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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04370548
Recruitment Status : Completed
First Posted : May 1, 2020
Results First Posted : July 2, 2021
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
Daré Bioscience, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: DARE-BV1clindamycin phosphate vaginal gel, 2% Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 307 participants
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
Primary Purpose: Treatment
Official Title: A Phase 3 Multi-Center, Double-Blind, Placebo-Controlled, Randomized Study of DARE-BV1 in the Treatment of Bacterial Vaginosis
Actual Study Start Date : June 16, 2020
Actual Primary Completion Date : November 30, 2020
Actual Study Completion Date : December 7, 2020


Arm Intervention/treatment
Experimental: Clindamycin phosphate vaginal gel, 2% Drug: DARE-BV1clindamycin phosphate vaginal gel, 2%
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 Name: Placebo vaginal gel (HEC Universal Placebo Gel)

Placebo Comparator: Placebo vaginal gel (Universal HEC Placebo Gel) Drug: DARE-BV1clindamycin phosphate vaginal gel, 2%
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 Name: Placebo vaginal gel (HEC Universal Placebo Gel)




Primary Outcome Measures :
  1. Clinical Cure [ Time Frame: Visit 3 Day 21-30 post randomization ]

    The primary efficacy endpoint is the proportion of patients with Clinical Cure at the TOC visit (Day 21-30). Clinical cure is defined as:

    • Resolution of the abnormal vaginal discharge associated with BV;
    • Negative 10% KOH "whiff test;" and
    • Clue cells < 20% of the total epithelial cells in the saline wet mount.


Secondary Outcome Measures :
  1. Proportion of Patients With Clinical Cure at the Interim Assessment Visit (Day 7-14). [ Time Frame: Visit 2 Day 7-14 post randomization ]
  2. Proportion of Patients With Bacteriological Cure at the TOC Visit (Day 21-30). Bacteriological Cure is Defined as a Nugent Score < 4 [ Time Frame: Visit 3 Day 21-30 post randomization ]
  3. Proportion of Patients With Bacteriological Cure at Interim Assessment Visit, Day 7-14 [ Time Frame: Visit 2, Days 7-14 post randomization ]
  4. Proportion of Patients With Therapeutic Cure at the TOC Visit (Day 21-30). [ Time Frame: Visit 3 Day 21-30 post randomization ]
  5. Proportion of Patients With Therapeutic Cure at the Interim Assessment Visit (Day 7-14). [ Time Frame: Visit 2 Day 7-14 post randomization ]

Other Outcome Measures:
  1. Proportion of Patients With Clinical Cure at the Test of Cure Visit (21-30) [ Time Frame: Visit 3, Days 21-30 post randomization ]
  2. Proportion of Patients With Clinical Cure at Interim Assessment Visit, Days 7-14, PP Population [ Time Frame: Visit 2, Days 7-14 post randomization ]
  3. Proportion of Patients With Bacteriological Cure at Test of Cure Visit, Days 21-30, PP Population [ Time Frame: Visit 3, Days 21-30 post randomization ]
  4. Proportion of Patients With Bacteriological Cure, Interim Assessment Visit, Days 7-14, PP Population [ Time Frame: Visit 2, Days 7-14 post randomization ]
  5. Proportion of Patients With Therapeutic Cure at Test of Cure Visit, Days 21-30; PP Population [ Time Frame: Visit 3, Days 21-30 post randomization ]
  6. Proportion of Patients With Therapeutic Cure, Interim Assessment Visit, Days 7-14, PP Population [ Time Frame: Visit 2, Days 7-14 post randomization ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04370548


Locations
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United States, Arizona
Vision Clinical Research-Tuscon
Tucson, Arizona, United States, 85712
United States, Colorado
Downtown Women's Health Care
Denver, Colorado, United States, 80209
United States, Florida
New Age Medical Research Corporation
Miami, Florida, United States, 33186
Precision Clinical Research, LLC
Sunrise, Florida, United States, 33351
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States, 33409
United States, Georgia
NuDirections Clinical Research, Inc.
Lawrenceville, Georgia, United States, 30044
United States, New Jersey
Capital Health-Lawrence OB/GYN
Lawrenceville, New Jersey, United States, 08648
The Center for Women's Health & Wellness, LLC
Lawrenceville, New Jersey, United States, 08684
United States, Tennessee
The Jackson Clinic, PA
Jackson, Tennessee, United States, 38305
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Daré Bioscience, Inc.
  Study Documents (Full-Text)

Documents provided by Daré Bioscience, Inc.:
Study Protocol  [PDF] August 14, 2020
Statistical Analysis Plan  [PDF] October 14, 2020

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Responsible Party: Daré Bioscience, Inc.
ClinicalTrials.gov Identifier: NCT04370548    
Other Study ID Numbers: DARE-BV1-001
First Posted: May 1, 2020    Key Record Dates
Results First Posted: July 2, 2021
Last Update Posted: July 2, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Vaginitis
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action