Suppression Of Bacterial Vaginosis (BV) [SUBVert]

Inclusion Criteria

Screening Visit(s) Inclusion Criteria:

• Women with a current Bacterial Vaginosis (BV) infection and a history of at least two previous episodes of BV by documentation or self-report in the past year. Screening (V0) diagnosis is based on the presence of > / = 3 Amsel criteria*;
• Homogeneous vaginal discharge; positive potassium hydroxide (KOH) whiff test; vaginal pH of > 4.5; and > / = 20% clue cells.
• Willing and able to provide written informed consent;
• Age 18-55 years of age at the time of V0;
• General good health based on medical history, targeted physical examination, and pelvic examination;
• For participants 21 years of age or older, Pap test performed within the past 3 years, with the most recent result being normal or Atypical Squamous Cells of Undetermined Significance (ASCUS) Human Papillomavirus (HPV) negative or Pap smear collected at V0*;

*Consistent with current Pap screening guidelines, a Pap smear must be performed at V0, for women who meet the following criteria and cannot provide documentation or self-report of a normal or ASCUS HPV negative Pap smear, conducted within the prior 3 years: (a) has not had a hysterectomy or (b) has had a hysterectomy and has a history of cervical intraepithelial neoplasia grade 2 plus (CIN2plus) in the past 20 years.

Note: If a Pap smear is conducted at V0, the results are not required prior to enrollment.

• Have a negative urine pregnancy test at V0, if of childbearing potential;
• Must be of non-childbearing potential* or must be using an effective method of birth control** and must be willing to continue the method through the end of Investigational Product (IP) administration;

*Defined as post-menopausal or status post bilateral tubal ligation, or status post bilateral oophorectomy or status post hysterectomy.

**Acceptable methods are defined as:

• Intrauterine Devices (IUDs) or hormonal contraceptives for at least 22 days prior to screening. Note: Intravaginal contraceptive rings (e.g., NuvaRing) are not acceptable forms of birth control for this study.
• Consistent use of a barrier method, including diaphragms or condoms, for at least 13 days prior to screening.
• Abstinence from vaginal sexual intercourse for at least 13 days prior to screening.
• Exclusively same-sex relationship.
• Monogamous relationship with vasectomized partner.
• Willing and able to cooperate to the extent and degree required by this protocol at the discretion of the investigator;

Enrollment Visit Inclusion Criteria:

In addition to confirming all relevant Screening Visit Inclusion Criteria, women must meet all of the following criteria to be eligible for enrollment in the study.

• Willing and able to provide Enrollment written informed consent;
• After completion of metronidazole induction therapy or another CDC-recommended BV treatment, no clinical evidence of BV* and absence of symptoms of BV** at Visit 1, Enrollment (V1);
• As defined by < / = 2 of 4 Amsel criteria. **Defined as absence of vaginal discharge and odor consistent with BV.
• Must have a negative urine pregnancy test at V1, if of childbearing potential;
• Willing to refrain from any intravaginal products/medications* other than the IP throughout the course of the trial;

*For example: douches, antifungal or antibacterial preparations, lubricants, contraceptive creams, gels, foams, sponges, spermicides.

• Must agree to abstain from receptive oral, anal, and vaginal sexual intercourse one hour prior to IP administration and for 24 hours after;
• Willing to refrain from using tampons or menstrual cups for 24 hours after IP administration;
• Must be of non-childbearing potential* OR must be using an effective method of birth control** and must be willing to continue the method through the end of IP administration; *Defined as post-menopausal or status post bilateral tubal ligation, or status post bilateral oophorectomy or status post hysterectomy.
• Acceptable methods are defined a