Postmenopausal SymptomsPhase 1/2NCT05557799
Photobiomodulation in Post Menopause Genitourinary Syndrome
A Phase 1/2 study testing Photobiomodulation in people with Postmenopausal Symptoms, run by University of Nove de Julho.
Trial summary
The goal of this project is to evaluate the clinical response of patients with symptoms of genitourinary menopause syndrome after the application of photobiomodulation in the vagina and its introit. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Symptoms
- What is being tested?
- Photobiomodulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2022to 30 Jul 2023
- Phase
- Phase 1/2
- 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women over 50 years of age who are in the postmenopausal period (amenorrhea for at least 12 months, with no pathology involved);
- With one or more symptoms of UGS (dyspareunia, dryness, irritation and vaginal burning and/or discomfort, vaginal atrophy, vaginal and vulvar dryness, dysuria, frequency, recurrent urinary infections);
- With complaints of stress and/or urge urinary incontinence;
- Who have cervical cytopathology (Pap smear) within the normal range performed in the last year and are not in use of hormonal medication to treat menopausal symptoms in the last 6 months.
Who cannot join
- Participants with explicit refusal of the patient to participate in the researc;
- History of bilateral oophorectomy and diseases such as: recent AMI (Acute Myocardial Infarction), neoplasms, history of thrombosis, liver failure, uncontrolled genital bleeding, genital condylomatosis, active genital herpes, lower genital tract surgeries that make treatment impossible.
About this study
Official title: Photobiomodulation in Post Menopause Genitourinary Syndrome - Study Protocol for a Randomized, Double-blind, Controlled Clinical Trial
The goal of this project is to evaluate the clinical response of patients with symptoms of genitourinary menopause syndrome after the application of photobiomodulation in the vagina and its introit. METHOD: In this randomized, double-blind, placebo-controlled study protocol, women over 50 years of age who are in the postmenopausal period (amenorrhea for at least 12 months, with no pathology involved) with one or more symptoms of PGS will be selected. Participants included in the study will be randomly divided into two groups: group A, which will receive photobiomodulation with a vaginal diode laser and its introit and group B (placebo) with the laser device turned off. Both treatments will be maintained for 4 consecutive weeks.The treatment group (n=30) will receive four consecutive applications, using laser diode DMC (808 nm), 4J per point, 100mW of power, 510mW/cm², beam area of 0.2cm², 8 sites in the external vagina, for the 40s in each site, once per week for 4 weeks. The Placebo Group (n=30) will be handled as treated, but with the laser turned off. Quality of life will be analyzed using the female sexual functioning index (FSFI-6), the urinary incontinence questionnaire (ICIQ-SF), the intensity of menopausal symptoms will be evaluated using a visual analogue scale (VAS), the vulvo vaginal atrophy will be measured by the Vaginal Health Index (VHI) and compared between groups. Also, the vaginal temperature will be measured using a thermal camera, as well as the pressure of the pelvic floor force (vaginal dynamometer) and a 1-hour Pad Test will be performed to quantify the urinary loss. The data will be tested for normality using the Shapiro Wilks test and, if they present a parametric distribution, they will be represented by means of their respective means and standard deviations.
- Conditions
- Postmenopausal Symptoms
- Being tested
- Photobiomodulation, Placebo Photobiomodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationRadiation
The treatment group will receive four consecutive applications, using laser diode DMC (808 nm), 4J per point, 100mW of power, 510mW/cm², beam area of 0.2cm², 8 sites in the external vagina, for 40s in each site, once per week for 4 weeks.
Placebo PhotobiomodulationRadiation
The Placebo Group will receive the same four consecutive applications, but with the laser turned off.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation group | Active comparator | Participants in this group will receive photobiomodulation with a vaginal diode laser and its introit. Receives: Radiation: Photobiomodulation |
| Placebo group | Placebo comparator | Participants in this group will receive simulated photobiomodulation, with the laser device turned off. Receives: Radiation: Placebo Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Female Sexual Function Index (FSFI)
The FSFI or female sexual function index is a specific and multidimensional questionnaire to assess female sexual response, accessing 6 domains: desire, arousal, lubrication, orgasm, satisfaction and pain evaluated in 19 questions about sexual activity in the last 4 weeks. In order to obtain the total score of the scale, the scores for each domain are added up, and for higher scores, better sexual function is considered, and the threshold for sexual dysfunction is a score of 2678. Based on the value of the total score, it would be possible discriminate between populations at higher and lower risk of experiencing sexual dysfunction.
Measured: Baseline and the 4 weeks of treatment.
Secondary outcomes (7)
Changes in the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
This questionnaire has a score from zero to 21 points, with zero indicating the absence of symptoms and the greater the sum of the points, the greater the impact and severity of urinary incontinence (UI) symptoms. The maximum sum of the response values indicates a score of 21 points, referring to a high impact of UI on the individual's life.
Measured: Baseline and the 4 weeks of treatment.
