Bacterial VaginosisPhase 1NCT05354050
Pharmacokinetic Study of DARE-BV1
A Phase 1 study testing DARE-BV1 in people with Bacterial Vaginosis, run by Daré Bioscience, Inc. at 1 site in United States.
Trial summary
Single-Center, Phase 1, Single-dose PK study of DARE-BV1 (2% clindamycin phosphate vaginal gel, 100mg) under development for the treatment of bacterial vaginosis (BV). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- DARE-BV1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2020to 2 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be females >= 18 years of age with no known medical conditions that, in the Investigator's opinion, may interfere with study participation.
- Subjects may engage in heterosexual intercourse between Screening and Day-1, but must agree to abstain from sexual intercourse and/or sexual activity throughout the 7 days following treatment.
- Subjects of childbearing potential should use adequate birth control between Screening and Day 1 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) without spermicide. Subjects in same sex relationships, or monogamous relationships with vasectomized males, may also participate. Abstinence may also be acceptable, per the Investigator's judgment. Oral or transdermal hormonal contraceptives must be in use for 1 full cycle (e.g., 4 to 8 weeks) prior to study drug application. Injectable or implanted contraceptives (e.g., Depo-Provera, Nexplanon, or hormonal IUD) must have been injected/inserted at least 7 days prior to study drug application.
- Subjects who are not of childbearing potential will not need a urine pregnancy test prior to dosing or at subsequent visits. Subjects are considered to be of non-child bearing potential if one of the following is satisfied:
- Postmenopausal for at least 1 year prior to the Screening Visit (Visit 1) (defined as amenorrheic for more than 1 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 performed at least 3 months prior to study drug application.
- Subjects must be willing to refrain from the use of all intra-vaginal products (e.g., douches, feminine deodorant sprays, female condoms, spermicides, vaginal moisturizers or lubricants, tampons, vaginal birth control rings [e.g., NuvaRing®], and diaphragms) through the study or Study Exit/Early Discontinuation.
Who cannot join
- Subjects with active BV, vulvovaginitis, or other active infectious causes of cervicitis, vaginitis, or vulvitis, based on the results of the thorough clinical assessments and testing as described above or genital lesions or ulcers consistent with HPV, Herpes simplex, syphilis, chancroid, etc.). Subjects with a history of genital herpes or condylomata who have been asymptomatic for at least 6 months may be considered for eligibility.
- Potential subjects who are pregnant or are breastfeeding or, if of child-bearing potential, unwilling to practice acceptable means of birth control or abstinence during the study as described above.
- Subjects with a vaginal, vulvar, or genitourinary condition that, according to the Investigator's judgment, may confound the interpretation of clinical assessments. This includes urinary tract infections requiring antibiotics.
- Subjects with a history of regional enteritis, ulcerative colitis, or a history of Clostridium difficile-associated diarrhea.
- Subjects with known current drug or alcohol abuse that could impact study compliance.
- Subjects currently receiving or who have received antifungal or antibacterial therapy (systemic or intravaginal) within 14 days of the Screening Visit (Visit 1).
Show all 10Show fewer
- Subjects who have used any other investigational product within 30 days of the Screening Visit (Visit 1).
- Subjects with HPV 16 or 18 at screening (performed on subjects >25 years old).
- Subjects with known sensitivity to clindamycin phosphate or other lincosamides or any of the inactive ingredients in the study drug.
- Subjects with a history of any severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation or study treatment administration or could interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
ICON Early Phase Services, LLC
San Antonio, Texas, 78209
About this study
Official title: A Phase 1 Single-center Pharmacokinetic Study of DARE-BV1 in Healthy Female Subjects
Single-Center, Phase 1, Single-dose PK study of DARE-BV1 (2% clindamycin phosphate vaginal gel, 100mg) under development for the treatment of bacterial vaginosis (BV).
