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

This is an interventional screening trial for Erythema Read More

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).