A pivotal phase III study of Hydroxyprogesterone caproate (LPCN-1107) in reducing the risk of preterm birth (PTB) in women with singleton pregnancy who have a history of singleton spontaneous PTB.
Phase of Trial: Phase III
Latest Information Update: 26 Jun 2017
At a glance
- Drugs Hydroxyprogesterone (Primary) ; Hydroxyprogesterone
- Indications Preterm birth
- Focus Registrational; Therapeutic Use
- Sponsors Lipocine
- 26 Jun 2017 According to a company media release, Lipocine has submitted a Special Protocol Assessment ("SPA") request to the U.S. Food and Drug Administration as part of the ongoing interaction with the FDA on the detailed design of the planned Phase 3 clinical development program for LPCN 1107 for prevention of recurrent preterm birth ("PTB") with history of singleton pregnancy.
- 11 Mar 2017 New trial record
- 06 Mar 2017 According to a Lipocine media release, the company plans to submit the LPCN-1107 Phase 3 protocol to the FDA via a Special Protocol Assessment (SPA) in the first half of 2017.