Pharmacokinetic Study of DARE-BV1
Primary Purpose
Bacterial Vaginosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DARE-BV1
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Vaginosis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
Sites / Locations
- ICON Early Phase Services, LLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DARE-BV1
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05354050
Brief Title
Pharmacokinetic Study of DARE-BV1
Official Title
A Phase 1 Single-center Pharmacokinetic Study of DARE-BV1 in Healthy Female Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
November 18, 2020 (Actual)
Study Completion Date
December 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daré Bioscience, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DARE-BV1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DARE-BV1
Intervention Description
2% Clindamycin 100 MG
Primary Outcome Measure Information:
Title
Evaluate the Pharmacokinetics (PK)
Description
Evaluate the PK of a single dose of DARE-BV1 in healthy female subjects by assessment of plasma and vaginal clindamycin concentrations
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Safety and Tolerability by evaluation of Treatment Emergent Adverse Events
Description
Assess the safety and tolerability of DARE-BV1 by looking at TEAEs & local site reactions
Time Frame
21 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Mauck, MD
Organizational Affiliation
Dare Bioscience, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
ICON Early Phase Services, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Pharmacokinetic Study of DARE-BV1
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