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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)

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Recruitment opened Show 6 more changesShow less
    • Enrollment increased: 30 → 42 participants
    • Study sites: 7 to 9
    • Start date changed from estimate of Jun 15, 2026 to Aug 15, 2026
    • Eligibility criteria expanded, about 57 words
    • Secondary endpoints: details revised at 3 of 12 entries
    • Study description expanded, about 15 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07663838
Lead Sponsor Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions
(from sponsor)		 Randomized, Open-label, Safety, Tolerability, Pharmacokinetics, Bacterial Vaginosis
Related terms Vaginosis, Bacterial
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov