Trial Profile
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.
Status:
Planning
Phase of Trial:
Phase III
Latest Information Update: 29 Jun 2017
Price :
$35
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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.