Vaginal DrynessPhase 4NCT03782961
Evaluation of Viscosity of a Vaginal Moisturizer
A Phase 4 study testing sodium lactate and combination of polymers in people with Vaginal Dryness and Menopausal Women, run by Farmoquimica S.A..
Trial summary
To evaluate the perception of viscosity of a vaginal moisturizer in postmenopausal women Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Dryness, Menopausal Women
- What is being tested?
- sodium lactate and combination of polymers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 14 Jan 2019to 25 Jan 2019
- Phase
- Phase 4
- 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 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Menopausal participants for at least 6 months;
- Participants with complaints of vaginal dryness;
- Skin integrity in the region of product analysis;
- Agreement to comply the procedures of the trial and attend the clinic on the days and times determined for applications and / or evaluations;
- Understanding, agreement and signing of the Informed Consent Term.
Who cannot join
- Use of anti-inflammatory / immunosuppressive / antihistamine drugs up to 3 weeks prior to selection;
- Pathologies and / or active skin lesions (local and / or disseminated) in the evaluation area;
- Immunosuppression by drugs or active diseases;
- Decompensated endocrinopathies;
- Relevant clinical history or current evidence of alcohol or other drug abuse;
- known history or suspected intolerance to products of the same category;
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- Intense sun exposure up to 15 days before evaluation;
- Gynecological treatment up to 4 weeks before evaluation;
- Other conditions considered by the researcher to be reasonable for disqualification of study participation.
About this study
Official title: Evaluation of Perceived Effectiveness to Evaluate Viscosity of a Vaginal Moisturizer in Menopaused Women
To evaluate the perception of viscosity of a vaginal moisturizer in postmenopausal women
Read the detailed description
A unicentric, blind, non-comparative clinical study to prove the perceived efficacy of the research product.
It will be necessary 33 female research participants, aged between 45 and 70 years menopause with complaint of vaginal dryness.
The participant will remain in the study for one day, making use of the research product in the Research Center.
Participants will be divided into 2 groups so that each group observes the viscosity (flow) of the test product in a different anatomical position (lying down and standing) immediately after application of the product, after 15 and 30 minutes.
Participants will respond to a subjective assessment using a standardized questionnaire to capture possible feelings of discomfort during the study.
A gynecologist will be available to monitor the participants throughout the study.
- Conditions
- Vaginal Dryness, Menopausal Women
- Being tested
- sodium lactate and combination of polymers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium lactate and combination of polymersDevice
sodium lactate and combination of polymers (polycarbophil, carbomer and PVM / MA copolymer)
| Study group | Role | What they receive |
|---|---|---|
| Stand up | Experimental | After application of the product (sodium lactate and combination of polymers) will remain standing for 30 minutes Receives: Device: sodium lactate and combination of polymers |
| Lying down | Experimental | After application of the product (sodium lactate and combination of polymers) remained lying down with the legs stretched for 30 minutes; Receives: Device: sodium lactate and combination of polymers |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate subjectively the perceived viscosity change
Perceived viscosity change of the research product from the point of view of the target public under normal conditions of use through a questionnaire
Measured: Immediately after application, 15 and 30 minutes after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start14 Jan 2019 (estimated)
- Primary completion25 Jan 2019 (estimated)
- Study completion25 Jan 2019 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Farmoquimica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782961
- Sponsor's protocol ID
- FE4 - HIDRAFEMME - PA - 010
- Status last verified
- Dec 2018
- First submitted
- 18 Dec 2018
- Last updated
- 21 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perceived Effectiveness to Evaluate Viscosity of a Vaginal Moisturizer in Menopaused Women
- ClinicalTrials.gov ID
- NCT03782961
- Acronym / sponsor ID
- FE4 - HIDRAFEMME - PA - 010
- Conditions
- Vaginal Dryness, Menopausal Women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Farmoquimica S.A.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2019 (estimated)
- Primary completion
- 25 Jan 2019 (estimated)
- Study completion
- 25 Jan 2019 (estimated)
- First posted
- 20 Dec 2018 (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.
To evaluate the perception of viscosity of a vaginal moisturizer in postmenopausal women
Detailed description
A unicentric, blind, non-comparative clinical study to prove the perceived efficacy of the research product.
It will be necessary 33 female research participants, aged between 45 and 70 years menopause with complaint of vaginal dryness.
The participant will remain in the study for one day, making use of the research product in the Research Center.
Participants will be divided into 2 groups so that each group observes the viscosity (flow) of the test product in a different anatomical position (lying down and standing) immediately after application of the product, after 15 and 30 minutes.
Participants will respond to a subjective assessment using a standardized questionnaire to capture possible feelings of discomfort during the study.
A gynecologist will be available to monitor the participants throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stand up | Experimental | Device: sodium lactate and combination of polymersAfter application of the product (sodium lactate and combination of polymers) will remain standing for 30 minutes |
| Lying down | Experimental | Device: sodium lactate and combination of polymersAfter application of the product (sodium lactate and combination of polymers) remained lying down with the legs stretched for 30 minutes; |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Menopausal participants for at least 6 months;
- Participants with complaints of vaginal dryness;
- Skin integrity in the region of product analysis;
- Agreement to comply the procedures of the trial and attend the clinic on the days and times determined for applications and / or evaluations;
- Understanding, agreement and signing of the Informed Consent Term.
Key exclusion criteria (9 listed)
- Use of anti-inflammatory / immunosuppressive / antihistamine drugs up to 3 weeks prior to selection;
- Pathologies and / or active skin lesions (local and / or disseminated) in the evaluation area;
- Immunosuppression by drugs or active diseases;
- Decompensated endocrinopathies;
- Relevant clinical history or current evidence of alcohol or other drug abuse;
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 |
|---|---|---|
| sodium lactate and combination of polymerssodium lactate and combination of polymers (polycarbophil, carbomer and PVM / MA copolymer) | Device | Lying down, Stand up |
Primary outcome
To evaluate subjectively the perceived viscosity change
Time frame: Immediately after application, 15 and 30 minutes after application
Perceived viscosity change of the research product from the point of view of the target public under normal conditions of use through a questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sodium lactate and combination of polymers in people with Vaginal Dryness and Menopausal Women, run by Farmoquimica S.A..
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 5 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: status not confirmed, as of the sponsor's last update on 21 Dec 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To evaluate subjectively the perceived viscosity change (time frame: Immediately after application, 15 and 30 minutes after application). 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 21 Dec 2018.