- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04370548
DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)
A Phase 3 Multi-Center, Double-Blind, Placebo-Controlled, Randomized Study of DARE-BV1 in the Treatment of Bacterial Vaginosis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85712
- Vision Clinical Research-Tuscon
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Colorado
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Denver, Colorado, United States, 80209
- Downtown Women's Health Care
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Florida
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Miami, Florida, United States, 33186
- New Age Medical Research Corporation
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Sunrise, Florida, United States, 33351
- Precision Clinical Research, LLC
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West Palm Beach, Florida, United States, 33409
- Comprehensive Clinical Trials, Llc
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Georgia
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Lawrenceville, Georgia, United States, 30044
- NuDirections Clinical Research, Inc.
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New Jersey
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Lawrenceville, New Jersey, United States, 08648
- Capital Health-Lawrence OB/GYN
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Lawrenceville, New Jersey, United States, 08684
- The Center for Women's Health & Wellness, LLC
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Tennessee
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Jackson, Tennessee, United States, 38305
- The Jackson Clinic, PA
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Virginia
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Norfolk, Virginia, United States, 23507
- Eastern Virginia Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Participants must have a clinical diagnosis of bacterial vaginosis, defined as having all of the following:
- Off-white (milky or gray), thin, homogeneous discharge with minimal or absent pruritus and inflammation of the vulva and vagina
- The presence of clue cells > 20% of the total epithelial cells on microscopic examination of the saline wet mount
- Vaginal secretion pH of > 4.5
- A fishy odor of the vaginal discharge with the addition of a drop of 10% KOH (i.e., a positive "whiff test")
- Participants must be females ≥ 12 years of age with no known medical conditions that, in the Investigator's opinion, may interfere with study participation.
- 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).
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:
- Postmenopausal for at least one year prior to the Entry Visit (Visit 1) (defined as amenorrheic for more than one continuous year), or
- Surgically sterile (defined as bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) at least 6 months before first dose, or
- Non-surgical permanent sterilization procedure at least 3 months prior to first dose.
- 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.
- Participants must be able to read, write, and understand English.
Exclusion Criteria:
- 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.).
- 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.
- Patients with a vaginal, vulvar, or genitourinary condition that, according to the Investigator's judgement, may confound the interpretation of clinical response.
- Patients with a history of regional enteritis, ulcerative colitis, or a history of C. difficile associated diarrhea.
- Patients with known current drug or alcohol abuse that could impact study compliance.
- Patients currently receiving or who have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days of the Screening/Randomization visit.
- Patients who have used any other investigational product within 30 days of the screening/randomization visit.
- 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.
- Patients with known sensitivity to clindamycin phosphate or other lincosamides or any of the inactive ingredients in the study drug.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Clindamycin phosphate vaginal gel, 2%
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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.
Other Names:
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Placebo Comparator: Placebo vaginal gel (Universal HEC Placebo Gel)
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Clinical Cure at the TOC Visit (Day 21-30).
Time Frame: Visit 3 Day 21-30 post randomization
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Clinical cure is defined as:
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Visit 3 Day 21-30 post randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Clinical Cure at the Interim Assessment Visit (Day 7-14).
Time Frame: Visit 2 Day 7-14 post randomization
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Visit 2 Day 7-14 post randomization
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Number of Patients With Bacteriological Cure at the TOC Visit (Day 21-30).
Time Frame: Visit 3 Day 21-30 post randomization
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Bacteriological cure is defined as a Nugent score < 4
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Visit 3 Day 21-30 post randomization
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Number of Patients With Bacteriological Cure at Interim Assessment Visit, Day 7-14
Time Frame: Visit 2, Days 7-14 post randomization
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Visit 2, Days 7-14 post randomization
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Number of Patients With Therapeutic Cure at the TOC Visit (Day 21-30).
Time Frame: Visit 3 Day 21-30 post randomization
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Visit 3 Day 21-30 post randomization
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Number of Patients With Therapeutic Cure at the Interim Assessment Visit (Day 7-14).
Time Frame: Visit 2 Day 7-14 post randomization
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Visit 2 Day 7-14 post randomization
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Patients With Clinical Cure at the Test of Cure Visit (21-30)
Time Frame: Visit 3, Days 21-30 post randomization
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Visit 3, Days 21-30 post randomization
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Number of Patients With Clinical Cure at Interim Assessment Visit, Days 7-14, PP Population
Time Frame: Visit 2, Days 7-14 post randomization
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Visit 2, Days 7-14 post randomization
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Number of Patients With Bacteriological Cure at Test of Cure Visit, Days 21-30, PP Population
Time Frame: Visit 3, Days 21-30 post randomization
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Visit 3, Days 21-30 post randomization
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Number of Patients With Bacteriological Cure, Interim Assessment Visit, Days 7-14, PP Population
Time Frame: Visit 2, Days 7-14 post randomization
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Visit 2, Days 7-14 post randomization
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Number of Patients With Therapeutic Cure at Test of Cure Visit, Days 21-30; PP Population
Time Frame: Visit 3, Days 21-30 post randomization
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Visit 3, Days 21-30 post randomization
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Number of Patients With Therapeutic Cure, Interim Assessment Visit, Days 7-14, PP Population
Time Frame: Visit 2, Days 7-14 post randomization
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Visit 2, Days 7-14 post randomization
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Vaginitis
- Vaginal Diseases
- Vaginosis, Bacterial
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Clindamycin
- Clindamycin palmitate
- Clindamycin phosphate
Other Study ID Numbers
- DARE-BV1-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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