a single-center, clinical study to evaluate the safety of a fragranced personal lubricant in healthy female subjects

Conditions: Erythema; Edema

Summary: 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.


Eligibility criteria:
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).