An AllTrials project

NCT05617820: An overdue trial by Teva Pharmaceuticals USA

This trial is overdue. It was due to report 2 months, 2 weeks ago.

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  • We can only rely on the structured data that sponsors put into the registry: they may enter incorrect or incomplete data.
  • Reporting in a journal is not enough. The FDAAA rules state that the trial must be reported on ClinicalTrials.gov.
  • Terminated trials are required to report results. Only withdrawn trials (which never recruited a single patient) are not.

Full data

Full entry on ClinicalTrials.gov NCT05617820
Title A Randomized, Double-Blind, Placebo-Controlled, Parallel- Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Estradiol Vaginal Inserts 4 mcg (Teva Pharmaceuticals, Inc.) With IMVEXXY® (Estradiol Vaginal Inserts) (TherapeuticsMD, Inc.) in the Treatment of Dyspareunia in Women With Vulvar and Vaginal Atrophy
Results Status Overdue
ACT or pACT? This is what FDAAA officially calls an "Applicable Clinical Trial"
Start date Nov. 15, 2022
Completion date March 15, 2024
Required reporting date March 15, 2025, midnight
Actual reporting date None
Date last checked at ClinicalTrials.gov May 29, 2025
Days late 75