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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02737592
Recruitment Status : Completed
First Posted : April 14, 2016
Results First Posted : March 20, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Church & Dwight Company, Inc.

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.

Condition or disease Intervention/treatment Phase
Erythema Edema Device: Trojan "Simply Pleasure" Personal Lubricant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Study Start Date : March 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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




Primary Outcome Measures :
  1. 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. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737592


Locations
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United States, New Jersey
Clinical Research Laboratories, LLC
Piscataway, New Jersey, United States, 08854
Sponsors and Collaborators
Church & Dwight Company, Inc.

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Responsible Party: Church & Dwight Company, Inc.
ClinicalTrials.gov Identifier: NCT02737592     History of Changes
Other Study ID Numbers: ST-7610
First Posted: April 14, 2016    Key Record Dates
Results First Posted: March 20, 2017
Last Update Posted: April 17, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Erythema
Skin Diseases
Skin Manifestations
Signs and Symptoms