Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury
Summary
The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Brain Injuries
Intervention
Progesterone, Lipid emulsion without progesterone
Location
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
United States
15213
Status
Recruiting
Source
BHR Pharma, LLC
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01143064
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Receptors, Progesterone
Specific proteins found in or on cells of progesterone target tissues that specifically combine with progesterone. The cytosol progesterone-receptor complex then associates with the nucleic acids to initiate protein synthesis. There are two kinds of progesterone receptors, A and B. Both are induced by estrogen and have short half-lives.
Progesterone Congeners
Steroidal compounds related to PROGESTERONE, the major mammalian progestational hormone. Progesterone congeners include important progesterone precursors in the biosynthetic pathways, metabolites, derivatives, and synthetic steroids with progestational activities.
Progesterone
The major progestational steroid that is secreted primarily by the CORPUS LUTEUM and the PLACENTA. Progesterone acts on the UTERUS, the MAMMARY GLANDS and the BRAIN. It is required in EMBRYO IMPLANTATION; PREGNANCY maintenance, and the development of mammary tissue for MILK production. Progesterone, converted from PREGNENOLONE, also serves as an intermediate in the biosynthesis of GONADAL STEROID HORMONES and adrenal CORTICOSTEROIDS.
Progesterone-binding Globulin
A glycoprotein migrating as alpha 1-globulin, molecular weight 70,000 to 120,000. The protein, which is present in increased amounts in the plasma during pregnancy, binds mainly progesterone, with other steroids including testosterone competing weakly.
Progesterone Reductase
An enzyme that catalyzes the reduction of a 3 beta-hydroxy-delta(5)-steroid to 3-oxo-delta(4)-steroid in the presence of NAD. It converts pregnenolone to progesterone and dehydroepiandrosterone to androstenedione. EC 1.1.1.145.
Clinical Trials
Progesterone Treatment of Blunt Traumatic Brain Injury
The purpose of this study is to determine if progesterone treatment safely reduces brain swelling and damage after injury.
The primary purpose of this study is to determine the effects of a full dose (300 mg at hs) of oral micronized progesterone (OMP) on vasomotor symptoms [VMS] (hot flushes/night sweats), on...
Progesterone for the Treatment of Traumatic Brain Injury
The ProTECT study will determine if intravenous (IV) progesterone (started within 4 hours of injury and given for a total of 96 hours), is more effective than placebo for treating victims...
Postmenopausal Women Estrogen and Progesterone Infusion
The purpose of the study is to study the effects of aging, estrogen and progesterone on the brain. Specifically, we want to look at how the hypothalamus and pituitary (two small glands in...
The objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferati...
PubMed Articles
Progesterone attenuates early brain injury after subarachnoid hemorrhage in rats.
Although the neuroprotective effects of progesterone against early brain injury (EBI) after trauma have been demonstrated in several studies, whether progesterone reduces EBI after subarachnoid hemorr...
Progesterone, brain-derived neurotrophic factor and neuroprotection.
While the effects of progesterone in the CNS, like those of estrogen, have generally been considered within the context of reproductive function, growing evidence supports its importance in regulating...
TBI is a complex disease process caused by a cascade of systemic events. Attention is now turning to drugs that act on multiple pathways to enhance survival and functional outcomes. Progesterone has b...
Glucocorticoid Receptor Mediates the Effect of Progesterone on Uterine Natural Killer Cells.
PROBLEM: Uterine natural killer cells (uNK) do not express progesterone receptor, but express glucocorticoid receptor (GR). So, we speculate that progesterone may regulate uNK cells through a GR-media...
Cytokines play an important role in the pathophysiology of traumatic brain injury (TBI). This study was designed to determine the effects of administering progesterone (P) and estrogen (E), alone and...
