamento de ginecologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717245
- Sponsor's protocol ID
- CAI
- Status last verified
- Aug 2018
- First submitted
- 28 Aug 2018
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seganfredo IB, Bianchi C, Tacla M, Chedraui P, Haddad JM, Simoes R, Baracat EC, Soares JM Jr. Comparison of promestriene with vaginal fractional CO2 laser and radiofrequency treatments of genitourinary syndrome of menopause. Maturitas. 2024 Aug;186:108008. doi: 10.1016/j.maturitas.2024.108008. Epub 2024 Apr 24.
PubMed 38714422
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study : The Effect of Vaginal Estrogen Use, Fractional CO2 LASER and Microablative Fractional Radiofrequency in the Treatment of Vaginal Atrophy: Clinical, Histological, Immunohistochemical and Molecular Biology Study
- ClinicalTrials.gov ID
- NCT04717245
- Acronym / sponsor ID
- CAI
- Conditions
- Vaginal Atrophy
- Keywords
- genital atrophy, fractional CO2 laser, microablative fractional radiofrequency, quality of life, sexuality, promestriene, Menopause genitourinary syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 22 Jan 2021 (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.
Postmenopausal hypoestrogenism may determine genital atrophy, which may be accompanied by a non-specific inflammatory process and may hinder or even prevent sexual intercourse. In more severe cases, the patient may have local pain that interferes with their daily activities. The best treatment for increasing genital trophism is still estrogen. However, there are women who can not use this therapy or do not want it. Therefore, there is a need for alternatives, such as ablation techniques: use of CO2 LASER and fractional radiofrequency.
The study was carried out at the outpatient clinic of Lower Genital Tract ambulatory of the Discipline of Gynecology, Department of Obstetrics and Gynecology, Clinical Hospital, Faculty of Medicine, University of São Paulo, involving 75 women who were divided after randomization in three groups:
Group 1 - treatment with topical vaginal promestriene (n = 25 patients); Group 2 - treatment with fractional CO2 LASER (n = 25 patients); Group 3 - fractional microablative radiofrequency treatment (n = 25 patients).
An evaluation of the complaints were be performed through questionnaires on sexuality, quality of life and urinary incontinence, as well as biopsies of the vaginal wall for histomorphometric, immunohistochemical and molecular biology study before and after six months of treatment. The duration of the study were fifteen months.
Detailed description
After completing the eligibility criteria, patients signed the consent inform.
Division of groups:
Were included in the study 75 patients, divided into three groups:
Group 1 - Treatment with topical vaginal promestriene - 25 patients in this group were included patients free of systemic or topical hormonal treatment for at 3 months
Group 2 - Treatment with CO2 LASER - 25 patients, in this group were included patients free of systemic or topical hormonal treatment for at 3 months.
Group 3 - Treatment with microablative fractionated radiofrequency - 25 patients in this group were included patients free of systemic or topical hormonal treatment for at least 3 months.
The present study was open and randomized. The randomization was be performed through the software "Test Generator Software Standard Edition"
At the first visit, all patients responded to the clinical questionnaire of female sex quotient (QS-F), the quality of life questionnaire (SF-36) and the urinary incontinence questionnaire.
All patients were submitted to specular gynecological examination to collect cervical-vaginal cytology, biopsy of 1/3 proximal vaginal wall for histological analysis and immunohistochemistry.
After the results of the examinations and possible treatments required, the patients were referred for the proposed treatments according to their randomized group.
Sampling Cytology :Cervical and vaginal oncology cytology were collected through a smear on a slide with fixative.
The histological expression of the following immunohistochemical parameters will be evaluated:
- Presence and density of estrogen receptors
- Vascular density
- Thickness of the epithelium
- Density of collagen fibers
- Vaginal microbiota
- Vaginal pH
In this study, it will be done a Morphological Analysis, a Histomorphometric analysis and e Immunohistochemical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- In this study, 75 patients were included, divided into these three groups: Group 1 - Treatment with topical vaginal promestriene - 25 patients were included in this group Group 2 - Treatment with fractional CO2 LASER - 25 patients were included in this group Group 3 - Treatment with microablative fractional radiofrequency - 25 patients were included in this group
| Arm | Type | Receives |
|---|---|---|
| Fractional CO2 LASER | Active comparator | Other: Fractional CO2 LASERVaginal fractional CO2 LASER 3 sessions applications |
| Microablative fractional radiofrequency | Active comparator | Other: Microablative Fractional radiofrequencyVaginal Microablative fractional radiofrequency 3 sessions application |
| Promestriene Vaginal | Active comparator | Drug: Promestriene VaginalPromestriene vaginal use during 3 months |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age equal or superior to 40 years and under 65 years
- Clinical menopause - last menstrual period from 1 to 5 years from the date of recruitment
- FSH measurement> 25 IU / ml, estrogen <20 æg / ml
- Patients with vaginal atrophy and clinical and / or sexual symptoms
- Patients without hormonal treatment for at least five years
Key exclusion criteria (10 listed)
- Whole Hymen
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 |
|---|---|---|
| Promestriene VaginalAlso: PromestrienoPatients used promestriene vaginal cream for 3 months. The use was recommended to be diary fot the first 2 weeks, and then, repeat every 3 days. | Drug | Promestriene Vaginal |
| Fractional CO2 LASERLASER treatment with fractional CO2 Laser was performed in 3 sessions with intervals of 4 weeks between them. Before each session, the patients underwent specular examination. Fractional CO2 LASER was applied following these parameters, fixed in all sessions: vagina wall - power40 W, dwel time 1000 mcs, spacing 1000 mcm and stack 2, vestibule - power 10W, dwel time 500mcs, spacing 300mcg and satck 1 | Other | Fractional CO2 LASER |
| Microablative Fractional radiofrequencyMicroablative fractional radiofrequency was performed with the equipment calibrated in FRAXX mode, 45W, Low Energy program 40 milliseconds in the vaginal and introitus wall. Lidocaine spray was applied to vaginal introitus before the procedure. The patient was in the gynecological position. The vaginal speculum was placed and, afterwards, the vaginal antisepsis was performed with aqueous chlorhexidine and cleaning with 0.9% saline solution. All liquid contents were wiped off before beginning the procedure. The fractured tip will be pressed lightly and as perpendicular as possible into the vulvar or vaginal surface, ensuring full contact of all points in the tissue, starting at the lateral vaginal walls and from the proximal to the distal third. | Other | Microablative fractional radiofrequency |
Primary outcome
Life's quality questionnaire
Time frame: 3-4 months
It was acessed at the beginnig and in the end of the treatment. We used the Short Form Health Survey 36 questionnaire for this parameter. It contains 36 items measuring eight dimensions, that vary the pontuation between 1-5 to 1-6. All but one of the 36 items are used to score the SF-36 eight domains that are aggregated in two summary measures, Physical and Mental components. Among the eight domains, three scales (Physical Functioning, Role-Physical, and Bodily Pain) contributes mostly to the Physical Component Summary (PCS) and three (Mental Health, Role-Emotional, and Social Functioning) contributes to the Mental Component Summary. The domains Vitality, General Health, and Social Functioning present noteworthy correlations with both summary componentNormalized scores below 50 are interpreted as below the generals population. The better is to have a higher pontuation.
3 secondary outcomes
Sexuality questionnaire - Female Sexual Function Index
Time frame: 3-4 months
pH values
Time frame: 3-4 months
score symptoms
Time frame: 3-4 months
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 25 Jan 2021.
- Derived from this study: PubMed 38714422Seganfredo IB, Bianchi C, Tacla M, Chedraui P, Haddad JM, Simoes R, Baracat EC, Soares JM Jr. Comparison of promestriene with vaginal fractional CO2 laser and radiofrequency treatments of genitourinary syndrome of menopause. Maturitas. 2024 Aug;186:108008. doi: 10.1016/j.maturitas.2024.108008. Epub 2024 Apr 24.
- 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.
Jose Maria Soares Junior, PHD study director
Universidade de São Paulo departamento de ginecologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promestriene Vaginal, Fractional CO2 LASER and Microablative Fractional radiofrequency in people with Vaginal Atrophy, run by University of Sao Paulo General Hospital 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 5 inclusion and 10 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 25 Jan 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 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?
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?
Life's quality questionnaire (time frame: 3-4 months). 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 NCT04717245, 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 25 Jan 2021.