Trial · NCT04370548
DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)
NCT04370548, Phase 3, Completed, Daré Bioscience, Inc.; results first posted 2021-07-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE). Trials, record NCT04370548. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04370548
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)
- NCT number
- NCT04370548
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 307 participants, actual
- Lead sponsor
- Daré Bioscience, Inc.
- Conditions
- Bacterial Vaginosis
- Interventions
- DARE-BV1clindamycin phosphate vaginal gel, 2%
- First posted
- 2020-05-01
- Last updated
- 2022-12-08
- Results first posted
- 2021-07-02
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Clinical Cure at the TOC Visit (Day 21-30). | 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. |
| Secondary | Number of Patients With Clinical Cure at the Interim Assessment Visit (Day 7-14). | Visit 2 Day 7-14 post randomization | |
| Secondary | Number of Patients With Bacteriological Cure at the TOC Visit (Day 21-30). | Visit 3 Day 21-30 post randomization | Bacteriological cure is defined as a Nugent score \< 4 |
| Secondary | Number of Patients With Bacteriological Cure at Interim Assessment Visit, Day 7-14 | Visit 2, Days 7-14 post randomization | |
| Secondary | Number of Patients With Therapeutic Cure at the TOC Visit (Day 21-30). | Visit 3 Day 21-30 post randomization | |
| Secondary | Number of Patients With Therapeutic Cure at the Interim Assessment Visit (Day 7-14). | Visit 2 Day 7-14 post randomization | |
| Other | Number of Patients With Clinical Cure at the Test of Cure Visit (21-30) | Visit 3, Days 21-30 post randomization | |
| Other | Number of Patients With Clinical Cure at Interim Assessment Visit, Days 7-14, PP Population | Visit 2, Days 7-14 post randomization | |
| Other | Number of Patients With Bacteriological Cure at Test of Cure Visit, Days 21-30, PP Population | Visit 3, Days 21-30 post randomization | |
| Other | Number of Patients With Bacteriological Cure, Interim Assessment Visit, Days 7-14, PP Population | Visit 2, Days 7-14 post randomization |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Clinical Cure at the TOC Visit (Day 21-30). | Visit 3 Day 21-30 post randomization | Clinical Cure of the mITT Population (missing data were treated as Treatment Failure) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Clinical Cure at the Interim Assessment Visit (Day 7-14). | Visit 2 Day 7-14 post randomization | mITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Bacteriological Cure at the TOC Visit (Day 21-30). | Visit 3 Day 21-30 post randomization | mITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Bacteriological Cure at Interim Assessment Visit, Day 7-14 | Visit 2, Days 7-14 post randomization | mITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Therapeutic Cure at the TOC Visit (Day 21-30). | Visit 3 Day 21-30 post randomization | mITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Therapeutic Cure at the Interim Assessment Visit (Day 7-14). | Visit 2 Day 7-14 post randomization | mITT Population | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Patients With Clinical Cure at the Test of Cure Visit (21-30) | Visit 3, Days 21-30 post randomization | Per Protocol (PP) Population | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Patients With Clinical Cure at Interim Assessment Visit, Days 7-14, PP Population | Visit 2, Days 7-14 post randomization | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Patients With Bacteriological Cure at Test of Cure Visit, Days 21-30, PP Population | Visit 3, Days 21-30 post randomization | Per Protocol Population | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Patients With Bacteriological Cure, Interim Assessment Visit, Days 7-14, PP Population | Visit 2, Days 7-14 post randomization | PP Population | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Clinical Cure at the TOC Visit (Day 21-30). | Clindamycin Phosphate Vaginal Gel, 2% | 86 | Participants | ||
| Number of Patients With Clinical Cure at the TOC Visit (Day 21-30). | Placebo Vaginal Gel (Universal HEC Placebo Gel) | 21 | Participants | ||
| Number of Patients With Clinical Cure at the Interim Assessment Visit (Day 7-14). | Clindamycin Phosphate Vaginal Gel, 2% | 93 | Participants | ||
| Number of Patients With Clinical Cure at the Interim Assessment Visit (Day 7-14). | Placebo Vaginal Gel (Universal HEC Placebo Gel) | 14 | Participants | ||
| Number of Patients With Bacteriological Cure at the TOC Visit (Day 21-30). | Clindamycin Phosphate Vaginal Gel, 2% | 53 | Participants | ||
| Number of Patients With Bacteriological Cure at the TOC Visit (Day 21-30). | Placebo Vaginal Gel (Universal HEC Placebo Gel) | 3 | Participants | ||
| Number of Patients With Bacteriological Cure at Interim Assessment Visit, Day 7-14 | Clindamycin Phosphate Vaginal Gel, 2% | 50 | Participants | ||
