Edema, Erythema
Conditions
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.
Interventions
silicone base with sensate
Sponsors
Church & Dwight Company, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
The new personal lubricant was used by all participants
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Subject Healthy subject exposed to Trojan Chameleon Personal Lubricant at least four times weekly for two weeks
Trojan Chameleon Personal Lubricant: silicone base with sensate | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Healthy Subject | — |
|---|---|---|
| Age, Customized Age 19-59 | 30 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 30 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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
Time frame: 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Subject | Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale | 0 Participants |
Primary
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
Time frame: 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Subject | Number of Subjects With Observed Local Erythema Based on the 5 Point Scoring Scale | 0 Participants |