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

Primary Purpose

Erythema, Edema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trojan "Simply Pleasure" Personal Lubricant
Sponsored by
Church & Dwight Company, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Erythema

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Research Laboratories, LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy subject

Arm Description

Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
March 22, 2016
Last Updated
March 20, 2017
Sponsor
Church & Dwight Company, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02737592
Brief Title
A Clinical Study to Evaluate the Safety of a Personal Lubricant in Healthy Female Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Church & Dwight Company, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema, Edema

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy subject
Arm Type
Experimental
Arm Description
Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks
Intervention Type
Device
Intervention Name(s)
Trojan "Simply Pleasure" Personal Lubricant
Intervention Description
silicone base without sensate
Primary Outcome Measure Information:
Title
Number of Subjects With Observed Local Erythema Based on 5 Point Scale
Description
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
Time Frame
2 weeks
Title
Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale
Description
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
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Clinical Research Laboratories, LLC
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States

12. IPD Sharing Statement

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

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