Bacterial VaginosisPhase 3NCT04370548
DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)
A Phase 3 study testing DARE-BV1clindamycin phosphate vaginal gel, 2% in people with Bacterial Vaginosis, run by Daré Bioscience, Inc. at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- DARE-BV1clindamycin phosphate vaginal gel, 2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 307 participants
- Where
- 10 sitesUnited States
- Study dates
- 16 Jun 2020to 7 Dec 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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")
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Downtown Women's Health Care
Denver, Colorado, 80209
The Jackson Clinic, PA
Jackson, Tennessee, 38305
NuDirections Clinical Research, Inc.
Lawrenceville, Georgia, 30044
Capital Health-Lawrence OB/GYN
Lawrenceville, New Jersey, 08648
The Center for Women's Health & Wellness, LLC
Lawrenceville, New Jersey, 08684
New Age Medical Research Corporation
Miami, Florida, 33186
Eastern Virginia Medical School
Norfolk, Virginia, 23507
Precision Clinical Research, LLC
Sunrise, Florida, 33351
Vision Clinical Research-Tuscon
Tucson, Arizona, 85712
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
About this study
Official title: A Phase 3 Multi-Center, Double-Blind, Placebo-Controlled, Randomized Study of DARE-BV1 in the Treatment of Bacterial Vaginosis
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.
- Conditions
- Bacterial Vaginosis
- Being tested
- DARE-BV1clindamycin phosphate vaginal gel, 2%
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DARE-BV1clindamycin phosphate vaginal gel, 2%Drug
Also called Placebo vaginal gel (HEC Universal Placebo Gel)
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.
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin phosphate vaginal gel, 2% | Experimental | Not described Receives: Drug: DARE-BV1clindamycin phosphate vaginal gel, 2% |
| Placebo vaginal gel (Universal HEC Placebo Gel) | Placebo comparator | Not described Receives: Drug: DARE-BV1clindamycin phosphate vaginal gel, 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number 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.
Measured: Visit 3 Day 21-30 post randomization
Secondary outcomes (5)
Number of Patients With Clinical Cure at the Interim Assessment Visit (Day 7-14).
Measured: Visit 2 Day 7-14 post randomization
Number of Patients With Bacteriological Cure at the TOC Visit (Day 21-30).
Bacteriological cure is defined as a Nugent score < 4
Measured: Visit 3 Day 21-30 post randomization
Number of Patients With Bacteriological Cure at Interim Assessment Visit, Day 7-14
Measured: Visit 2, Days 7-14 post randomization
Number of Patients With Therapeutic Cure at the TOC Visit (Day 21-30).
Measured: Visit 3 Day 21-30 post randomization
Number of Patients With Therapeutic Cure at the Interim Assessment Visit (Day 7-14).
Measured: Visit 2 Day 7-14 post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start16 Jun 2020
- Primary completion30 Nov 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daré Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370548
- Sponsor's protocol ID
- DARE-BV1-001
- Status last verified
- Dec 2022
- First submitted
- 3 Apr 2020
- Last updated
- 8 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mauck C, Hillier SL, Gendreau J, Dart C, Wu H, Chavoustie S, Sorkin-Wells V, Nicholson-Uhl CS, Perez B, Jacobs M, Zack N, Friend D. Acceptability of Single-dose Clindamycin Gel for Bacterial Vaginosis: A Randomized Controlled Trial. Clin Ther. 2023 May;45(5):415-425. doi: 10.1016/j.clinthera.2023.04.001. Epub 2023 Apr 23.
PubMed 37098453Mauck C, Hillier SL, Gendreau J, Dart C, Chavoustie S, Sorkin-Wells V, Nicholson-Uhl C, Perez B, Jacobs M, Zack N, Friend D. Single-Dose, Bioadhesive Clindamycin 2% Gel for Bacterial Vaginosis: A Randomized Controlled Trial. Obstet Gynecol. 2022 Jun 1;139(6):1092-1102. doi: 10.1097/AOG.0000000000004805. Epub 2022 May 2.
PubMed 35675606
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multi-Center, Double-Blind, Placebo-Controlled, Randomized Study of DARE-BV1 in the Treatment of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT04370548
- Acronym / sponsor ID
- DARE-BV1-001
- Conditions
- Bacterial Vaginosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Daré Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Posted 2 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Clindamycin phosphate vaginal gel, 2% | Experimental | Drug: DARE-BV1clindamycin phosphate vaginal gel, 2% |
| Placebo vaginal gel (Universal HEC Placebo Gel) | Placebo comparator | Drug: DARE-BV1clindamycin phosphate vaginal gel, 2% |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- 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:
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DARE-BV1clindamycin phosphate vaginal gel, 2%Also: Placebo vaginal gel (HEC Universal Placebo Gel)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. | Drug | Clindamycin phosphate vaginal gel, 2%, Placebo vaginal gel (Universal HEC Placebo Gel) |
Primary outcome
Number of Patients With Clinical Cure at the TOC Visit (Day 21-30).
Time frame: Visit 3 Day 21-30 post randomization
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.
5 secondary outcomes
Number of Patients With Clinical Cure at the Interim Assessment Visit (Day 7-14).
Time frame: Visit 2 Day 7-14 post randomization
Number of Patients With Bacteriological Cure at the TOC Visit (Day 21-30).
Time frame: Visit 3 Day 21-30 post randomization
Number of Patients With Bacteriological Cure at Interim Assessment Visit, Day 7-14
Time frame: Visit 2, Days 7-14 post randomization
Number of Patients With Therapeutic Cure at the TOC Visit (Day 21-30).
Time frame: Visit 3 Day 21-30 post randomization
Number of Patients With Therapeutic Cure at the Interim Assessment Visit (Day 7-14).
Time frame: Visit 2 Day 7-14 post randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37098453Mauck C, Hillier SL, Gendreau J, Dart C, Wu H, Chavoustie S, Sorkin-Wells V, Nicholson-Uhl CS, Perez B, Jacobs M, Zack N, Friend D. Acceptability of Single-dose Clindamycin Gel for Bacterial Vaginosis: A Randomized Controlled Trial. Clin Ther. 2023 May;45(5):415-425. doi: 10.1016/j.clinthera.2023.04.001. Epub 2023 Apr 23.
- Derived from this study: PubMed 35675606Mauck C, Hillier SL, Gendreau J, Dart C, Chavoustie S, Sorkin-Wells V, Nicholson-Uhl C, Perez B, Jacobs M, Zack N, Friend D. Single-Dose, Bioadhesive Clindamycin 2% Gel for Bacterial Vaginosis: A Randomized Controlled Trial. Obstet Gynecol. 2022 Jun 1;139(6):1092-1102. doi: 10.1097/AOG.0000000000004805. Epub 2022 May 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DARE-BV1clindamycin phosphate vaginal gel, 2% in people with Bacterial Vaginosis, run by Daré Bioscience, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Clinical Cure at the TOC Visit (Day 21-30). (time frame: Visit 3 Day 21-30 post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04370548, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.