Atrophic VaginitisNCT04247022
Evaluation of Gynecological Acceptability of a Health Care Product
A study testing Health care product (intimate gel) in people with Atrophic Vaginitis and Vaginal Diseases, run by Herbarium Laboratorio Botanico Ltda at 1 site in Brazil.
Trial summary
The research will be conducted with a product for use in the intimate region in up to 75 research participants who will use the investigational product for 28 ± 2 days. Will be evaluated and followed up throughout the study by a gynecologist to verify the safety and effectiveness of the product and possible adverse… Read more about this study
- Who is it for?
- Ages 18 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atrophic Vaginitis, Vaginal Diseases
- What is being tested?
- Health care product (intimate gel)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Apr 2021to 15 Jul 2021
- 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 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Health volunteers
- Non-injured mucosa in the test region;
- Agreement to comply with safety guidelines to minimize the risk of contamination to COVID-19;
- Agreement to perform molecular testing to detect COVID-19 to enter the study;
- Agreement to adhere to study procedures and requirements and attend the institute on the day(s) and time(s) determined for the evaluations;
- Ability to consent to their participation in the study;
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- Age from 18 to 59 years old (25 participants from 18 to 39 years old, 25 participants from 40 to premenopause and 25 participants in climacteria);
- Female participants;
- Vaginal dryness (slight minimum) - according to questions from the gynecologist.
Who cannot join
- Participants who belong to the risk group for COVID-19, that is, aged over 60 years, with diabetes, with chronic cardiovascular, renal and respiratory problems, immunosuppressed or other conditions that the physician deems to belong to the risk group;
- Participants who have COVID-19, or who have symptoms indicative of the disease in the last 14 days, such as temperature above 36.8°C, fever, cough, shortness of breath, loss of smell, loss of taste and fatigue;
- Pregnancy or breastfeeding;
- Skin pathology in the area of application of the product;
- Diabetes Mellitus type 1; insulin-dependent diabetes; presence of complications due to diabetes (retinopathy, nephropathy, neuropathy); presence of diabetes-related dermatoses (plantar ulcer, lipoid necrobiosis, annular granuloma, opportunistic infections); history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma;
- Current use of the following medications for topical or systemic use: corticosteroids, immunosuppressants and antihistamines;
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- Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis;
- History of reaction to the category of the tested product;
- Other diseases or medications that may directly interfere with the study or endanger the health of the research participant.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Allergisa Pesquisa Dermato-Cosmética Ltda
Campinas, São Paulo, 13084-791
About this study
Official title: Evaluation of Cutaneous Acceptability and Genital Mucosa Acceptability of a Health Care Product (Intimate Gel), and Interference of Microbiota and pH Around the Vaginal Introit, With Instrumental Evaluation of the Mucosa Hydratation
The research will be conducted with a product for use in the intimate region in up to 75 research participants who will use the investigational product for 28 ± 2 days. Will be evaluated and followed up throughout the study by a gynecologist to verify the safety and effectiveness of the product and possible adverse events.
The study will evaluate the non-interference of a topical use product on the intimate area, helping to preserve the natural defenses. In addition, the epithelial hydration and pH of the intimate area will be evaluated.
Read the detailed description
74 female participants, 18 to 59 years of age, healthy with complaints of vaginal dryness. The subjects will be submitted to gynecological evaluation in which pH measurements, hydration measurements and bacterioscopic collection will be performed. Then they will be guided to answer the questionnaires of Perceived Efficacy and Quality of Sexual Life. Next, participants will receive the product for home use, under real conditions of use, for 28 ± 2 days. After 28 ± 2 days of use, subjects will return to the institute, and undergo further evaluations with the gynecologist. New pH measurements, hydration measurements (chronometry), bacterioscopic collection will be performed and the participants will answer the Perceived Efficacy and Quality of Sexual Life questionnaires.
- Conditions
- Atrophic Vaginitis, Vaginal Diseases
- Being tested
- Health care product (intimate gel)
- Medical subject headings
- Atrophic Vaginitis, Vaginal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health care product (intimate gel)Other
heath care product (intimate gel) for home use, under real conditions of use, for 28 ± 2 days
| Study group | Role | What they receive |
|---|---|---|
| female subjects, 18-59 y, healthy | Experimental | 74 female subjects, 18 to 59 years of age, healthy with complaints of vaginal dryness that will receive the heath care product (intimate gel) for home use, under real conditions of use, for 28 ± 2 days. Receives: Other: Health care product (intimate gel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Hydration
Evaluate the perceived hydration through a subjective questionnaire
Measured: 28 ± 2 days
Hydration (device)
Evaluate the hydration, through a hydration measurements by chronometry.
Measured: 28 ± 2 days
Secondary outcomes (2)
Natural defenses preservation (pH)
pH measurements
Measured: 28 ± 2 days
Natural defenses preservation (microbiota)
bacterioscopic collection
Measured: 28 ± 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start9 Apr 2021
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic VaginitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical trial, single-arm
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herbarium Laboratorio Botanico Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247022
- Sponsor's protocol ID
- All-SE-ES-074832
- Status last verified
- Jul 2021
- First submitted
- 27 Jan 2020
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cutaneous Acceptability and Genital Mucosa Acceptability of a Health Care Product (Intimate Gel), and Interference of Microbiota and pH Around the Vaginal Introit, With Instrumental Evaluation of the Mucosa Hydratation
- ClinicalTrials.gov ID
- NCT04247022
- Acronym / sponsor ID
- All-SE-ES-074832
- Conditions
- Atrophic Vaginitis, Vaginal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Herbarium Laboratorio Botanico LtdaIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 29 Jan 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 research will be conducted with a product for use in the intimate region in up to 75 research participants who will use the investigational product for 28 ± 2 days. Will be evaluated and followed up throughout the study by a gynecologist to verify the safety and effectiveness of the product and possible adverse events.
The study will evaluate the non-interference of a topical use product on the intimate area, helping to preserve the natural defenses. In addition, the epithelial hydration and pH of the intimate area will be evaluated.
Detailed description
74 female participants, 18 to 59 years of age, healthy with complaints of vaginal dryness. The subjects will be submitted to gynecological evaluation in which pH measurements, hydration measurements and bacterioscopic collection will be performed. Then they will be guided to answer the questionnaires of Perceived Efficacy and Quality of Sexual Life. Next, participants will receive the product for home use, under real conditions of use, for 28 ± 2 days. After 28 ± 2 days of use, subjects will return to the institute, and undergo further evaluations with the gynecologist. New pH measurements, hydration measurements (chronometry), bacterioscopic collection will be performed and the participants will answer the Perceived Efficacy and Quality of Sexual Life questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical trial, single-arm
| Arm | Type | Receives |
|---|---|---|
| female subjects, 18-59 y, healthy | Experimental | Other: Health care product (intimate gel)74 female subjects, 18 to 59 years of age, healthy with complaints of vaginal dryness that will receive the heath care product (intimate gel) for home use, under real conditions of use, for 28 ± 2 days. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Health volunteers
- Non-injured mucosa in the test region;
- Agreement to comply with safety guidelines to minimize the risk of contamination to COVID-19;
- Agreement to perform molecular testing to detect COVID-19 to enter the study;
- Agreement to adhere to study procedures and requirements and attend the institute on the day(s) and time(s) determined for the evaluations;
Key exclusion criteria (9 listed)
- Participants who belong to the risk group for COVID-19, that is, aged over 60 years, with diabetes, with chronic cardiovascular, renal and respiratory problems, immunosuppressed or other conditions that the physician deems to belong to the risk group;
- Participants who have COVID-19, or who have symptoms indicative of the disease in the last 14 days, such as temperature above 36.8°C, fever, cough, shortness of breath, loss of smell, loss of taste and fatigue;
- Pregnancy or breastfeeding;
- Skin pathology in the area of application of the product;
- Diabetes Mellitus type 1; insulin-dependent diabetes; presence of complications due to diabetes (retinopathy, nephropathy, neuropathy); presence of diabetes-related dermatoses (plantar ulcer, lipoid necrobiosis, annular granuloma, opportunistic infections); history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma;
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 |
|---|---|---|
| Health care product (intimate gel)heath care product (intimate gel) for home use, under real conditions of use, for 28 ± 2 days | Other | female subjects, 18-59 y, healthy |
Primary outcome
Perceived Hydration
Time frame: 28 ± 2 days
Evaluate the perceived hydration through a subjective questionnaire
Hydration (device)
Time frame: 28 ± 2 days
Evaluate the hydration, through a hydration measurements by chronometry.
2 secondary outcomes
Natural defenses preservation (pH)
Time frame: 28 ± 2 days
Natural defenses preservation (microbiota)
Time frame: 28 ± 2 days
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 2 Aug 2021.
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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 Health care product (intimate gel) in people with Atrophic Vaginitis and Vaginal Diseases, run by Herbarium Laboratorio Botanico 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 9 inclusion and 9 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 2 Aug 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?
Perceived Hydration (time frame: 28 ± 2 days). 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 2 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.