Clinical trial NCT02737592: A Clinical Study to Evaluate the Safety of a 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: 34
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 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 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

Primary outcomes:
measure: Number of Subjects With Observed Local Erythema Based on 5 Point 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: