Atrophic VaginitisNCT04327947
Evaluation of Gynecological Acceptability of 3 Health Care Products
A study testing Hyaluronic acid - Research product 1, Hyaluronic acid - Research product 2 and Hyaluronic acid - Comparator product in people with Atrophic Vaginitis and Vaginal Disease, run by Herbarium Laboratorio Botanico Ltda at 1 site in Brazil.
Trial summary
The research was conduct with 3 different products for use in the intimate region in up to 70 research participants, that use the investigational product by 35 ± 2 days. The subjects were follow up throughout the study by a gynecologist for verification of safety, effectiveness and possible adverse events. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atrophic Vaginitis, Vaginal Disease
- What is being tested?
- Hyaluronic acid - Research product 1, Hyaluronic acid - Research product 2 and Hyaluronic acid - Comparator product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Nov 2019to 21 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 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health volunteers
- Non-injured mucosa in the test region;
- 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;
- Age from 18 to 70 years old;
- Female participants;
- Vaginal dryness (slight minimum) - according to questions from the gynecologist.
Who cannot join
- 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;
- 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.
About this study
Official title: Evaluation of Gynecological Acceptability of 3 Health Care Products (Intimate Gel)
The research was conduct with 3 different products for use in the intimate region in up to 70 research participants, that use the investigational product by 35 ± 2 days. The subjects were follow up throughout the study by a gynecologist for verification of safety, effectiveness and possible adverse events.
Read the detailed description
At this study, 70 female participants, 18 to 70 years, healthy with complaints of vaginal dryness used the 3 investigational product, each one by 9 days. Between the changes of product use, there were 4 days of wash out. At the 9th day, the participants answered assessment questionnaire.
- Conditions
- Atrophic Vaginitis, Vaginal Disease
- Being tested
- Hyaluronic acid - Research product 1, Hyaluronic acid - Research product 2, Hyaluronic acid - Comparator product
- 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.
Hyaluronic acid - Research product 1Other
Health care product (intimate gel)
Hyaluronic acid - Research product 2Other
Health care product (intimate gel)
Hyaluronic acid - Comparator productOther
Health care product (intimate gel)
| Study group | Role | What they receive |
|---|---|---|
| women, 18-39 y | Experimental | Health volunteers, 18-39 y, with vaginal dryness Receives: Other: Hyaluronic acid - Research product 1; Other: Hyaluronic acid - Research product 2; Other: Hyaluronic acid - Comparator product |
| premenopause women | Experimental | Health volunteers, 40 years to premenopause, with vaginal dryness Receives: Other: Hyaluronic acid - Research product 1; Other: Hyaluronic acid - Research product 2; Other: Hyaluronic acid - Comparator product |
| climacteric women | Active comparator | Health volunteers, climacteric, with vaginal dryness Receives: Other: Hyaluronic acid - Research product 1; Other: Hyaluronic acid - Research product 2; Other: Hyaluronic acid - Comparator product |
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 based on "Standard Guide for Sensory Claim Substantiation"
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start6 Nov 2019
- Primary completion10 Dec 2019
- Study completion21 Feb 2020
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trial, triple arm, randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 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
- NCT04327947
- Sponsor's protocol ID
- All-S-EP-076888
- Status last verified
- Apr 2020
- First submitted
- 26 Mar 2020
- Last updated
- 3 Apr 2020
- 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 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gynecological Acceptability of 3 Health Care Products (Intimate Gel)
- ClinicalTrials.gov ID
- NCT04327947
- Acronym / sponsor ID
- All-S-EP-076888
- Conditions
- Atrophic Vaginitis, Vaginal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Herbarium Laboratorio Botanico LtdaIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 31 Mar 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 was conduct with 3 different products for use in the intimate region in up to 70 research participants, that use the investigational product by 35 ± 2 days. The subjects were follow up throughout the study by a gynecologist for verification of safety, effectiveness and possible adverse events.
Detailed description
At this study, 70 female participants, 18 to 70 years, healthy with complaints of vaginal dryness used the 3 investigational product, each one by 9 days. Between the changes of product use, there were 4 days of wash out. At the 9th day, the participants answered assessment questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Clinical trial, triple arm, randomized
| Arm | Type | Receives |
|---|---|---|
| women, 18-39 y | Experimental | Other: Hyaluronic acid - Research product 1, Other: Hyaluronic acid - Research product 2, Other: Hyaluronic acid - Comparator productHealth volunteers, 18-39 y, with vaginal dryness |
| premenopause women | Experimental | Other: Hyaluronic acid - Research product 1, Other: Hyaluronic acid - Research product 2, Other: Hyaluronic acid - Comparator productHealth volunteers, 40 years to premenopause, with vaginal dryness |
| climacteric women | Active comparator | Other: Hyaluronic acid - Research product 1, Other: Hyaluronic acid - Research product 2, Other: Hyaluronic acid - Comparator productHealth volunteers, climacteric, with vaginal dryness |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Health volunteers
- Non-injured mucosa in the test region;
- 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;
- Age from 18 to 70 years old;
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| Hyaluronic acid - Research product 1Health care product (intimate gel) | Other | climacteric women, premenopause women, women, 18-39 y |
| Hyaluronic acid - Research product 2Health care product (intimate gel) | Other | climacteric women, premenopause women, women, 18-39 y |
| Hyaluronic acid - Comparator productHealth care product (intimate gel) | Other | climacteric women, premenopause women, women, 18-39 y |
Primary outcome
Perceived hydration
Time frame: 9 days
Evaluate the perceived hydration, through a subjective questionnaire based on "Standard Guide for Sensory Claim Substantiation"
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 3 Apr 2020.
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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 Hyaluronic acid - Research product 1, Hyaluronic acid - Research product 2 and Hyaluronic acid - Comparator product in people with Atrophic Vaginitis and Vaginal Disease, 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 7 inclusion and 8 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 3 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?
Perceived hydration (time frame: 9 days). 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 3 Apr 2020.