Edema, Erythema
Conditions
Brief summary
To evaluate the safety of Miami w/ frag Personal lubricant when used as indicated as a personal lubricant in the vagina and vulvar/perineal areas at least four times weekly for two weeks in a population of healthy females.
Interventions
DEVICEMiami w/ frag Personal lubricant
Sponsors
Church & Dwight Company, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is female between the ages of 18 and 49 years (at lease 21 subjects) or 50-60 years (no more than 9 subjects); * Subject is using adequate non-barrier method of birth control \[established us of hormonal methods of contraception (oral, injected, implanted, or patch), intrauterine device (IUD) or intrauterine system (IUS), surgical sterilization (e.g. in a monogamous relationship with male partner with vasectomy\]; * Subject is free of any vaginal disorders; * Subject is 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 (at least 50% and up to 100% of the study population) or is not sexually active (no more than 50% of the population); * Subject is a personal lubricant user and agrees to replace her usual personal lubricant with the investigational product; * Subject has normal menstrual cycle and is not expected to menstruate 2-4 days before or after the examination days; * Subject agrees to use the provided investigational product at least four times weekly (including at least twice weekly during sexual intercourse for subjects with monogamous, male partners) over the two-week study period; * Subject 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 examination; * Subject is willing to refrain from introducing any new vaginal products, or using vaginal medication or local contraceptives (including condoms and hormonal rings), during the course of this study; * Subject agrees to refrain from douching or using any medications, powder, lotions or personal care products in the vulvar or perianal area for the duration of the study (Note: subjects may continue to use their usual pantyliner, if any); * Subject is willing to use a urine pregnancy test provided to them at baseline and on the third visit (Week 2, day 14); * Subject has a standard Clinical Research Laboratories, Inc. (CRL) Medical History form on file at CRL and has completed study specific Medical History and Screener/Inclusion forms; * Subject has signed and, if sexually active and in a monogamous relationship, whose partner has signed, an Informed Consent Form (ICF) in compliance with 21 CFR Part 50: Protection of Human Subjects; * Subject (and male partner, if applicable) has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164; * Subject is dependable and able to follow directions as outlined in the protocol; * Subject 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
* Subject is pregnant, nursing, or planning a pregnancy; * Subject is post-menopausal or has had a hysterectomy; * Subject is currently using, or has used within two weeks prior to study initiation, any systemic or topical corticosteroids, vasoconstrictors, antibiotics, anti-inflammatories, or antihistamines; * Subject has known allergies to vaginal or any cosmetic products (including lotions, moisturizer, powder, sprays, etc.); * Subject reports a history of recurrent bladder, vaginal infection, or incontinence; * Subject exhibits or reports gynecological abnormalities or has had vaginitis within 60 days prior to study initiation. * Subject is expected to menstruate 2-4 days before or after the time of the first, second, and third examination; * Subject uses a vaginal ring, diaphragm or cervical/vault caps, condoms, or condoms with spermicide as a means of contraception; * Subject has participated in a study involving the vaginal area or in an investigational systemic drug study within two weeks of study initiation; * Subject receives a score higher than 0.5 for erythema, edema, or \>0 for burning, stinging, or itching, during the first examination or shows any other sign of mucosal irregularities (dryness, papules, vesticulation, fissure).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Observed Local Erythema | 14 Days | Number of participants with observed erythema by OB/GYN examination. |
| Number of Participants With Observed Local Edema | 14 Days | Number of participants with observed edema by OB/GYN examination. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Novel Lubricant Miami w/ Frag Personal Lubricant Healthy subjects use Novel lubricant Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Novel Lubricant Miami w/ Frag Personal Lubricant |
|---|---|
| Age, Customized 24-59 | 30 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 Participants With Observed Local Edema
Number of participants with observed edema by OB/GYN examination.
Time frame: 14 Days
Population: female only
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Miami w/ Frag Personal Lubricant | Number of Participants With Observed Local Edema | 0 participants |
Primary
Number of Participants With Observed Local Erythema
Number of participants with observed erythema by OB/GYN examination.
Time frame: 14 Days
Population: female only
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Miami w/ Frag Personal Lubricant | Number of Participants With Observed Local Erythema | 0 participants |