Hydroxyprogesterone Caproate

history of singleton spontaneous preterm birth, Adenocarcinoma, prophylaxis of preterm birth + 5 more

Treatment

13 FDA approvals

20 Active Studies for Hydroxyprogesterone Caproate

What is Hydroxyprogesterone Caproate

Hydroxyprogesterone caproate

The Generic name of this drug

Treatment Summary

Hydroxyprogesterone caproate is a synthetic steroid hormone used to treat preterm delivery in pregnant women with a history of preterm delivery. The drug was first marketed under the name Delalutin by Squibb in 1956 and was approved by the FDA. It was withdrawn from the market in 1999 but was re-introduced in 2011 under the brand name Makena, sparking controversy over its pricing.

Makena

is the brand name

image of different drug pills on a surface

Hydroxyprogesterone Caproate Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Makena

Hydroxyprogesterone caproate

2011

20

Approved as Treatment by the FDA

Hydroxyprogesterone caproate, otherwise known as Makena, is approved by the FDA for 13 uses including Amenorrhea and Adenocarcinoma .

Amenorrhea

Helps manage Secondary Amenorrhea

Adenocarcinoma

Uterine hemorrhage

Helps manage Abnormal Uterine Bleeding

stage 4 adenocarcinoma of the uterine corpus

stage 3 adenocarcinoma of the uterine corpus

Secondary Amenorrhea

Helps manage Secondary Amenorrhea

Primary Amenorrhoea

Helps manage Primary Amenorrhoea

Premature Births

history of singleton spontaneous preterm birth

Abnormal Uterine Bleeding

Helps manage Abnormal Uterine Bleeding

prophylaxis of preterm birth

Adenocarcinoma

Premature Birth

Effectiveness

How Hydroxyprogesterone Caproate Affects Patients

It is not known exactly how hydroxyprogesterone caproate injections work, but it is thought that they make progesterone in the body interact more with its receptors.

How Hydroxyprogesterone Caproate works in the body

Progesterone helps prevent preterm birth, though we don't know exactly how it works. It is known to be important for carrying a baby to term, likely due to its ability to attach to different receptors in the uterus, ovaries, breasts, and central nervous system. This attachment then helps to regulate gene transcription, and produces an anti-inflammatory effect. This calms the pro-inflammatory state that happens when labor begins, and keeps the uterus relaxed.

When to interrupt dosage

The proposed dose of Hydroxyprogesterone Caproate is contingent upon the determined disorder, such as Uterine hemorrhage, Secondary Amenorrhea and past of singleton unpremeditated preterm birth. The dosage shifts as per the system of introduction (e.g. Liquid - Intramuscular or Injection - Subcutaneous) specified in the table underneath.

Condition

Dosage

Administration

history of singleton spontaneous preterm birth

250.0 mg/mL, , 1250.0 mg/mL

Injection, Injection - Intramuscular, , Intramuscular, Subcutaneous, Injection - Subcutaneous, Liquid - Intramuscular, Liquid

Adenocarcinoma

250.0 mg/mL, , 1250.0 mg/mL

Injection, Injection - Intramuscular, , Intramuscular, Subcutaneous, Injection - Subcutaneous, Liquid - Intramuscular, Liquid

prophylaxis of preterm birth

250.0 mg/mL, , 1250.0 mg/mL

Injection, Injection - Intramuscular, , Intramuscular, Subcutaneous, Injection - Subcutaneous, Liquid - Intramuscular, Liquid

Adenocarcinoma

250.0 mg/mL, , 1250.0 mg/mL

Injection, Injection - Intramuscular, , Intramuscular, Subcutaneous, Injection - Subcutaneous, Liquid - Intramuscular, Liquid

Amenorrhea

250.0 mg/mL, , 1250.0 mg/mL

Injection, Injection - Intramuscular, , Intramuscular, Subcutaneous, Injection - Subcutaneous, Liquid - Intramuscular, Liquid

Uterine hemorrhage

250.0 mg/mL, , 1250.0 mg/mL

Injection, Injection - Intramuscular, , Intramuscular, Subcutaneous, Injection - Subcutaneous, Liquid - Intramuscular, Liquid

Premature Birth

250.0 mg/mL, , 1250.0 mg/mL

Injection, Injection - Intramuscular, , Intramuscular, Subcutaneous, Injection - Subcutaneous, Liquid - Intramuscular, Liquid

Primary Amenorrhoea

250.0 mg/mL, , 1250.0 mg/mL

Injection, Injection - Intramuscular, , Intramuscular, Subcutaneous, Injection - Subcutaneous, Liquid - Intramuscular, Liquid

