DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: DARE-BV1clindamycin phosphate vaginal gel, 2%
Intervention description: One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) or placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible patients will be randomly assigned to one of the following treatment groups (2:1): DARE- BV1 clindamycin phosphate vaginal gel, 2% (1 dose is 5 g gel = 100 mg clindamycin) QD × 1 day, or placebo vaginal gel (Universal HEC Placebo Gel), 5g, QD × 1 day. Study drug will be applied intravaginally within 1 day of randomization.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: double blind
Enrollment: 307.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, double-blind, placebo-controlled study of DARE-BV1
      (clindamycin phosphate vaginal gel, 2%) (QD x 1 day) compared to placebo vaginal gel (HEC
      Universal Placebo Gel) (QD × 1 day) for the treatment of bacterial vaginosis. Patients will
      be evaluated at three time points: a Day 1 Screening/Randomization visit, a Day 7-14 Interim
      Assessment visit, and a Day 21 - 30 Test of Cure [TOC] visit). Patients who discontinue
      prematurely from the study will receive a safety follow-up phone call between Day 21-30. The
      total study duration will be approximately one month for each individual patient.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants must provide written informed consent prior to any study-related
             procedures being performed. Patients from 12 through 17 years old may participate
             where 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 having
             all of the following:

               1. Off-white (milky or gray), thin, homogeneous discharge with minimal or absent
                  pruritus and inflammation of the vulva and vagina

               2. The presence of clue cells > 20% of the total epithelial cells on microscopic
                  examination of the saline wet mount

               3. Vaginal secretion pH of > 4.5

               4. A fishy odor of the vaginal discharge with the addition of a drop of 10% KOH
                  (i.e., a positive "whiff test")

          3. Participants must be females ≥ 12 years of age with no known medical conditions that,
             in the Investigator's opinion, may interfere with study participation.

          4. Participants must agree to abstain from sexual intercourse and/or sexual activity
             throughout the first seven days following treatment. Patients must also agree to use
             adequate birth control (see Inclusion Criterion #5) should they later engage in
             heterosexual intercourse through the final study visit (Day 21-30).

          5. Participants of childbearing potential must have a negative urine pregnancy test
             result at screening, should use adequate birth control after the first seven days of
             treatment if engaging in heterosexual intercourse, and should not plan on becoming
             pregnant for the duration of the study. Acceptable forms of birth control include oral
             contraceptives (the pill), intrauterine devices (IUDs), contraceptive implants under
             the skin, patches or injections, and non-polyurethane condoms (e.g., latex,
             polyisoprene) with or without spermicide. Patients in monogamous relationships with
             vasectomized males may also participate. Abstinence may be allowed, but requires
             Medical Monitor (or designee) approval prior to randomization. Oral or transdermal
             hormonal 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 seven
             days prior to study drug application. Participants who are not of childbearing
             potential, as defined below, must also have a negative urine pregnancy test prior to
             randomization:

               1. Postmenopausal for at least one year prior to the Entry Visit (Visit 1) (defined
                  as amenorrheic for more than one continuous year), or

               2. Surgically sterile (defined as bilateral tubal ligation, bilateral oophorectomy,
                  or hysterectomy) at least 6 months before first dose, or

          6. Non-surgical permanent sterilization procedure at least 3 months prior to first dose.

          7. Participants must be willing to refrain from the use of all intra-vaginal products
             (e.g., douches, feminine deodorant sprays, condoms, spermicides, vaginal moisturizers
             and lubricants, tampons, vaginal birth control rings [e.g., NuvaRing®], and
             diaphragms) through the first 7 days at a minimum, and ideally through Visit 3 (Day
             21-30) or Study Exit/Early Discontinuation.

          8. 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, Chlamydia
             trachomatis, Neisseria gonorrhoeae, or genital lesions or ulcers consistent with human
             papillomavirus, active Herpes simplex, syphilis, chancroid, etc.).

          2. Potential participants who are pregnant or breastfeeding, or if of child-bearing
             potential unwilling to practice acceptable means of birth control or abstinence during
             the study as described above.

          3. Patients with a vaginal, vulvar, or genitourinary condition that, according to the
             Investigator'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 the
             screening/randomization visit.

          8. Patients who will undergo evaluation or treatment during the study for abnormal
             cytology 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 any
             of the inactive ingredients in the study drug.

         10. Patients with a history of any severe acute or chronic medical or psychiatric
             condition or laboratory abnormality that could increase the risk associated with trial
             participation or study treatment administration or could interfere with the
             interpretation of trial results and, in the judgment of the Investigator, would make
             the patient inappropriate for entry into the trial.