Vaginal DrynessPRV01NCT04342559
Acceptability, Under Use in Real Conditions Of Two Vaginal Moistures Indicated for Women With Vaginal Drying
A study testing Belamy (vaginal moisturizer) in people with Vaginal Dryness, run by Libbs Farmacêutica LTDA at 1 site in Brazil.
Trial summary
The studies carried out to evaluate the safety and efficacy of products aimed at the intimate area of women aim to confirm the absence of risk associated with its use, identify possible feelings of discomfort and / or clinical signs resulting from the use of the product and evaluate the benefits provided by the use of… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Dryness
- What is being tested?
- Belamy (vaginal moisturizer)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Apr 2020to 6 Apr 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy research participants with an active sex life;
- Skin and intact mucosa in the test region;
- Agreement to adhere to the study's procedures and requirements and to attend the institute on the day (s) and time (s) determined for the assessments;
- Ability to consent to their participation in the study;
- Female research participants;
- Menopausal participants of any age;
- Participants who complain of vaginal dryness, classified at least as mild, and who present at least one of the following symptoms, in addition to vaginal dryness, also classified at least as mild (pain during or shortly after intercourse or discomfort during or soon after sexual intercourse).
Who cannot join
- Have used moisturizing creams and / or vaginal lubricants 05 days before the initial study visit;
- Vaginal pathology in the product application area;
- Have had sex less than 48 hours before the visit;
- Have been diagnosed with urogenital or vaginal infection in the last 30 days;
- Have used topical or systemic antibiotics, antifungals, hormone-based creams or treatment for vaginal atrophy in the last six weeks;
- Immune failure;
Show all 10Show fewer
- Current use of the following medications for topical or systemic use: corticosteroids, immunosuppressants and antihistamines and in the last 7 days;
- History of reaction to the category of the product tested;
- Present vaginal bleeding on the day of visits;
- Other diseases or medications that may directly interfere with the study result or endanger the health of the research participant, at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Of Acceptability, Under Use in Real Conditions Of Two Vaginal Moistures ( 06260308 ) Indicated for Women With Vaginal Drying
The studies carried out to evaluate the safety and efficacy of products aimed at the intimate area of women aim to confirm the absence of risk associated with its use, identify possible feelings of discomfort and / or clinical signs resulting from the use of the product and evaluate the benefits provided by the use of the product such as, gynecologically tested, clinically tested, hydration for 72 hours, hydration, does not drip or drip little, feeling of natural hydration, control of natural vaginal odor, preserves vaginal pH, does not promote irritation, use vaginal topic, feeling of comfort, relief from dryness, easy use of the applicator, the applicator does not cause discomfort during application, preferably use at night, does not change the vaginal flora, reduces pain and discomfort during or shortly after sexual intercourse, does not promote discomfort during or shortly after intercourse, reduction of vaginal bleeding during or right after sexual intercourse, if there is a small amount left in the applicator, the treatment is not compromised.
The research will be carried out with two new products for use in the internal intimate region in up to 74 research participants (up to 37 participants per product - each group of 37 will use one of the products), which meet the required inclusion and exclusion criteria. At the end of the treatment, the analysis must contain a minimum number of 30 participants per product. Participants will use the test products for 22 (+ 2) days and will be evaluated and monitored throughout the study by a gynecologist to verify the effectiveness of the products and possible adverse events. In addition, a profile questionnaire will be applied at the beginning of the study (T0 - day 1) and at the end of the study, the perceived efficacy questionnaire (T22), to assess signs and symptoms of the efficacy and safety of the product used.
Read the detailed description
Moisturizers are used in chronic maintenance, replacing normal vaginal sections.
Vaginal moisturizers rehydrate the mucosal tissue and are absorbed by the skin, adhering to the vaginal lining, thus mimicking natural vaginal secretions. The use of vaginal moisturizers is intended to allow dryness / atrophy, vaginitis / non-hormonal vaginal atrophy and is regularly harmful or once every 2-3 days. The frequency of use is directly proportional to the severity of the atrophy (for example, the more severe the atrophy, the more frequent the application is), the effects of the moisturizer are more prolonged and the effects of the lubricant, lasting 2 to 3 days.
