DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)

Inclusion Criteria:

1. Participants must provide written informed consent prior to any study-relatedprocedures being performed. Patients from 12 through 17 years old may participatewhere permitted by applicable local regulations and Institutional Review Board (IRB)approval and with appropriate documentation of consent from the parent(s)/guardian(s)and assent from the patient.
2. Participants must have a clinical diagnosis of bacterial vaginosis, defined as havingall of the following:
3. Off-white (milky or gray), thin, homogeneous discharge with minimal or absentpruritus and inflammation of the vulva and vagina
4. The presence of clue cells > 20% of the total epithelial cells on microscopicexamination of the saline wet mount
5. Vaginal secretion pH of > 4.5
6. A fishy odor of the vaginal discharge with the addition of a drop of 10% KOH (i.e., a positive "whiff test")
7. Participants must be females ≥ 12 years of age with no known medical conditions that,in the Investigator's opinion, may interfere with study participation.
8. Participants must agree to abstain from sexual intercourse and/or sexual activitythroughout the first seven days following treatment. Patients must also agree to useadequate birth control (see Inclusion Criterion #5) should they later engage inheterosexual intercourse through the final study visit (Day 21-30).
9. Participants of childbearing potential must have a negative urine pregnancy testresult at screening, should use adequate birth control after the first seven days oftreatment if engaging in heterosexual intercourse, and should not plan on becomingpregnant for the duration of the study. Acceptable forms of birth control include oralcontraceptives (the pill), intrauterine devices (IUDs), contraceptive implants underthe skin, patches or injections, and non-polyurethane condoms (e.g., latex,polyisoprene) with or without spermicide. Patients in monogamous relationships withvasectomized males may also participate. Abstinence may be allowed, but requiresMedical Monitor (or designee) approval prior to randomization. Oral or transdermalhormonal contraceptives must be in use for one full cycle (e.g., four to eight weeks)prior to study drug application. Injectable or implanted contraceptives (e.g.,Depo-Provera, Nexplanon, or hormonal IUD) must be injected/inserted at least sevendays prior to study drug application. Participants who are not of childbearingpotential, as defined below, must also have a negative urine pregnancy test prior torandomization:
10. Postmenopausal for at least one year prior to the Entry Visit (Visit 1) (definedas amenorrheic for more than one continuous year), or
11. Surgically sterile (defined as bilateral tubal ligation, bilateral oophorectomy,or hysterectomy) at least 6 months before first dose, or
12. Non-surgical permanent sterilization procedure at least 3 months prior to first dose.
13. Participants must be willing to refrain from the use of all intra-vaginal products (e.g., douches, feminine deodorant sprays, condoms, spermicides, vaginal moisturizersand lubricants, tampons, vaginal birth control rings [e.g., NuvaRing®], anddiaphragms) through the first 7 days at a minimum, and ideally through Visit 3 (Day 21-30) or Study Exit/Early Discontinuation.
14. Participants must be able to read, write, and understand English.

Exclusion Criteria:

1. Patients with active vulvovaginitis or other active infectious causes of cervicitis,vaginitis, or vulvitis (e.g., candidiasis, Trichomonas vaginalis, Chlamydiatrachomatis, Neisseria gonorrhoeae, or genital lesions or ulcers consistent with humanpapillomavirus, active Herpes simplex, syphilis, chancroid, etc.).
2. Potential participants who are pregnant or breastfeeding, or if of child-bearingpotential unwilling to practice acceptable means of birth control or abstinence duringthe study as described above.
3. Patients with a vaginal, vulvar, or genitourinary condition that, according to theInvestigator's judgement, may confound the interpretation of clinical response.
4. Patients with a history of regional enteritis, ulcerative colitis, or a history of C.difficile associated diarrhea.
5. Patients with known current drug or alcohol abuse that could impact study compliance.
6. Patients currently receiving or who have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days of the Screening/Randomization visit.
7. Patients who have used any other investigational product within 30 days of thescreening/randomization visit.
8. Patients who will undergo evaluation or treatment during the study for abnormalcytology and/or findings from high risk HPV testing and/or Pap test finding.
9. Patients with known sensitivity to clindamycin phosphate or other lincosamides or anyof the inactive ingredients in the study drug.
10. Patients with a history of any severe acute or chronic medical or psychiatriccondition or laboratory abnormality that could increase the risk associated with trialparticipation or study treatment administration or could interfere with theinterpretation of trial results and, in the judgment of the Investigator, would makethe patient inappropriate for entry into the trial.