The Effect of Vaginal Progesterone Administration in the Prevention of Preterm Birth in Women With a Short Cervix [Vaginal Progesterone Bioadhesive Gel (Prochieve)® Extending Gestation A New Therapy for Short Cervix - Trial (PREGNANT Short Cervix - Trial)]

Trial Profile

The Effect of Vaginal Progesterone Administration in the Prevention of Preterm Birth in Women With a Short Cervix [Vaginal Progesterone Bioadhesive Gel (Prochieve)® Extending Gestation A New Therapy for Short Cervix - Trial (PREGNANT Short Cervix - Trial)]

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Jun 2015

At a glance

  • Drugs Progesterone (Primary)
  • Indications Preterm birth
  • Focus Registrational; Therapeutic Use
  • Acronyms PREGNANT
  • Sponsors Columbia Laboratories; Juniper Pharmaceuticals
  • Most Recent Events

    • 27 Feb 2012 The US FDA has issued a complete response letter to Watson Pharmaceuticals based on the results from this trial.
    • 27 Feb 2012 Additional results from this trial presented in a Watson Pharmaceuticals media release.
    • 14 Dec 2011 Results from a meta-analysis of five clinical trials, including the PREGNANCY trial, published in a Columbia Laboratories media release.
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