Changes in the Vaginal Health Index Score
It consists of a clinical analysis during the speculum examination of 5 parameters: elasticity, pH, mucosal appearance, humidity and the presence of vaginal secretion. Each aspect evaluated receives a score, which varies from 1 to 5. The score may vary from 5 to 25, and a diagnosis of Vulvo Vaginal Atrophy (VVA) is considered when the values are less than or equal to 15, the maximum score of 25 points means absence of clinical signs of vulvovaginal atrophy. This assessment will be performed by a qualified professional during the physical examination.
Measured: Baseline and the 4 weeks of treatment.
Changes in the Vaginal pH
The evaluation of the vaginal pH will be carried out through a pH indicator strip, which when inserted in the middle third of the vagina in contact with the mucosa, has the color of the strip changed. Measurement of the vaginal cul-de-sac is avoided, because contact with mucus, blood or semen can alter the reading. The nitrazine tape must remain in contact with the vaginal wall for 5 seconds for later checking the pH on the colorimetric scale provided by the manufacturer. Normal vaginal pH is acidic, during menacme, it should be maintained between 3.8 and 4.5.
Measured: Baseline and the 4 weeks of treatment.
Changes in Pain using a Visual Analog Scale (VAS)
A VAS will be used to evaluate the vaginal complaints of the participants. They will receive a figure of a ruler with marks from 0 to 10, whose one end indicates complete absence of symptoms and the other indicates the worst possible symptom. For analysis of the Visual and Analog Scale of Symptoms of Genitourinary Syndrome (GUS) (VAS - SGU), the sum of one to twelve points will classify the symptoms from mild to severe.
Measured: Baseline and the 4 weeks of treatment.
Changes in the Pelvic Floor Muscles (PFMs)
The pressure sensor (dynamometer) will be introduced into the vaginal canal, and the resting vaginal pressure (resting muscles) will be quantified. The device will be calibrated, zeroed and it will be asked for the participant to contract their PFMs inwards and upwards as hard as possible 3 times and maintain the contraction for at least five seconds (maximum vaginal pressure), with an interval of 30 seconds between each pull.
Measured: Baseline and once a week for 4 weeks
Changes in Urinary Loss using Ped-Test
The procedure for performing the Ped-test will be as follows: initially, the participant will be asked to place an absorbent with a previously measured weight close to the external urethral meatus. Then, she will be given a 500 mL bottle of water to drink and wait for 15 minutes. Afterwards, the participant will be asked to perform some actions simulating activities of daily living. After carrying out the proposed activities, the absorbent will be removed and weighed on a precision scale, with a minimum reading of 0.1 mg and a maximum capacity of 220 g. Urinary losses are evaluated and classified as follows: losses of up to 1 g are considered insignificant; between 1.1 and 9.9 g are classified as light losses; between 10 and 49.9 g are moderate losses; and above 50 g, severe losses.
Measured: Baseline, the 4 weeks of treatment and 90 days after treatment.
Changes in Vulva Temperature
The temperature of the vulva, in Celsius degrees, will be evaluated at the eight points of radiation in the vulvar region, with a digital infrared thermometer, which will allow measurement without physical contact. The average of the eight readings will be calculated before and after the diode laser procedure in the 4 consecutive weekly sessions.
Measured: Baseline and and once a week for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start30 Oct 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jul 2023 (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 SymptomsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557799
- Sponsor's protocol ID
- SGPM
- Status last verified
- Sep 2022
- First submitted
- 23 Sep 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pereira SRDS, Mesquita-Ferrari RA, Salviatto LTC, Bezerra CDDS, Dalapria V, Mello EDS, Almeida-Lopes L, Bossini PS, Goncalves MLL, Deana AM. Photobiomodulation in post menopause genitourinary syndrome-Study protocol for a randomized, double-blind, controlled clinical protocol. PLoS One. 2024 Dec 2;19(12):e0313324. doi: 10.1371/journal.pone.0313324. eCollection 2024.
PubMed 39621728
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation in Post Menopause Genitourinary Syndrome - Study Protocol for a Randomized, Double-blind, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05557799
- Acronym / sponsor ID
- SGPM
- Conditions
- Postmenopausal Symptoms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 30 Oct 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 28 Sep 2022 (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.
