A Study of the Safety and Acceptability of a Placebo Vaginal Film: FAME101

You may not qualify if:

• Menopause (as defined as amenorrhea for one year or more without an alternative etiology)
• Hysterectomy
• Participant report of any of the following:
• Known adverse reaction to any of the study products (ever)
• Known adverse reaction to latex (ever)
• Non- therapeutic injection drug use in the 12 months prior to Screening
• Surgical procedure involving the pelvis in the 90 days prior to enrollment (includes dilation and curettage or evacuation, and cryosurgery; does not include cervical biopsy for evaluation of an abnormal pap smear)
• Participation in a drug, spermicide and/or microbicide study in the 30 days prior to enrollment or anticipated participation in an investigational drug study until completion of the study
• Currently pregnant or pregnancy within 42 days prior to enrollment
• Currently lactating
• Use of a diaphragm, NuvaRing®, or spermicide for contraception
• Internal vaginal use of any device or product (except tampons) in the 48 hours prior to enrollment
• Urogenital infection or suspected infection within 14 days of enrollment including: symptomatic candidiasis, trichomonas vaginalis, and symptomatic bacterial vaginosis; or cervical infection, including N. gonorrhoeae, C. trachomatis, or mucopurulent cervicitis; syphilis; herpes simplex virus lesions, or other sores (Note: seropositive Herpes simplex virus without active lesions will not be excluded); acute pelvic inflammatory disease; urinary tract infection; recent exposure to a partner with N. gonorrhoeae, C. trachomatis, Trichomonas, syphilis, or nongonococcal urethritis.
• Antibiotic or antifungal therapy (vaginal or systemic) within 7 days of enrollment
• As determined by the PI, has any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease
• +2 more criteria