||||||||||levonorgestrel (AG890) / Agile Therap, Twirla (ethinyl estradiol/levonorgestrel) / Agile Therap, Corium Clinical, PK/PD data, Journal: Extended regimen of a levonorgestrel/ethinyl estradiol transdermal delivery system: Predicted serum hormone levels using a population pharmacokinetic model. (Pubmed Central) - Dec 28, 2022 P1 These results indicate that a 12-week extended LNG/EE regimen would provide similar systemic hormonal exposure as that seen by week 3 in a standard 28-day regimen, without further hormonal accumulation. The data support the safe use of a non-daily, low-dose hormonal contraceptive in an extended regimen but should be confirmed in a clinical PK study.
||||||||||estradiol / Teva, levonorgestrel (AG890) / Agile Therap, Twirla (ethinyl estradiol/levonorgestrel) / Agile Therap, Corium Clinical, P3 data, Journal: Efficacy, Safety, and Tolerability of a Levonorgestrel/Ethinyl Estradiol Transdermal Delivery System: Phase 3 Clinical Trial Results. (Pubmed Central) - Oct 20, 2021 The TDS safety and tolerability profile was consistent with other similar dose combined hormonal contraceptives. Results of this phase 3 study supported the FDA approval of TWIRLA® for prevention of pregnancy in women with BMI <30 kg/m.
||||||||||levonorgestrel (AG890) / Agile Therap Enrollment closed: Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches (clinicaltrials.gov) - Jul 9, 2012 P1/2, N=36, Active, not recruiting, Sponsor: Agile Therapeutics Results of this phase 3 study supported the FDA approval of TWIRLA® for prevention of pregnancy in women with BMI <30 kg/m. Recruiting --> Active, not recruiting