- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02737592
A Clinical Study to Evaluate the Safety of a Personal Lubricant in Healthy Female Subjects
March 20, 2017 updated by: Church & Dwight Company, Inc.
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Piscataway, New Jersey, United States, 08854
- Clinical Research Laboratories, LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: TRIPLE
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
|
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
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- ST-7610
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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