Clinical trial NCT02737852: A Single-Center, Clinical Study to Evaluate the Safety of a New Personal Lubricant in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erythema
Edema
Lead sponsor: Church & Dwight Company, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-14
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Number of Subjects With Observed Local Erythema Based on the 5 Point Scoring Scale
timeFrame: 2 weeks
measure: Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Clinical Research Laboratories, LLC
state: New Jersey
Study officials:
References: