A Single-Center, Clinical Study to Evaluate the Safety of a New Personal Lubricant in Healthy Female Subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale
Study Overview
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Masking Description
The new personal lubricant was used by all participants
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Healthy subject
Healthy subject exposed to Trojan "Chameleon" Personal Lubricant at least four times weekly for two weeks
Intervention: Trojan "Chameleon" Personal Lubricant (Device)
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
No secondary outcomes reported