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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.

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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

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At a glance

  • Drugs Hydroxyprogesterone (Primary) ; Hydroxyprogesterone
  • Indications Preterm birth
  • Focus Registrational; Therapeutic Use
  • Sponsors Lipocine
  • Most Recent Events

    • 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.
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