MOD_PRO_CEP Rev. 03 All-SE-UG-EP-pH-FL-062603-07 / 08-04-18-PRV01 Vaginal moisturizers use this longer to change the content of the endothelium fluid, capture the vaginal pH and thus maintain vaginal hydration and acidity. Therefore, they are particularly beneficial, not only for women with VVA / GSM symptoms that cause pain during intercourse, but also for women who are not currently sexually active, but experience discomfort on a daily basis. Since vaginal moisturizers are used to moisturize the mucosa, most contain water. For the water to stick to the mucosa, it also contains vegetable or synthetic polymers. In addition, they can use a wide variety of other excipients to provide adequate viscosity, to buffer or pH and for conservation; these additional ingredients (some synthetic polymers) affect the pH and osmolality of the moisturizer.
The products to be tested in this study are two vaginal moisturizers. These are two new products from the sponsor.
- Conditions
- Vaginal Dryness
- Being tested
- Belamy (vaginal moisturizer)
- Keywords
- vaginal hydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belamy (vaginal moisturizer)Other
The conformity of the product use by the research participants will be verified through the filling of the product use diary by the research participants and also by the accounting of the tubes not used in T22.
Interdiction and Restriction
- Keep the test product tightly closed, protected from heat, moisture and out of the reach of children;
- Do not apply any other product to the genital area. Only the use of soap normally used for hygiene will be allowed;
- Do not change genital / vaginal hygiene habits;
- Not having sexual intercourse in the 48 hours (2 days) before the research visits;
- Do not perform a hygienic shower in the genital region within 24 hours (1 day) prior to the research visits;
- Do not perform gynecological / intimate showers during the study period
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Belamy with sinodor Vaginal Moisturizer with Odor Neutralizer - code: 062603-07
Participants will be instructed on how to use it as follows:
Guidance The product has individual pre-filled applicators for single use and disposable after use. The applicator has an anatomical shape, in order to facilitate use, avoiding discomfort during application.
A single application should be performed every 3 days (72 hours). I use it at night, before going to bed, before going to sleep. Receives: Other: Belamy (vaginal moisturizer) |
| Group II | Experimental | Belamy without sinodor Vaginal Moisturizer without Odor Neutralizer - code: 062603-08
Participants will be instructed on how to use it as follows:
Guidance The product has individual pre-filled applicators for single use and disposable after use. The applicator has an anatomical shape, in order to facilitate use, avoiding discomfort during application.
A single application should be performed every 3 days (72 hours). I use it at night, before going to bed, before going to sleep. Receives: Other: Belamy (vaginal moisturizer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of clinical signs (Visual gynecological examination)
Visual examination of the vulva, vagina and cervix using a speculum. Objective vaginal signs will be described, such as: inflammation, edema, presence of abrasions and presence of deepithelialization of the vaginal mucosa in the initial (T0 - Day 1).Each clinical sign will be classified using a scale from 0 to 3 from the best to the worst scenario (0 - Absent, 1 - Mild, 2 - Moderate or 3 - Intense).
Measured: day 1
Intensity of clinical signs (Visual gynecological examination)
Visual examination of the vulva, vagina and cervix using a speculum. Objective vaginal signs will be described, such as: inflammation, edema, presence of abrasions and presence of deepithelialization of the vaginal mucosa in the final (T22- Day 22).Each clinical sign will be classified using a scale from 0 to 3 from the best to the worst scenario (0 - Absent, 1 - Mild, 2 - Moderate or 3 - Intense).
Measured: day 22
Vaginal pH measurements
Before using the product (T0 - day 1), the vaginal pH will be evaluated, with the aid of a speculum, using colorimetric pH measuring tapes, with a gradual scale of 2 to 9.
The tapes will be applied in contact with the right lateral vaginal wall, without touching the cervix or cervical mucus, due to the pH difference. The cervix, as well as the cervical mucus, have a pH more alkaline than the vagina, and may interfere with the result that will be evaluated by colorimetric approximation using the standard template
Measured: day 1
Vaginal pH measurements
Before using the product after 22 + 2 days (T22), the vaginal pH will be evaluated, with the aid of a speculum, using colorimetric pH measuring tapes, with a gradual scale of 2 to 9.
The tapes will be applied in contact with the right lateral vaginal wall, without touching the cervix or cervical mucus, due to the pH difference. The cervix, as well as the cervical mucus, have a pH more alkaline than the vagina, and may interfere with the result that will be evaluated by colorimetric approximation using the standard template
Measured: day 22
Bacterioscopic collection
Before using the product (T0 - day 1) and after 22 + 2 days (T22), the bacterioscopic collection of vaginal secretion will be performed to quantify the microorganisms present in it in order to assess the non-interference of the use of the product in the flora vaginal.
