An Open-Label, Randomized, Phase 3 Study of the Contraceptive Efficacy and Safety of Agile Transdermal Contraceptive Delivery System in Comparison to an Oral Contraceptive (OC) Containing 150 mcg LNG and 30 mcg EE
Phase of Trial: Phase III
Latest Information Update: 22 Dec 2017
At a glance
- Drugs Ethinylestradiol/levonorgestrel (Primary) ; Ethinylestradiol/levonorgestrel (Primary)
- Indications Pregnancy
- Focus Registrational; Therapeutic Use
- Acronyms NEW CHOICE II
- Sponsors Agile Therapeutics
- 22 Dec 2017 According to an Agile Therapeutics media release, the Company has submitted an amendment to the NDA in response to an information request from the FDA on the issues related to quality adhesion test methods cited in the CRL. The facility also provided the FDA responses addressing each of the observations made during the FDA's facility inspection. The CRL acknowledges receipt of the Company's NDA amendment and states that the amendment was not reviewed prior to the FDA's action.
- 22 Dec 2017 According to an Agile Therapeutics media release, the U.S. Food and Drug Administration issued a complete response letter (CRL) in response to the New Drug Application (NDA) resubmission for Twirla (AG200-15). The CRL states that the FDA has determined that it cannot approve the NDA in its present form. The CRL recommends that the Company address the implications of clinical trial subject patch compliance and the withdrawal and dropout rates and does not identify any specific safety issues.
- 22 Dec 2017 According to an Agile Therapeutics media release, the CRL identifies deficiencies relating to quality adhesion test methods and also noted that observations identified during an inspection of a facility of the Company's third-party manufacturer, Corium International Inc., (Corium), for the Twirla NDA must be resolved. The CRL also questions the in vivo adhesion properties of Twirla and their potential relationship to the SECURE phase 3 clinical trial results.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History