Trial Profile

A long-term prospective, multi-center clinical post-marketing requirement study (PMR) comparing the risks of venous thromboembolism (VTE) and arterial thromboembolism (ATE) in new users of Twirla to new users of combined hormonal contraceptives (CHCs) and Ortho Evra generic patches

Status: Recruiting

Phase of Trial: Phase IV

Latest Information Update: 07 Feb 2023

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At a glance

07 Feb 2023 New trial record
01 Feb 2023 According to an Agile Therapeutics media release, interim safety data reporting to the FDA is due in November 2029, and the final PMR study report is scheduled to be submitted to the FDA in November 2035.
01 Feb 2023 According to an Agile Therapeutics media release, the FDA agreed with the Company proposal to address this PMR using electronic health records (EHR) and insurance claims from a large database from multiple healthcare systems.

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