Abstract

? PILOT PROJECT Feasibility and Safety of Vaginal Administration of 17-hydroxyprogesterone Caproate In this pilot study we are proposing to develop a vaginal formulation of 17-hydroxyprogesterone caproate (17- OHPC). We will first formulate a preparation of 17-OHPC that will be tested in rabbits to assure its tolerability. Once developed, we will determine how much of the compound enters the circulation. We will then test the formulation in non-pregnant women and measure the amount of medication reaching the blood. Once we have demonstrated that the preparation is well tolerated by women, we can the study the impact of the medication on those genes that respond to the progesterone hormone and eventually test the formulation in pregnant women who are now receiving this medication by injection. We postulate that the vaginal preparation will be better tolerated than injections and will be as effective if not more so.

Public Health Relevance

? PILOT PROJECT Feasibility and Safety of Vaginal Administration of 17-hydroxyprogesterone Caproate This proposal focuses on developing a vaginal formulation of 17-OHPC. We will use rabbits to formulate and test a vaginal preparation of 17-OHPC then will assess the impact of this formulation of systemic levels of the medication and evaluate its tolerability.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Specialized Center--Cooperative Agreements (U54)
Project #
2U54HD047905-11
Application #
8984568
Study Section
Special Emphasis Panel (ZHD1-DSR-A (50))
Project Start
Project End
Budget Start
2015-08-01
Budget End
2016-06-30
Support Year
11
Fiscal Year
2015
Total Cost
$14,112
Indirect Cost
$25,252

  Institution

Name
Magee-Women's Research Institute and Foundation
Department
Type
DUNS #
119132785
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213

  Publications

Lemon, Lara S; Caritis, Steve N; Venkataramanan, Raman et al. (2018) Methadone Versus Buprenorphine for Opioid Use Dependence and Risk of Neonatal Abstinence Syndrome. Epidemiology 29:261-268
Caritis, Steve N; Hankins, Gary; Hebert, Mary et al. (2018) Impact of Pregnancy History and 17-Hydroxyprogesterone Caproate on Cervical Cytokines and Matrix Metalloproteinases. Am J Perinatol 35:470-480
Lemon, Lara S; Naimi, Ashley; Caritis, Steve N et al. (2018) The Role of Preterm Birth in the Association Between Opioid Maintenance Therapy and Neonatal Abstinence Syndrome. Paediatr Perinat Epidemiol 32:213-222
Bustos, Martha L; Caritis, Steve N; Jablonski, Kathleen A et al. (2017) The association among cytochrome P450 3A, progesterone receptor polymorphisms, plasma 17-alpha hydroxyprogesterone caproate concentrations, and spontaneous preterm birth. Am J Obstet Gynecol 217:369.e1-369.e9
Bastian, Jaime R; Chen, Huijun; Zhang, Hongfei et al. (2017) Dose-adjusted plasma concentrations of sublingual buprenorphine are lower during than after pregnancy. Am J Obstet Gynecol 216:64.e1-64.e7
Kalluri, Hari V; Zhang, Hongfei; Caritis, Steve N et al. (2017) A physiologically based pharmacokinetic modelling approach to predict buprenorphine pharmacokinetics following intravenous and sublingual administration. Br J Clin Pharmacol 83:2458-2473
Caritis, Steve N; Bastian, Jaime R; Zhang, Hongfei et al. (2017) An evidence-based recommendation to increase the dosing frequency of buprenorphine during pregnancy. Am J Obstet Gynecol 217:459.e1-459.e6
Bustos, Martha; Venkataramanan, Raman; Caritis, Steve (2017) Nausea and vomiting of pregnancy - What's new? Auton Neurosci 202:62-72
Shaik, Imam H; Bastian, Jaime R; Zhao, Yang et al. (2016) Route of administration and formulation dependent pharmacokinetics of 17-hydroxyprogesterone caproate in rats. Xenobiotica 46:169-74
Lemon, Lara S; Zhang, Hongfei; Hebert, Mary F et al. (2016) Ondansetron Exposure Changes in a Pregnant Woman. Pharmacotherapy 36:e139-41

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