Evaluation of Intravaginal Gel and Ovule Formulations of TOL-463

Inclusion Criteria

• •Adult women of any race between 18 to 45 years of age (inclusive).
• •Subjects must be able to give voluntary written informed consent before any study related procedure is performed.
• •Subjects must have a negative serum pregnancy test at Screening and negative urine pregnancy test at all other clinical site visits, as applicable.
• •Subjects either have no childbearing potential (as defined below) (Note 1) or agree to avoid becoming pregnant from the day of screening through one month after the last study Day using one of the following acceptable methods of birth control (Note 2) in addition to the use of non-lubricated condoms by the male partner (even if vasectomized).
• •* Hormonal contraceptives
• •* Abstinence
• •* Note 1: Non-childbearing potential is defined as being post-menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy or status after hysterectomy.
• •* Note 2: Intravaginal or intra-uterine contraceptives and contraceptive devices (IUDs) are not acceptable forms of birth control for this study.
• •Subjects must agree to refrain from douching or using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, etc.) or IUDs during the study period.
• •Subjects must agree not to donate blood during the study and up to 14 days after the end of the study.
• •Subjects willing and able to comply with all study requirements.
• •For Part 1 Only
• •Subjects must be healthy as determined by medical history, physical examination, vital signs, pelvic examination and laboratory evaluations (hematology, clinical chemistry and urinalysis tests) within study-defined ranges at Screening.
• •Subjects must be without current symptomatic or asymptomatic bacterial vaginosis, candida vulvovaginitis or any other form of vaginitis by clinical and microbiologic testing.
• •Subjects must be willing to abstain from sexual intercourse for 24 hours prior to each site visit.
• •For Part 2 Only
• •Subjects with vaginitis must be otherwise healthy based on medical history, physical examination, vital signs, pelvic examination and laboratory evaluations (hematology, clinical chemistry and urinalysis tests) within study-defined ranges at Screening.
• •Subjects with vaginitis must be willing to abstain from sexual intercourse 24 hours prior to the first dose of study medication and throughout the last visit of the study.