Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05354050 | Pharmacokinetic Study of DARE-BV1 | PHASE1 | COMPLETED | 21 | — | — | Nov 3, 2020 | Dec 2, 2020 | Apr 29, 2022 | 1 | United States |
Evaluate the PK of a single dose of DARE-BV1 in healthy female subjects by assessment of plasma and vaginal clindamycin concentrations
| Arm | Type | Description |
|---|---|---|
| DARE-BV1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| DARE-BV1 | DRUG | 2% Clindamycin 100 MG |
Inclusion Criteria: 1. Subjects must be females \>= 18 years of age with no known medical conditions that, in the Investigator's opinion, may interfere with study participation. 2. Subjects may engage in heterosexual intercourse between Screening and Day-1, but must agree to abstain from sexual int...