Female Dry Genital MucosaDERM GYN ACCEPNCT03007615
Dermal and Gynecological Acceptability (Irritability and Sensitization in the Genital Mucosa) of an Investigational Product and Evaluation of Moisture Efficacy by TEWL and Perceived Efficacy.
A study testing Intimate Lubricant Gel in people with Female Dry Genital Mucosa, run by Kley Hertz S/A.
Trial summary
To evaluate the safety of an investigational product through the verification of signs of irritability and sensitization of the genital mucosa, as well as the instrumental moisturizing efficacy by TEWL and barrier integrity analysis, in addition to the efficacy perceived by the volunteers. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Dry Genital Mucosa
- What is being tested?
- Intimate Lubricant Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Feb 2017
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female sex with active sex life;
- Age group: between 45 and 65 years old;
- Menopause for at least six months;
- Whole skin in the region of product analysis;
- No history of reaction to products of the same category
- Understanding, agreement and signature of the Term of Free and Informed Consent.
Who cannot join
- Gestation or risk of gestation;
- Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study);
- Active cutaneous pathologies (local and / or disseminated) in the evaluation area;
- Pathologies that cause suppression of immunity, such as diabetes, HIV, etc.;
- Endocrine pathologies such as thyroid disorders, ovarian or adrenal gland disorders;
- Any infection in the region of analysis of the product diagnosed at the time of inclusion;
- Other conditions considered by the investigating physician as reasonable for disqualification of the individual from the study participation.
About this study
To evaluate the safety of an investigational product through the verification of signs of irritability and sensitization of the genital mucosa, as well as the instrumental moisturizing efficacy by TEWL and barrier integrity analysis, in addition to the efficacy perceived by the volunteers.
- Conditions
- Female Dry Genital Mucosa
- Being tested
- Intimate Lubricant Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intimate Lubricant GelOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Other: Intimate Lubricant Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the product's efficiency as a moisturizer through subjective evaluation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Dry Genital MucosaStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kley Hertz S/A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007615
- Sponsor's protocol ID
- Kley Hertz 007
- Acronym
- DERM GYN ACCEP
- Status last verified
- Dec 2016
- First submitted
- 29 Dec 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermal and Gynecological Acceptability (Irritability and Sensitization in the Genital Mucosa) of an Investigational Product and Evaluation of Moisture Efficacy by TEWL and Perceived Efficacy.
- ClinicalTrials.gov ID
- NCT03007615
- Acronym / sponsor ID
- DERM GYN ACCEP / Kley Hertz 007
- Conditions
- Female Dry Genital Mucosa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Kley Hertz S/AIndustry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- Feb 2017 (estimated)
- First posted
- 2 Jan 2017 (estimated)
- 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 safety of an investigational product through the verification of signs of irritability and sensitization of the genital mucosa, as well as the instrumental moisturizing efficacy by TEWL and barrier integrity analysis, in addition to the efficacy perceived by the volunteers.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Intimate Lubricant Gel |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy female sex with active sex life;
- Age group: between 45 and 65 years old;
- Menopause for at least six months;
- Whole skin in the region of product analysis;
- No history of reaction to products of the same category
Key exclusion criteria (7 listed)
- Gestation or risk of gestation;
- Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study);
- Active cutaneous pathologies (local and / or disseminated) in the evaluation area;
- Pathologies that cause suppression of immunity, such as diabetes, HIV, etc.;
- Endocrine pathologies such as thyroid disorders, ovarian or adrenal gland disorders;
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 |
|---|---|---|
| Intimate Lubricant Gel | Other | Experimental group |
Primary outcome
Evaluation of the product's efficiency as a moisturizer through subjective evaluation
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
Related trials for Female Dry Genital Mucosa
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
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 study testing Intimate Lubricant Gel in people with Female Dry Genital Mucosa, run by Kley Hertz 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 6 inclusion and 7 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 2 Jan 2017. 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.
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?
Evaluation of the product's efficiency as a moisturizer through subjective evaluation (time frame: 30 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 2 Jan 2017.