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

Study Overview
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Brief Summary
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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
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Erythema, Edema

Intervention / Treatment
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* Device: Trojan Simply Pleasure Personal Lubricant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy subject<br>Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks | Device: Trojan Simply Pleasure Personal Lubricant<br>* silicone base without sensate<br>|

What is the study measuring?
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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 |