Edema, Erythema
Conditions
Brief summary
To evaluate the safety of a 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
DEVICETrojan Simply Pleasure Personal Lubricant
silicone base without sensate
Sponsors
Church & Dwight Company, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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 is using adequate non-barrier method of birth control * free from any vaginal disorders * sexually active and in a 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 time 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 5 Point Scale | 2 weeks | Number of subjects with observed local erythema by OB/GYN 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 OB/GYN 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 Simply Pleasures Personal Lubricant at least four times weekly for two weeks
Trojan Simply Pleasure Personal Lubricant: silicone base without sensate | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Healthy Subject |
|---|---|
| Age, Customized Age 20 - 60 | 33 Participants |
| Sex: Female, Male Female | 33 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 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale
Number of subjects with observed local edema by OB/GYN 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 5 Point Scale
Number of subjects with observed local erythema by OB/GYN 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 5 Point Scale | 0 Participants |