The collection of vaginal material from the participants will be performed by a gynecologist with the insertion of a speculum in the vagina. The excess cervical mucus will be removed with the aid of MOD_PRO_CEP Rev. 03 All-SE-UG-EP-pH-FL-062603-07 / 08-04-18-PRV01 cotton swab. Then, the swabs indicated for collection will be inserted and rotated for a few seconds on the bottom of the vaginal sac.The swabs containing the samples will be immediately placed in sterile test tubes and sent to the laboratory for microbiological analysis.
Measured: days 1 and 22
Visual assessment of product accumulation in the mucosa
Visual assessment of accumulation of product adhered to the mucosa will be performed after 72 hours or more, considering the study window (+2 days), without using the product (T22):
0: Absent
- Little buildup
- Moderate accumulation
- Intense accumulation
Measured: after 72 hours
Vaginal Health Index
Classification by the gynecologist of the parameters present in the vaginal health score (Vaginal Health Index) before and after using the product (T0 - day 1 and T22 + 2 days), as shown below.
During the specular examination, a vaginal health index will be evaluated by the gynecologist, with scores from 1 to 5. A lower score corresponds to greater urogenital atrophy (worse outcome)
Measured: after 72 hours
Teste de Contato (patch test)
If, during the research, any participant has an adverse reaction such as contact dermatitis, they will be subjected to epicutaneous tests. The evaluation scale to be used will be the scale recommended by the International Contact Dermatitis Investigator Group - ICDRG -
Measured: up to 22 day
Secondary outcomes (3)
Evaluation of Effectiveness Perceived by Research Participants
Before using the product (T0 - day 1) of use, the research participants will be instructed to self-assess themselves through of questionnaires.A point scale will be used, using a numerical scale (0 to 4) to assess this perception (0 - worse outcome to 4-better outcome)
Measured: day 1
Evaluation of Effectiveness Perceived by Research Participants
Before using the product after 22 + 2 days (T22) of use, or only after using the product (T22), the research participants will be instructed to self-assess themselves through of questionnaires.A point scale will be used, using a numerical scale (0 to 4) to assess this perception (0 - worse outcome to 4-better outcome)
Measured: day 22
Rate of Gynecological Adverse Reactions
All reactions will be classified according to their intensity, according to the classification below (From best -mild to worst scenario -intense):
Mild: Awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with the participant's usual functions or normal daily activities.
Moderate: enough discomfort present to cause interference with a part of the participant's usual functions or normal daily activities.
Intense: Extreme difficulty, causing significant damage to functioning or disability; significantly interferes with the participant's usual functions; prevents normal daily activities.
Measured: up to 22 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start6 Apr 2020
- Primary completion6 Apr 2020
- Study completion6 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DrynessStudies 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
- Open, non-comparative clinical study.
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Libbs Farmacêutica LTDA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342559
- Sponsor's protocol ID
- AllSEUGEPpHFL06260307080418
- Acronym
- PRV01
- Status last verified
- Apr 2020
- First submitted
- 6 Apr 2020
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Acceptability, Under Use in Real Conditions Of Two Vaginal Moistures ( 06260308 ) Indicated for Women With Vaginal Drying
- ClinicalTrials.gov ID
- NCT04342559
- Acronym / sponsor ID
- PRV01 / AllSEUGEPpHFL06260307080418
- Conditions
- Vaginal Dryness
- Keywords
- vaginal hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Libbs Farmacêutica LTDAIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 13 Apr 2020 (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 studies carried out to evaluate the safety and efficacy of products aimed at the intimate area of women aim to confirm the absence of risk associated with its use, identify possible feelings of discomfort and / or clinical signs resulting from the use of the product and evaluate the benefits provided by the use of the product such as, gynecologically tested, clinically tested, hydration for 72 hours, hydration, does not drip or drip little, feeling of natural hydration, control of natural vaginal odor, preserves vaginal pH, does not promote irritation, use vaginal topic, feeling of comfort, relief from dryness, easy use of the applicator, the applicator does not cause discomfort during application, preferably use at night, does not change the vaginal flora, reduces pain and discomfort during or shortly after sexual intercourse, does not promote discomfort during or shortly after intercourse, reduction of vaginal bleeding during or right after sexual intercourse, if there is a small amount left in the applicator, the treatment is not compromised.
