A Clinical Study to Evaluate the Safety of a Personal Lubricant in Healthy Female Subjects

Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02737592
• Other study ID #: ST-7610
• Status: Completed
• Phase: N/A
• First received: March 22, 2016
• Last updated: July 25, 2016
• Start date: March 2016
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: Church & Dwight Company, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Edema
• Erythema

Intervention

Device:
• Trojan "Simply Pleasure" Personal Lubricant
silicone base without sensate

Locations

Country	Name	City	State
United States	Clinical Research Laboratories, LLC	Piscataway	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Church & Dwight Company, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects that showed no erythema based on the 5 point scoring scale		2 weeks	Yes
Primary	Number of subjects that showed no edema based on the 5 point scoring scale		2 weeks	Yes