Track topics on Twitter Track topics that are important to you
This study will compare the plasma concentration x time curve or Area Under the Curve (AUC) and the side effects reported with 250 mg intramuscular (IM) and 275 mg subcutaneous (SC) injections of 17-hydroxyprogesterone caproate (17-OHPC).
17-hydroxyprogesterone caproate (17-OHPC) is used in women with a prior preterm birth (PTB) as it reduces recurrences by a third. The drug is administered intramuscularly (IM) but that creates discomfort and in many instances requires repeated office visits as the drug is administered weekly from 16-20 weeks until 36 weeks or delivery. AMAG Pharmaceuticals obtained FDA approval to administer the drug subcutaneously (SC) based on demonstration of bioequivalence of a dose of 275 mg SC to a dose of 250 mg IM. That bioequivalence study was performed in postmenopausal women who received a single dose. This study will be performed in pregnant women with repeated injections both to demonstrate that equivalent exposure is seen and to assess the side effects and acceptance of each route of administration.
A pharmacokinetic (PK) study will be performed after participants have reached steady state (after 9 injections). Participants will receive their injections from research personnel up until the time of completion of the PK study. Home injections will be an option for all participants after the PK study is completed.
17-Hydroxyprogesterone Caproate 250 mg IM Dose, 17-Hydroxyprogesterone Caproate 275 mg SC Dose
University of Pittsburgh-Magee Womens Hospital
Not yet recruiting
University of Pittsburgh
Published on BioPortfolio: 2019-12-06T00:24:49-0500
The goal of our research will be to determine the effectiveness of 17 alpha-hydroxyprogesterone caproate (17P) in the treatment of preterm delivery. Treatment with progesterone is emergin...
Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous studies showed that administration of progesterone to pregnant women at high risk, decrease spontan...
We hypothesized that weekly intramuscular injections of 17 hydroxyprogesterone caproate(17P) will reduce the number spontaneous preterm births prior to 35 weeks gestation when compared to ...
As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical...
Preterm birth is the leading cause of neonatal death and a significant cause of life long disability and health problems. It has been shown that the drug 17-hydroxyprogesterone caproate ca...
This article assesses the effect of weekly intramuscular 17α-hydroxyprogesterone caproate (17P) on midtrimester cervical length (CL) in patients with prior spontaneous preterm birth.
To assess provider practice patterns on type of progesterone prescribed and barriers specific to 17 α-hydroxyprogesterone caproate utilization for preterm birth prevention.
Preterm delivery remains the most significant contributor to perinatal mortality and morbidity. Progestogen supplementation is now standard care for preterm birth prevention in women with a singleton ...
Comparison of daily vaginal progesterone gel plus weekly intramuscular progesterone with daily intramuscular progesterone for luteal phase support in single, autologous euploid frozen-thawed embryo transfers.
To compare outcomes between daily intramuscular progesterone (IMP) and daily vaginal progesterone (VP) gel plus weekly intramuscular hydroxyprogesterone caproate (IMHPC) for luteal phase support (LPS)...
Viral hepatitis is increasingly being recognized as a public health problem in India with 96% of all hepatitis mortality attributed to hepatitis B and C combined. It has been recognized that hepatitis...
The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.
A treatment schedule in which the total dose of radiation is divided into large doses.
The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity. (from Lewis Dictionary of Toxicology, 1st ed)
Administration of the total dose of radiation (RADIATION DOSAGE) in parts, at timed intervals.
The ratio of the dose that produces toxicity to the dose that produces a clinically desired or effective response.
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells. In vertebrates, it is composed of blo...
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...