The research will be carried out with two new products for use in the internal intimate region in up to 74 research participants (up to 37 participants per product - each group of 37 will use one of the products), which meet the required inclusion and exclusion criteria. At the end of the treatment, the analysis must contain a minimum number of 30 participants per product. Participants will use the test products for 22 (+ 2) days and will be evaluated and monitored throughout the study by a gynecologist to verify the effectiveness of the products and possible adverse events. In addition, a profile questionnaire will be applied at the beginning of the study (T0 - day 1) and at the end of the study, the perceived efficacy questionnaire (T22), to assess signs and symptoms of the efficacy and safety of the product used.
Detailed description
Moisturizers are used in chronic maintenance, replacing normal vaginal sections.
Vaginal moisturizers rehydrate the mucosal tissue and are absorbed by the skin, adhering to the vaginal lining, thus mimicking natural vaginal secretions. The use of vaginal moisturizers is intended to allow dryness / atrophy, vaginitis / non-hormonal vaginal atrophy and is regularly harmful or once every 2-3 days. The frequency of use is directly proportional to the severity of the atrophy (for example, the more severe the atrophy, the more frequent the application is), the effects of the moisturizer are more prolonged and the effects of the lubricant, lasting 2 to 3 days.
MOD_PRO_CEP Rev. 03 All-SE-UG-EP-pH-FL-062603-07 / 08-04-18-PRV01 Vaginal moisturizers use this longer to change the content of the endothelium fluid, capture the vaginal pH and thus maintain vaginal hydration and acidity. Therefore, they are particularly beneficial, not only for women with VVA / GSM symptoms that cause pain during intercourse, but also for women who are not currently sexually active, but experience discomfort on a daily basis. Since vaginal moisturizers are used to moisturize the mucosa, most contain water. For the water to stick to the mucosa, it also contains vegetable or synthetic polymers. In addition, they can use a wide variety of other excipients to provide adequate viscosity, to buffer or pH and for conservation; these additional ingredients (some synthetic polymers) affect the pH and osmolality of the moisturizer.
The products to be tested in this study are two vaginal moisturizers. These are two new products from the sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open, non-comparative clinical study.
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Belamy (vaginal moisturizer)Belamy with sinodor Vaginal Moisturizer with Odor Neutralizer - code: 062603-07 Participants will be instructed on how to use it as follows: Guidance The product has individual pre-filled applicators for single use and disposable after use. The applicator has an anatomical shape, in order to facilitate use, avoiding discomfort during application. A single application should be performed every 3 days (72 hours). I use it at night, before going to bed, before going to sleep. |
| Group II | Experimental | Other: Belamy (vaginal moisturizer)Belamy without sinodor Vaginal Moisturizer without Odor Neutralizer - code: 062603-08 Participants will be instructed on how to use it as follows: Guidance The product has individual pre-filled applicators for single use and disposable after use. The applicator has an anatomical shape, in order to facilitate use, avoiding discomfort during application. A single application should be performed every 3 days (72 hours). I use it at night, before going to bed, before going to sleep. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy research participants with an active sex life;
- Skin and intact mucosa in the test region;
- Agreement to adhere to the study's procedures and requirements and to attend the institute on the day (s) and time (s) determined for the assessments;
- Ability to consent to their participation in the study;
- Female research participants;
Key exclusion criteria (10 listed)
- Have used moisturizing creams and / or vaginal lubricants 05 days before the initial study visit;
- Vaginal pathology in the product application area;
- Have had sex less than 48 hours before the visit;
- Have been diagnosed with urogenital or vaginal infection in the last 30 days;
- Have used topical or systemic antibiotics, antifungals, hormone-based creams or treatment for vaginal atrophy in the last six weeks;
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 |
|---|---|---|
| Belamy (vaginal moisturizer)The conformity of the product use by the research participants will be verified through the filling of the product use diary by the research participants and also by the accounting of the tubes not used in T22. Interdiction and Restriction * Keep the test product tightly closed, protected from heat, moisture and out of the reach of children; * Do not apply any other product to the genital area. Only the use of soap normally used for hygiene will be allowed; * Do not change genital / vaginal hygiene habits; * Not having sexual intercourse in the 48 hours (2 days) before the research visits; * Do not perform a hygienic shower in the genital region within 24 hours (1 day) prior to the research visits; * Do not perform gynecological / intimate showers during the study period | Other | Group I, Group II |
Primary outcome
Intensity of clinical signs (Visual gynecological examination)
Time frame: day 1
Visual examination of the vulva, vagina and cervix using a speculum. Objective vaginal signs will be described, such as: inflammation, edema, presence of abrasions and presence of deepithelialization of the vaginal mucosa in the initial (T0 - Day 1).Each clinical sign will be classified using a scale from 0 to 3 from the best to the worst scenario (0 - Absent, 1 - Mild, 2 - Moderate or 3 - Intense).
