Atrophy;VaginalNCT04902794
Light Emitting Diode in the Treatment of Genitourinary Syndrome of Menopause
A study testing Light Emitting Diode in people with Atrophy;Vaginal, run by Patricia Lordelo at 1 site in Brazil.
Trial summary
Introduction: The genitourinary menopause syndrome (MMS) affects 50% of postmenopausal women and, due to a decrease in hormone levels, triggers functional changes in the vagina and vagina, and impairment of quality of life and sexual function. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Atrophy;Vaginal
- What is being tested?
- Light Emitting Diode
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2021to 1 Dec 2023
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- menopausal women up to 65 years of age
- presence of clinical signs and symptoms of Menopause Genitourinary Syndrome :dryness and irritation of the vagina, pruritus, pain or discomfort in sexual intercourse, bleeding after sexual intercourse
- voluntarily participate in the research.
Who cannot join
- patients undergoing hormone replacement for less than 6 months
- diagnosis of vaginal infection
- difficulty in understanding the proposed instruments
- patients with chronic neurological degenerative diseases.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto Patrícia Lordelo
Salvador, Estado de Bahia, 41825-000
Patrícia Lordelo, +55(71)9 9659-2400, topfisio.topfisio@hotmail.com
About this study
Official title: Light Emitting Diode in the Treatment of Genitourinary Syndrome of Menopause: Randomized Controlled Clinical Trial
Introduction: The genitourinary menopause syndrome (MMS) affects 50% of postmenopausal women and, due to a decrease in hormone levels, triggers functional changes in the vagina and vagina, and impairment of quality of life and sexual function. Objective: To test the hypothesis that the 405 nm light emitting diode in the treatment of vulvovaginal atrophy is safe and effective, by reducing the symptomatology of the disease and histological alteration of the tissue. Methods: This is a pilot study in 10 volunteers with SGM, followed by a randomized, blinded trial in a sample of 58 individuals that will be performed at the Pelvic Floor Care Center (CAAP). Menopausal women up to 65 years of age and with clinical signs and symptoms of vulvovaginal atrophy syndrome (vaginal dryness and irritation, pruritus, pain or discomfort in intercourse, bleeding after sexual intercourse) and who voluntarily participate in the study will be included. Will be excluded from the study the patients in hormonal replacement for less than 6 months, diagnosis of vaginal infection, use of pacemaker, pregnant women, those who have performed Oophorectomy or presented ovarian cancer, difficulty understanding the proposed instruments and patients with chronic neurological degenerative diseases. Three 405 nm light emitting diode (LED) sessions will be performed, with a seven days interval between them. In the clinical trial, the study group will perform kinesiotherapy and LED.
The control group will perform kinesiotherapy and the LED will be turned off. Data collection will be performed initially and after the sessions through self-administered questionnaires containing socio-demographic and clinical information, Medical Outcomes Study 36, Short-Form Health Survey (SF-36), Female Sexual Function Index (FSFI) - Female Version (QS-F), Female Genital Self-Image Scale - 7 (FGSIS-7). At the end of treatment, the visual analog scale and Likert scale will be used to measure the individual's satisfaction. Expected results: The 405nm LED in the vaginal canal is expected to be safe and effective for SGM.
- Conditions
- Atrophy;Vaginal
- Being tested
- Light Emitting Diode, Sham Light Emitting Diode
- Keywords
- Phototherapy, Menopause, Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light Emitting DiodeDevice
Blue light-emitting diode applied to the female genital region for eight minutes, for five sessions, one per week
Sham Light Emitting DiodeDevice
Sham Blue light-emitting diode turned off applied to the female genital region for eight minutes, for five sessions, one per week
| Study group | Role | What they receive |
|---|---|---|
| Light Emitting Diode | Experimental | Light Emitting Diode in the Treatment of Menopause Genitourinary Syndrome Receives: Device: Light Emitting Diode |
| Light Emitting Diode Sham | Sham comparator | Light Emitting Diode device Sham - turned off Receives: Device: Sham Light Emitting Diode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal maturation index
Cytological vaginal will be collected at one third lower lateral vaginal wall and quantified superficial, intermediate and basal cells to calculate vaginal maturation index
Measured: Change from baseline at 3 months
Female Sexual Function Index (FSFI) - Female Version (QS-F)
Measure of quality of sex life. Full Scale Score Range 2-36 - The higher final score, better is the sexual function
Measured: Change from baseline at 3 months
Secondary outcomes (7)
Vaginal pH
pH indicator tape
Measured: Change from baseline at 3 months
Urinary symptoms
International Consultation on Incontinence Questionnaire - Short Form (ICIQ Questionary Short Form)-Scoring scale: 0-21 (lower values means better quality of life)
Measured: Change from baseline at 3 months
Visual analog scale
Stratification between 0 and 10 (few symptoms to severe symptoms)
Measured: Change from baseline at 3 months
Female Genital Self-Image Scale - 7 (FGSIS-7)
Measure of quality of sex life. Scores between 7-28 (higher scores indicate better self-image)
Measured: Change from baseline at 3 months]
Likert scale
Satisfaction with the treatment measured between 1 and 5 ( not at all happy with the treatment -very happy with the treatment)
Measured: Change from finished treatment and 3 months after
Sexual Quotients Female Version (QS-F)
Female sex life domain. Scores between 0-100 (higher scores indicate better sex life) Scores between 82-100 score: excellent, 62-80 score: regular, 42-60 score: unfavorable, 22-40 score: regular, 0-20 score: bad
Measured: Change from baseline at 3 months
SF-36
Short Form health survey 36 questionnaire, (0-100) - lower values means worse quality of life
Measured: Change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start1 Dec 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophy;VaginalStudies 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
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patricia Lordelo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Messina
- Responsible party
- Sponsor-investigator, Patricia Lordelo, Centro de Atenção ao Assoalho Pélvico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902794
- Sponsor's protocol ID
- U1111-1201-2342
- Status last verified
- Jun 2023
- First submitted
- 20 May 2021
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light Emitting Diode in the Treatment of Genitourinary Syndrome of Menopause: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04902794
- Acronym / sponsor ID
- U1111-1201-2342
- Conditions
- Atrophy;Vaginal
- Keywords
- Phototherapy, Menopause, Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Patricia LordeloUniversity, hospital or other
- Collaborators
- University of Messina
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 26 May 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.