The goal of this project is to evaluate the clinical response of patients with symptoms of genitourinary menopause syndrome after the application of photobiomodulation in the vagina and its introit. METHOD: In this randomized, double-blind, placebo-controlled study protocol, women over 50 years of age who are in the postmenopausal period (amenorrhea for at least 12 months, with no pathology involved) with one or more symptoms of PGS will be selected. Participants included in the study will be randomly divided into two groups: group A, which will receive photobiomodulation with a vaginal diode laser and its introit and group B (placebo) with the laser device turned off. Both treatments will be maintained for 4 consecutive weeks.The treatment group (n=30) will receive four consecutive applications, using laser diode DMC (808 nm), 4J per point, 100mW of power, 510mW/cm², beam area of 0.2cm², 8 sites in the external vagina, for the 40s in each site, once per week for 4 weeks. The Placebo Group (n=30) will be handled as treated, but with the laser turned off. Quality of life will be analyzed using the female sexual functioning index (FSFI-6), the urinary incontinence questionnaire (ICIQ-SF), the intensity of menopausal symptoms will be evaluated using a visual analogue scale (VAS), the vulvo vaginal atrophy will be measured by the Vaginal Health Index (VHI) and compared between groups. Also, the vaginal temperature will be measured using a thermal camera, as well as the pressure of the pelvic floor force (vaginal dynamometer) and a 1-hour Pad Test will be performed to quantify the urinary loss. The data will be tested for normality using the Shapiro Wilks test and, if they present a parametric distribution, they will be represented by means of their respective means and standard deviations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation group | Active comparator | Radiation: PhotobiomodulationParticipants in this group will receive photobiomodulation with a vaginal diode laser and its introit. |
| Placebo group | Placebo comparator | Radiation: Placebo PhotobiomodulationParticipants in this group will receive simulated photobiomodulation, with the laser device turned off. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women over 50 years of age who are in the postmenopausal period (amenorrhea for at least 12 months, with no pathology involved);
- With one or more symptoms of UGS (dyspareunia, dryness, irritation and vaginal burning and/or discomfort, vaginal atrophy, vaginal and vulvar dryness, dysuria, frequency, recurrent urinary infections);
- With complaints of stress and/or urge urinary incontinence;
- Who have cervical cytopathology (Pap smear) within the normal range performed in the last year and are not in use of hormonal medication to treat menopausal symptoms in the last 6 months.
Key exclusion criteria (2 listed)
- Participants with explicit refusal of the patient to participate in the researc;
- History of bilateral oophorectomy and diseases such as: recent AMI (Acute Myocardial Infarction), neoplasms, history of thrombosis, liver failure, uncontrolled genital bleeding, genital condylomatosis, active genital herpes, lower genital tract surgeries that make treatment impossible.
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 |
|---|---|---|
| PhotobiomodulationThe treatment group will receive four consecutive applications, using laser diode DMC (808 nm), 4J per point, 100mW of power, 510mW/cm², beam area of 0.2cm², 8 sites in the external vagina, for 40s in each site, once per week for 4 weeks. | Radiation | Photobiomodulation group |
| Placebo PhotobiomodulationThe Placebo Group will receive the same four consecutive applications, but with the laser turned off. | Radiation | Placebo group |
Primary outcome
Changes in the Female Sexual Function Index (FSFI)
Time frame: Baseline and the 4 weeks of treatment.
The FSFI or female sexual function index is a specific and multidimensional questionnaire to assess female sexual response, accessing 6 domains: desire, arousal, lubrication, orgasm, satisfaction and pain evaluated in 19 questions about sexual activity in the last 4 weeks. In order to obtain the total score of the scale, the scores for each domain are added up, and for higher scores, better sexual function is considered, and the threshold for sexual dysfunction is a score of 2678. Based on the value of the total score, it would be possible discriminate between populations at higher and lower risk of experiencing sexual dysfunction.
7 secondary outcomes
Changes in the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
Time frame: Baseline and the 4 weeks of treatment.
Changes in the Vaginal Health Index Score
Time frame: Baseline and the 4 weeks of treatment.
Changes in the Vaginal pH
Time frame: Baseline and the 4 weeks of treatment.
Changes in Pain using a Visual Analog Scale (VAS)
Time frame: Baseline and the 4 weeks of treatment.
Changes in the Pelvic Floor Muscles (PFMs)
Time frame: Baseline and once a week for 4 weeks
Changes in Urinary Loss using Ped-Test
Time frame: Baseline, the 4 weeks of treatment and 90 days after treatment.
Changes in Vulva Temperature
Time frame: Baseline and and once a week for 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Derived from this study: PubMed 39621728Pereira SRDS, Mesquita-Ferrari RA, Salviatto LTC, Bezerra CDDS, Dalapria V, Mello EDS, Almeida-Lopes L, Bossini PS, Goncalves MLL, Deana AM. Photobiomodulation in post menopause genitourinary syndrome-Study protocol for a randomized, double-blind, controlled clinical protocol. PLoS One. 2024 Dec 2;19(12):e0313324. doi: 10.1371/journal.pone.0313324. eCollection 2024.
Related trials for Postmenopausal Symptoms
Not yet recruitingPhase 4
Migraine Menopause Study
Migraine, Menopausal
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
Recruiting
The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.
Poor Sleep Quality, Gut Microbiome
RecruitingPhase 2
A Clinical Trial Comparing the Efficacy and Safety of Different Doses of BL0175 Injection in Treating Postmenopausal Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced or Metastatic Breast Cancer
Breast Cancer (Locally Advanced or Metastatic)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Photobiomodulation in people with Postmenopausal Symptoms, run by University of Nove de Julho.
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 4 inclusion and 2 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 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Changes in the Female Sexual Function Index (FSFI) (time frame: Baseline and the 4 weeks of treatment.). 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 NCT05557799, 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 28 Sep 2022.