Intensity of clinical signs (Visual gynecological examination)
Time frame: day 22
Visual examination of the vulva, vagina and cervix using a speculum. Objective vaginal signs will be described, such as: inflammation, edema, presence of abrasions and presence of deepithelialization of the vaginal mucosa in the final (T22- Day 22).Each clinical sign will be classified using a scale from 0 to 3 from the best to the worst scenario (0 - Absent, 1 - Mild, 2 - Moderate or 3 - Intense).
Vaginal pH measurements
Time frame: day 1
Before using the product (T0 - day 1), the vaginal pH will be evaluated, with the aid of a speculum, using colorimetric pH measuring tapes, with a gradual scale of 2 to 9. The tapes will be applied in contact with the right lateral vaginal wall, without touching the cervix or cervical mucus, due to the pH difference. The cervix, as well as the cervical mucus, have a pH more alkaline than the vagina, and may interfere with the result that will be evaluated by colorimetric approximation using the standard template
Vaginal pH measurements
Time frame: day 22
Before using the product after 22 + 2 days (T22), the vaginal pH will be evaluated, with the aid of a speculum, using colorimetric pH measuring tapes, with a gradual scale of 2 to 9. The tapes will be applied in contact with the right lateral vaginal wall, without touching the cervix or cervical mucus, due to the pH difference. The cervix, as well as the cervical mucus, have a pH more alkaline than the vagina, and may interfere with the result that will be evaluated by colorimetric approximation using the standard template
Bacterioscopic collection
Time frame: days 1 and 22
Before using the product (T0 - day 1) and after 22 + 2 days (T22), the bacterioscopic collection of vaginal secretion will be performed to quantify the microorganisms present in it in order to assess the non-interference of the use of the product in the flora vaginal. The collection of vaginal material from the participants will be performed by a gynecologist with the insertion of a speculum in the vagina. The excess cervical mucus will be removed with the aid of MOD_PRO_CEP Rev. 03 All-SE-UG-EP-pH-FL-062603-07 / 08-04-18-PRV01 cotton swab. Then, the swabs indicated for collection will be inserted and rotated for a few seconds on the bottom of the vaginal sac.The swabs containing the samples will be immediately placed in sterile test tubes and sent to the laboratory for microbiological analysis.
Visual assessment of product accumulation in the mucosa
Time frame: after 72 hours
Visual assessment of accumulation of product adhered to the mucosa will be performed after 72 hours or more, considering the study window (+2 days), without using the product (T22): 0: Absent 1. Little buildup 2. Moderate accumulation 3. Intense accumulation
Vaginal Health Index
Time frame: after 72 hours
Classification by the gynecologist of the parameters present in the vaginal health score (Vaginal Health Index) before and after using the product (T0 - day 1 and T22 + 2 days), as shown below. During the specular examination, a vaginal health index will be evaluated by the gynecologist, with scores from 1 to 5. A lower score corresponds to greater urogenital atrophy (worse outcome)
Teste de Contato (patch test)
Time frame: up to 22 day
If, during the research, any participant has an adverse reaction such as contact dermatitis, they will be subjected to epicutaneous tests. The evaluation scale to be used will be the scale recommended by the International Contact Dermatitis Investigator Group - ICDRG -
3 secondary outcomes
Evaluation of Effectiveness Perceived by Research Participants
Time frame: day 1
Evaluation of Effectiveness Perceived by Research Participants
Time frame: day 22
Rate of Gynecological Adverse Reactions
Time frame: up to 22 day
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 13 Apr 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Belamy (vaginal moisturizer) in people with Vaginal Dryness, run by Libbs Farmacêutica LTDA 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 7 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 13 Apr 2020. 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?
Intensity of clinical signs (Visual gynecological examination) (time frame: day 1). The study lists 8 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 13 Apr 2020.