Open-label, Randomized, Parallel Group, Study of Efficacy and Safety of a Transdermal Contraceptive Delivery System (TCDS) in Comparison to a Low-dose Oral Contraceptive Containing 0.02 mg EE and 0.1 mg LNG in a 21-day Regimen.
Phase of Trial: Phase III
Latest Information Update: 27 Jul 2017
At a glance
- Drugs Ethinylestradiol/levonorgestrel (Primary) ; Ethinylestradiol/levonorgestrel (Primary)
- Indications Pregnancy
- Focus Registrational; Therapeutic Use
- Acronyms NEW CHOICE
- Sponsors Agile Therapeutics
- 27 Jul 2017 According to an Agile Therapeutics media release, the US FDA has accepted for review the Company's NDA resubmission for Twirla (AG200-15). The NDA resubmission was submitted on June 26, 2017. The FDA stated that it considers the resubmission to be a complete response to the CRL and established December 26, 2017 as the Prescription Drug User Fee Act (PDUFA) goal date.
- 01 Jun 2013 Results were presented at the American College of Obstetricians and Gynecologists' (ACOG) 61st Annual Clinical Meeting, according to an Agile Therapeutics media release.
- 08 May 2013 Tolerability results presented at the 61st Annual Clinical Meeting of the American College of Obstetricians and Gynecologists.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History