ErythemaNCT02737852
A Single-Center, Clinical Study to Evaluate the Safety of a New Personal Lubricant in Healthy Female Subjects
A study testing Trojan "Chameleon" Personal Lubricant in people with Erythema and Edema, run by Church & Dwight Company, Inc. at 1 site in United States.
Trial summary
To evaluate the safety of a new personal lubricant when used at least four times weekly for two weeks (including at least twice weekly during sexual intercourse for subjects with monogamous male partners), in a population consisting of healthy females. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- What is being tested?
- Trojan "Chameleon" Personal Lubricant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- no participation in a similar study 2-weeks prior
- may be post-menopausal or have had a hysterectomy
- if sexually active, and of child bearing potential, subjects using adequate non-barrier method of birth control
- free from any vaginal disorders
- sexually active and monogamous, heterosexual relationship, and whose male partner is willing and able to give informed consent and agrees to engage in sexual intercourse at least twice each week during the two-week study or is not sexually active
- personal lubricant user and agrees to replace her usual personal lubricant with the investigational product
Show all 17Show fewer
- can start regardless of where they are in their cycles
- agrees to use the provided investigational product at least four times weekly over the two week study period
- exhibits no clinically significant evidence of vulvar or vaginal irritation, as determined by a study doctor, and no reports of sensory irritation at the baseline exam
- willing to refrain from introducing any new vaginal products, or using vaginal medications or local contraceptives during study
- agrees to refrain from douching or using any medications, powder, lotions or personal care products in the vulvar or perianal area
- willing to use a urine pregnancy test provided to them at baseline and on third visit
- standard medical history form on file
- signed informed consent
- completed HIPAA
- dependable and able to follow directions as outlined
- receives a score of 0 or 0.5 for erythema and edema: and 0 for sensorial irritation (burning, stinging, itching and dryness) during the first examination.
Who cannot join
- pregnant, nursing or planning a pregnancy
- currently using or has used within two weeks prior to the study initiation, any systemic or topical corticosteroids, vasoconstrictors, antibiotics, anti-inflammatories or antihistamines
- known allergies to vaginal or any cosmetic products
- reports history of recurrent bladder, vaginal infections or incontinence
- exhibits or reports gynecologic abnormalities or has had vaginitis within 60 days prior to study initiation
- uses a vaginal ring, diaphram or cervical/vault caps, condoms, or condoms with spermicide as a means of contraception
- participated in a study involving the vaginal area or in an investigational systemic drug study within two weeks of study initiation
- receives a score higher than 0/5 for erythema, edema or >0 for burning, stinging, or itching, during first examination or shows any other sign of mucosal irregularities
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Laboratories, LLC
Piscataway, New Jersey, 08854
About this study
To evaluate the safety of a new personal lubricant when used at least four times weekly for two weeks (including at least twice weekly during sexual intercourse for subjects with monogamous male partners), in a population consisting of healthy females.
- Being tested
- Trojan "Chameleon" Personal Lubricant
- Medical subject headings
- Erythema, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trojan "Chameleon" Personal LubricantDevice
silicone base with sensate
| Study group | Role | What they receive |
|---|---|---|
| Healthy subject | Experimental | Healthy subject exposed to Trojan "Chameleon" Personal Lubricant at least four times weekly for two weeks Receives: Device: Trojan "Chameleon" Personal Lubricant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Observed Local Erythema Based on the 5 Point Scoring Scale
Number of subjects with observed local erythema by obstetrician/gynecologist examination as graded on 5 point clinical scale: 0 = normal appearance no irritation, 0.5 = slight, irregular erythema, 1 = mild erythema, 2 = moderate erythema 3 = severe erythema
Measured: 2 weeks
Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale
Number of subjects with observed local edema by obstetrician/gynecologist examination as graded on 5 point clinical scale: 0 = normal appearance no edema, 0.5 = slight edema, 1 = mild edema, 2 = moderate edema 3 = severe edema
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ErythemaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737852
- Sponsor's protocol ID
- ST-7609
- Status last verified
- Aug 2017
- First submitted
- 11 Apr 2016
- Last updated
- 1 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Clinical Study to Evaluate the Safety of a New Personal Lubricant in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT02737852
- Acronym / sponsor ID
- ST-7609
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Posted 2 Aug 2017
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 a new personal lubricant when used at least four times weekly for two weeks (including at least twice weekly during sexual intercourse for subjects with monogamous male partners), in a population consisting of healthy females.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subject | Experimental | Device: Trojan "Chameleon" Personal LubricantHealthy subject exposed to Trojan "Chameleon" Personal Lubricant at least four times weekly for two weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- no participation in a similar study 2-weeks prior
- may be post-menopausal or have had a hysterectomy
- if sexually active, and of child bearing potential, subjects using adequate non-barrier method of birth control
- free from any vaginal disorders
- sexually active and monogamous, heterosexual relationship, and whose male partner is willing and able to give informed consent and agrees to engage in sexual intercourse at least twice each week during the two-week study or is not sexually active
Key exclusion criteria (8 listed)
- pregnant, nursing or planning a pregnancy
- currently using or has used within two weeks prior to the study initiation, any systemic or topical corticosteroids, vasoconstrictors, antibiotics, anti-inflammatories or antihistamines
- known allergies to vaginal or any cosmetic products
- reports history of recurrent bladder, vaginal infections or incontinence
- exhibits or reports gynecologic abnormalities or has had vaginitis within 60 days prior to study initiation
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 |
|---|---|---|
| Trojan "Chameleon" Personal Lubricantsilicone base with sensate | Device | Healthy subject |
Primary outcome
Number of Subjects With Observed Local Erythema Based on the 5 Point Scoring Scale
Time frame: 2 weeks
Number of subjects with observed local erythema by obstetrician/gynecologist examination as graded on 5 point clinical scale: 0 = normal appearance no irritation, 0.5 = slight, irregular erythema, 1 = mild erythema, 2 = moderate erythema 3 = severe erythema
Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale
Time frame: 2 weeks
Number of subjects with observed local edema by obstetrician/gynecologist examination as graded on 5 point clinical scale: 0 = normal appearance no edema, 0.5 = slight edema, 1 = mild edema, 2 = moderate edema 3 = severe edema
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Trojan "Chameleon" Personal Lubricant in people with Erythema and Edema, run by Church & Dwight Company, Inc. at 1 site in United States.
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 17 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 1 Sep 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 2 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With Observed Local Erythema Based on the 5 Point Scoring Scale (time frame: 2 weeks). 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 1 Sep 2017.