| Number of Patients With Bacteriological Cure at Interim Assessment Visit, Day 7-14 | Placebo Vaginal Gel (Universal HEC Placebo Gel) | 2 | Participants | ||
| Number of Patients With Therapeutic Cure at the TOC Visit (Day 21-30). | Clindamycin Phosphate Vaginal Gel, 2% | 45 | Participants | ||
| Number of Patients With Therapeutic Cure at the TOC Visit (Day 21-30). | Placebo Vaginal Gel (Universal HEC Placebo Gel) | 3 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clindamycin Phosphate Vaginal Gel, 2% | 204 | |
| Overall Study | STARTED | Placebo Vaginal Gel (Universal HEC Placebo Gel) | 103 | |
| Overall Study | COMPLETED | Clindamycin Phosphate Vaginal Gel, 2% | 190 | |
| Overall Study | COMPLETED | Placebo Vaginal Gel (Universal HEC Placebo Gel) | 100 | |
| Overall Study | NOT COMPLETED | Clindamycin Phosphate Vaginal Gel, 2% | 14 | |
| Overall Study | NOT COMPLETED | Placebo Vaginal Gel (Universal HEC Placebo Gel) | 3 |
Source ClinicalTrials.gov
Adverse events106
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vulvovaginal candidiasis | Infections and infestations | Clindamycin Phosphate Vaginal Gel, 2% | 35 | 203 | 37 |
| other | Vulvovaginal candidiasis | Infections and infestations | Placebo Vaginal Gel (Universal HEC Placebo Gel) | 4 | 103 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Clindamycin Phosphate Vaginal Gel, 2% | 1 | 203 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Vaginal Gel (Universal HEC Placebo Gel) | 0 | 103 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Clindamycin Phosphate Vaginal Gel, 2% | 1 | 203 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo Vaginal Gel (Universal HEC Placebo Gel) | 0 | 103 | 0 |
| other | Ear Pain | Ear and labyrinth disorders | Clindamycin Phosphate Vaginal Gel, 2% | 1 | 203 | 1 |
| other | Ear Pain | Ear and labyrinth disorders | Placebo Vaginal Gel (Universal HEC Placebo Gel) | 0 | 103 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Clindamycin Phosphate Vaginal Gel, 2% | 2 | 203 | 2 |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo Vaginal Gel (Universal HEC Placebo Gel) | 2 | 103 | 2 |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clindamycin Phosphate Vaginal Gel, 2% | 0 | 203 |
| Total, all-cause mortality | Placebo Vaginal Gel (Universal HEC Placebo Gel) | 0 | 103 |
| Total, other adverse events | Clindamycin Phosphate Vaginal Gel, 2% | 76 | 203 |
| Total, other adverse events | Placebo Vaginal Gel (Universal HEC Placebo Gel) | 28 | 103 |
| Total, serious adverse events | Clindamycin Phosphate Vaginal Gel, 2% | 0 | 203 |
| Total, serious adverse events | Placebo Vaginal Gel (Universal HEC Placebo Gel) | 1 | 103 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons14
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Clindamycin Phosphate Vaginal Gel, 2% vs Placebo Vaginal Gel (Universal HEC Placebo Gel): Number of Patients With Bacteriological Cure at Interim Assessment Visit, Day 7-14 | Trial comparisons |
| Clindamycin Phosphate Vaginal Gel, 2% vs Placebo Vaginal Gel (Universal HEC Placebo Gel): Number of Patients With Bacteriological Cure at Test of Cure Visit, Days 21-30, PP Population | Trial comparisons |
| Clindamycin Phosphate Vaginal Gel, 2% vs Placebo Vaginal Gel (Universal HEC Placebo Gel): Number of Patients With Bacteriological Cure at the TOC Visit (Day 21-30). | Trial comparisons |
| Clindamycin Phosphate Vaginal Gel, 2% vs Placebo Vaginal Gel (Universal HEC Placebo Gel): Number of Patients With Bacteriological Cure, Interim Assessment Visit, Days 7-14, PP Population | Trial comparisons |
| Clindamycin Phosphate Vaginal Gel, 2% vs Placebo Vaginal Gel (Universal HEC Placebo Gel): Number of Patients With Therapeutic Cure at the Interim Assessment Visit (Day 7-14). | Trial comparisons |
| Clindamycin Phosphate Vaginal Gel, 2% vs Placebo Vaginal Gel (Universal HEC Placebo Gel): Number of Patients With Therapeutic Cure at Test of Cure Visit, Days 21-30; PP Population | Trial comparisons |
| Clindamycin Phosphate Vaginal Gel, 2% vs Placebo Vaginal Gel (Universal HEC Placebo Gel): Number of Patients With Clinical Cure at the TOC Visit (Day 21-30). | Trial comparisons |
| Clindamycin Phosphate Vaginal Gel, 2% vs Placebo Vaginal Gel (Universal HEC Placebo Gel): Number of Patients With Therapeutic Cure, Interim Assessment Visit, Days 7-14, PP Population | Trial comparisons |
| Clindamycin Phosphate Vaginal Gel, 2% vs Placebo Vaginal Gel (Universal HEC Placebo Gel): Number of Patients With Therapeutic Cure at the TOC Visit (Day 21-30). | Trial comparisons |
| Clindamycin Phosphate Vaginal Gel, 2% vs Placebo Vaginal Gel (Universal HEC Placebo Gel): Number of Patients With Clinical Cure at the Interim Assessment Visit (Day 7-14). | Trial comparisons |
1 to 10 of 14
See all 14 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04370548
GET https://conductscience.org/api/trials/v1/NCT04370548/results?page=2