- Conditions
- Bacterial Vaginosis
- Being tested
- DARE-BV1
- 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-BV1Drug
2% Clindamycin 100 MG
| Study group | Role | What they receive |
|---|---|---|
| DARE-BV1 | Experimental | Not described Receives: Drug: DARE-BV1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Pharmacokinetics (PK)
Evaluate the PK of a single dose of DARE-BV1 in healthy female subjects by assessment of plasma and vaginal clindamycin concentrations
Measured: 7 days
Secondary outcomes (1)
Safety and Tolerability by evaluation of Treatment Emergent Adverse Events
Assess the safety and tolerability of DARE-BV1 by looking at TEAEs \& local site reactions
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start3 Nov 2020
- Primary completion18 Nov 2020
- Study completion2 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daré Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Mauck, MD, Study director, Dare Bioscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354050
- Sponsor's protocol ID
- DARE-BV1-PK1
- Status last verified
- Apr 2022
- First submitted
- 25 Apr 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single-center Pharmacokinetic Study of DARE-BV1 in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT05354050
- Acronym / sponsor ID
- DARE-BV1-PK1
- Conditions
- Bacterial Vaginosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Daré Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-Center, Phase 1, Single-dose PK study of DARE-BV1 (2% clindamycin phosphate vaginal gel, 100mg) under development for the treatment of bacterial vaginosis (BV).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DARE-BV1 | Experimental | Drug: DARE-BV1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must be females >= 18 years of age with no known medical conditions that, in the Investigator's opinion, may interfere with study participation.
- Subjects may engage in heterosexual intercourse between Screening and Day-1, but must agree to abstain from sexual intercourse and/or sexual activity throughout the 7 days following treatment.
- Subjects of childbearing potential should use adequate birth control between Screening and Day 1 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) without spermicide. Subjects in same sex relationships, or monogamous relationships with vasectomized males, may also participate. Abstinence may also be acceptable, per the Investigator's judgment. Oral or transdermal hormonal contraceptives must be in use for 1 full cycle (e.g., 4 to 8 weeks) prior to study drug application. Injectable or implanted contraceptives (e.g., Depo-Provera, Nexplanon, or hormonal IUD) must have been injected/inserted at least 7 days prior to study drug application.
- Subjects who are not of childbearing potential will not need a urine pregnancy test prior to dosing or at subsequent visits. Subjects are considered to be of non-child bearing potential if one of the following is satisfied:
- Subjects must be willing to refrain from the use of all intra-vaginal products (e.g., douches, feminine deodorant sprays, female condoms, spermicides, vaginal moisturizers or lubricants, tampons, vaginal birth control rings [e.g., NuvaRing®], and diaphragms) through the study or Study Exit/Early Discontinuation.
Key exclusion criteria (10 listed)
- Subjects with active BV, vulvovaginitis, or other active infectious causes of cervicitis, vaginitis, or vulvitis, based on the results of the thorough clinical assessments and testing as described above or genital lesions or ulcers consistent with HPV, Herpes simplex, syphilis, chancroid, etc.). Subjects with a history of genital herpes or condylomata who have been asymptomatic for at least 6 months may be considered for eligibility.
- Potential subjects who are pregnant or are breastfeeding or, if of child-bearing potential, unwilling to practice acceptable means of birth control or abstinence during the study as described above.
- Subjects with a vaginal, vulvar, or genitourinary condition that, according to the Investigator's judgment, may confound the interpretation of clinical assessments. This includes urinary tract infections requiring antibiotics.
- Subjects with a history of regional enteritis, ulcerative colitis, or a history of Clostridium difficile-associated diarrhea.
- Subjects 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-BV12% Clindamycin 100 MG | Drug | DARE-BV1 |
Primary outcome
Evaluate the Pharmacokinetics (PK)
Time frame: 7 days
Evaluate the PK of a single dose of DARE-BV1 in healthy female subjects by assessment of plasma and vaginal clindamycin concentrations
1 secondary outcome
Safety and Tolerability by evaluation of Treatment Emergent Adverse Events
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
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WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
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A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
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A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
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Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
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.
Christine Mauck, MD study director
Dare Bioscience, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DARE-BV1 in people with Bacterial Vaginosis, run by Daré Bioscience, Inc. at 1 site 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 8 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 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate the Pharmacokinetics (PK) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2022.