Introduction: The genitourinary menopause syndrome (MMS) affects 50% of postmenopausal women and, due to a decrease in hormone levels, triggers functional changes in the vagina and vagina, and impairment of quality of life and sexual function. Objective: To test the hypothesis that the 405 nm light emitting diode in the treatment of vulvovaginal atrophy is safe and effective, by reducing the symptomatology of the disease and histological alteration of the tissue. Methods: This is a pilot study in 10 volunteers with SGM, followed by a randomized, blinded trial in a sample of 58 individuals that will be performed at the Pelvic Floor Care Center (CAAP). Menopausal women up to 65 years of age and with clinical signs and symptoms of vulvovaginal atrophy syndrome (vaginal dryness and irritation, pruritus, pain or discomfort in intercourse, bleeding after sexual intercourse) and who voluntarily participate in the study will be included. Will be excluded from the study the patients in hormonal replacement for less than 6 months, diagnosis of vaginal infection, use of pacemaker, pregnant women, those who have performed Oophorectomy or presented ovarian cancer, difficulty understanding the proposed instruments and patients with chronic neurological degenerative diseases. Three 405 nm light emitting diode (LED) sessions will be performed, with a seven days interval between them. In the clinical trial, the study group will perform kinesiotherapy and LED.
The control group will perform kinesiotherapy and the LED will be turned off. Data collection will be performed initially and after the sessions through self-administered questionnaires containing socio-demographic and clinical information, Medical Outcomes Study 36, Short-Form Health Survey (SF-36), Female Sexual Function Index (FSFI) - Female Version (QS-F), Female Genital Self-Image Scale - 7 (FGSIS-7). At the end of treatment, the visual analog scale and Likert scale will be used to measure the individual's satisfaction. Expected results: The 405nm LED in the vaginal canal is expected to be safe and effective for SGM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light Emitting Diode | Experimental | Device: Light Emitting DiodeLight Emitting Diode in the Treatment of Menopause Genitourinary Syndrome |
| Light Emitting Diode Sham | Sham comparator | Device: Sham Light Emitting DiodeLight Emitting Diode device Sham - turned off |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- menopausal women up to 65 years of age
- presence of clinical signs and symptoms of Menopause Genitourinary Syndrome :dryness and irritation of the vagina, pruritus, pain or discomfort in sexual intercourse, bleeding after sexual intercourse
- voluntarily participate in the research.
Key exclusion criteria (4 listed)
- patients undergoing hormone replacement for less than 6 months
- diagnosis of vaginal infection
- difficulty in understanding the proposed instruments
- patients with chronic neurological degenerative diseases.
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 |
|---|---|---|
| Light Emitting DiodeBlue light-emitting diode applied to the female genital region for eight minutes, for five sessions, one per week | Device | Light Emitting Diode |
| Sham Light Emitting DiodeSham Blue light-emitting diode turned off applied to the female genital region for eight minutes, for five sessions, one per week | Device | Light Emitting Diode Sham |
Primary outcome
Vaginal maturation index
Time frame: Change from baseline at 3 months
Cytological vaginal will be collected at one third lower lateral vaginal wall and quantified superficial, intermediate and basal cells to calculate vaginal maturation index
Female Sexual Function Index (FSFI) - Female Version (QS-F)
Time frame: Change from baseline at 3 months
Measure of quality of sex life. Full Scale Score Range 2-36 - The higher final score, better is the sexual function
7 secondary outcomes
Vaginal pH
Time frame: Change from baseline at 3 months
Urinary symptoms
Time frame: Change from baseline at 3 months
Visual analog scale
Time frame: Change from baseline at 3 months
Female Genital Self-Image Scale - 7 (FGSIS-7)
Time frame: Change from baseline at 3 months]
Likert scale
Time frame: Change from finished treatment and 3 months after
Sexual Quotients Female Version (QS-F)
Time frame: Change from baseline at 3 months
SF-36
Time frame: Change from baseline at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light Emitting Diode in people with Atrophy;Vaginal, run by Patricia Lordelo 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Jun 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrícia Lôrdelo (557188592400/3330- 1640, pvslordelo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal maturation index (time frame: Change from baseline at 3 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 23 Jun 2023.