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

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.

Study Overview

• Status: Completed
• Conditions: Edema; Erythema
• Intervention / Treatment: Device: Trojan "Simply Pleasure" Personal Lubricant

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Piscataway, New Jersey, United States, 08854
      • Clinical Research Laboratories, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: TRIPLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Healthy subject; Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks	Device: Trojan "Simply Pleasure" Personal Lubricant; silicone base without sensate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Observed Local Erythema Based on 5 Point Scale	Number of subjects with observed local erythema by OB/GYN 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	2 weeks
Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale	Number of subjects with observed local edema by OB/GYN 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	2 weeks

Collaborators and Investigators

• Sponsor: Church & Dwight Company, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: March 22, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (ESTIMATE): April 14, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Erythema
• Other Study ID Numbers: ST-7610