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

NCT ID: NCT02737592

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-04-30

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.

Conditions

Erythema; Edema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Healthy subject

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

Group Type: EXPERIMENTAL

Trojan "Simply Pleasure" Personal Lubricant

Intervention Type: DEVICE

silicone base without sensate

Interventions

Trojan "Simply Pleasure" Personal Lubricant

silicone base without sensate

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Church & Dwight Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Research Laboratories, LLC

Piscataway, New Jersey, United States

Countries

United States

Other Identifiers

ST-7610

Identifier Type: -

Identifier Source: org_study_id