A Single-Center, Clinical Study to Evaluate the Safety of a New Personal Lubricant in Healthy Female Subjects
Study Details
Study Description
Brief 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Healthy subject Healthy subject exposed to Trojan "Chameleon" Personal Lubricant at least four times weekly for two weeks |
Device: Trojan "Chameleon" Personal Lubricant
silicone base with sensate
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects With Observed Local Erythema Based on the 5 Point Scoring Scale [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 [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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
-
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.
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Research Laboratories, LLC | Piscataway | New Jersey | United States | 08854 |
Sponsors and Collaborators
- Church & Dwight Company, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ST-7609
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Healthy Subject |
|---|---|
| Arm/Group Description | Healthy subject exposed to Trojan "Chameleon" Personal Lubricant at least four times weekly for two weeks Trojan "Chameleon" Personal Lubricant: silicone base with sensate |
| Period Title: Overall Study | |
| STARTED | 32 |
| COMPLETED | 30 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Healthy Subject |
|---|---|
| Arm/Group Description | Healthy subject exposed to Trojan "Chameleon" Personal Lubricant at least four times weekly for two weeks Trojan "Chameleon" Personal Lubricant: silicone base with sensate |
| Overall Participants | 30 |
| Age, Customized (Count of Participants) | |
| Age 19-59 |
30
100%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
30
100%
|
| Male |
0
0%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
Outcome Measures
| Title | Number of Subjects With Observed Local Erythema Based on the 5 Point Scoring Scale |
|---|---|
| Description | 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 |
| Time Frame | 2 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Healthy Subject |
|---|---|
| Arm/Group Description | Healthy subject exposed to Trojan "Chameleon" Personal Lubricant at least four times weekly for two weeks Trojan "Chameleon" Personal Lubricant: silicone base with sensate |
| Measure Participants | 30 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale |
|---|---|
| Description | 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 |
| Time Frame | 2 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Healthy Subject |
|---|---|
| Arm/Group Description | Healthy subject exposed to Trojan "Chameleon" Personal Lubricant at least four times weekly for two weeks Trojan "Chameleon" Personal Lubricant: silicone base with sensate |
| Measure Participants | 30 |
| Count of Participants [Participants] |
0
0%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Healthy Subject | |
| Arm/Group Description | Healthy subject exposed to Trojan "Chameleon" Personal Lubricant at least four times weekly for two weeks Trojan "Chameleon" Personal Lubricant: silicone base with sensate | |
All Cause Mortality |
||
| Healthy Subject | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Healthy Subject | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Healthy Subject | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Master service agreement and confidentiality agreement in place
Results Point of Contact
| Name/Title | Annahita Ghassemi |
|---|---|
| Organization | Church & Dwight Co., Inc |
| Phone | 6098061200 |
| annhita.ghassemi@churchdwight.com |
- ST-7609