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Effects of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Primary endpoints: details revised at 2 of 8 entries · Study sites: 0 to 1 · Start date changed from estimate of Aug 28, 2026 to Sep 1, 2026 · 2 more Show 5 more changesShow less
    • Primary endpoints: details revised at 2 of 8 entries
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 28, 2026 to Sep 1, 2026
    • Interventions: DRSP/EE (Drug), LNG/EE (Drug), NET/EE (Drug), NGM/EE (Drug), VX-407 (Drug) to DRSP/EE (Drug), LNG/EE (Drug), NET/EE (Drug), NGM/EE (Drug), VX-407 (Drug)
    • Eligibility criteria expanded, about 4 words
  2. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives.
Trial Details
NCT Number NCT07792408
Lead Sponsor Vertex Pharmaceuticals Incorporated
Conditions Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Enrollment 148 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov