A Single-Center, Clinical Study to Evaluate the Safety of a Fragranced Personal Lubricant in Healthy Female Subjects

Study Overview
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Brief Summary
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To evaluate the safety of Miami w/ frag Personal lubricant when used as indicated as a personal lubricant in the vagina and vulvar/perineal areas at least four times weekly for two weeks in a population of healthy females.

Conditions
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Erythema, Edema

Intervention / Treatment
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* Device: Miami w/ frag Personal lubricant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is female between the ages of 18 and 49 years (at lease 21 subjects) or 50-60 years (no more than 9 subjects); Subject is using adequate non-barrier method of birth control [established us of hormonal methods of contraception (oral, injected, implanted, or patch), intrauterine device (IUD) or intrauterine system (IUS), surgical sterilization (e.g. in a monogamous relationship with male partner with vasectomy]; Subject is free of any vaginal disorders; Subject is 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 (at least 50% and up to 100% of the study population) or is not sexually active (no more than 50% of the population); Subject is a personal lubricant user and agrees to replace her usual personal lubricant with the investigational product; Subject has normal menstrual cycle and is not expected to menstruate 2-4 days before or after the examination days; Subject agrees to use the provided investigational product at least four times weekly (including at least twice weekly during sexual intercourse for subjects with monogamous, male partners) over the two-week study period; Subject 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 examination; Subject is willing to refrain from introducing any new vaginal products, or using vaginal medication or local contraceptives (including condoms and hormonal rings), during the course of this study; Subject agrees to refrain from douching or using any medications, powder, lotions or personal care products in the vulvar or perianal area for the duration of the study (Note: subjects may continue to use their usual pantyliner, if any); Subject is willing to use a urine pregnancy test provided to them at baseline and on the third visit (Week 2, day 14); Subject has a standard Clinical Research Laboratories, Inc. (CRL) Medical History form on file at CRL and has completed study specific Medical History and Screener/Inclusion forms; Subject has signed and, if sexually active and in a monogamous relationship, whose partner has signed, an Informed Consent Form (ICF) in compliance with 21 CFR Part 50: Protection of Human Subjects; Subject (and male partner, if applicable) has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164; Subject is dependable and able to follow directions as outlined in the protocol; Subject 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: Subject is pregnant, nursing, or planning a pregnancy; Subject is post-menopausal or has had a hysterectomy; Subject is currently using, or has used within two weeks prior to study initiation, any systemic or topical corticosteroids, vasoconstrictors, antibiotics, anti-inflammatories, or antihistamines; Subject has known allergies to vaginal or any cosmetic products (including lotions, moisturizer, powder, sprays, etc.); Subject reports a history of recurrent bladder, vaginal infection, or incontinence; Subject exhibits or reports gynecological abnormalities or has had vaginitis within 60 days prior to study initiation. Subject is expected to menstruate 2-4 days before or after the time of the first, second, and third examination; Subject uses a vaginal ring, diaphragm or cervical/vault caps, condoms, or condoms with spermicide as a means of contraception; Subject has participated in a study involving the vaginal area or in an investigational systemic drug study within two weeks of study initiation; Subject receives a score higher than 0.5 for erythema, edema, or >0 for burning, stinging, or itching, during the first examination or shows any other sign of mucosal irregularities (dryness, papules, vesticulation, fissure).

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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Miami w/ frag Personal lubricant<br>Healthy subjects use Novel lubricant Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks. | Device: Miami w/ frag Personal lubricant<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Observed Local Erythema | Number of participants with observed erythema by OB/GYN examination. | 14 Days | 
| Number of Participants With Observed Local Edema | Number of participants with observed edema by OB/GYN examination. | 14 Days |