Warnings

Hydroxyprogesterone Caproate Contraindications

Condition

Risk Level

Notes

Breast Cancer

Do Not Combine

Liver Dysfunction

Do Not Combine

Breast Neoplasms

Do Not Combine

Thromboembolism

Do Not Combine

diagnostic use for pregnancy

Do Not Combine

Abortion, Spontaneous

Do Not Combine

history of hormone-sensitive cancer

Do Not Combine

Vaginal Hemorrhage

Do Not Combine

Thromboembolism

Do Not Combine

Breast

Do Not Combine

Thrombosis

Do Not Combine

history of thrombotic disorder

Do Not Combine

hormone-sensitive cancer

Do Not Combine

There are 20 known major drug interactions with Hydroxyprogesterone Caproate.

Common Hydroxyprogesterone Caproate Drug Interactions

Drug Name

Risk Level

Description

Acenocoumarol

Major

The metabolism of Acenocoumarol can be increased when combined with Hydroxyprogesterone caproate.

Astemizole

Major

The metabolism of Astemizole can be decreased when combined with Hydroxyprogesterone caproate.

Axitinib

Major

The metabolism of Axitinib can be decreased when combined with Hydroxyprogesterone caproate.

Cabazitaxel

Major

The metabolism of Cabazitaxel can be decreased when combined with Hydroxyprogesterone caproate.

Clomipramine

Major

The metabolism of Clomipramine can be increased when combined with Hydroxyprogesterone caproate.

Hydroxyprogesterone Caproate Toxicity & Overdose Risk

Pain at the injection site is the most common side effect of hydroxyprogesterone caproate. Other potential effects include swelling, hives, itching, nausea, lumps, and diarrhea.

image of a doctor in a lab doing drug, clinical research

Hydroxyprogesterone Caproate Novel Uses: Which Conditions Have a Clinical Trial Featuring Hydroxyprogesterone Caproate?

Currently, 29 active trials are analyzing the potential of Hydroxyprogesterone Caproate to ameliorate Adenocarcinoma, Adenocarcinoma and a history of singleton spontaneous preterm birth.

Condition

Clinical Trials

Trial Phases

Premature Birth

25 Actively Recruiting

Not Applicable, Phase 2, Phase 3, Phase 4, Phase 1

history of singleton spontaneous preterm birth

0 Actively Recruiting

Uterine hemorrhage

0 Actively Recruiting

Adenocarcinoma

0 Actively Recruiting

Amenorrhea

0 Actively Recruiting

Adenocarcinoma

0 Actively Recruiting

prophylaxis of preterm birth

0 Actively Recruiting

Primary Amenorrhoea

0 Actively Recruiting

Hydroxyprogesterone Caproate Reviews: What are patients saying about Hydroxyprogesterone Caproate?

4.3

Patient Review

5/15/2013

Hydroxyprogesterone Caproate for Risk Reduction for Recurrent Preterm Birth

I have a history of preterm labor and the pain from my back is unbearable. I've only had 5 shots so far, but I would not recommend this treatment to anyone else. The studies are conflicting and it's inconvenient to have to go to the doctor every week.

3.7

Patient Review

4/14/2008

Hydroxyprogesterone Caproate for Female Hormone Disturbance

I'm using this to help with PTL, but it seems like the more shots I get, the more pain I'm in. My nurse says that's due to scar tissue build-up, but it's keeping me pregnant so far, so I guess it's worth it.

2

Patient Review

5/23/2008

Hydroxyprogesterone Caproate for Female Hormone Disturbance

I've been getting this shot for seven weeks now. I'm not sure if it's working or not, but I'm 23 weeks into my pregnancy and things seem to be going well.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about hydroxyprogesterone caproate

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is hydroxyprogesterone caproate used for?

"Hydroxyprogesterone caproate is an injection of man-made progestin hormone. It is given to pregnant women to help lower the risk of preterm birth."

Answered by AI

How does hydroxyprogesterone work?

"Hydroxyprogesterone is a manmade form of the female hormone progesterone. It's used to lower the risk of premature birth in a woman who's already had a premature baby. Hydroxyprogesterone won't stop premature labor that's already started."

Answered by AI

Why progesterone injection is given during pregnancy?

"Progesterone is a hormone that helps with the growth of the uterus during pregnancy and prevents it from contracting. If you have a short cervix, treatment with vaginal progesterone gel may help prevent premature birth."

Answered by AI

Clinical Trials for Hydroxyprogesterone Caproate

Image of Royal Alexandra Hospital in Edmonton, Canada.

Oxygen Concentration for Premature Birth

No minimum age - 10
All Sexes
Edmonton, Canada

This study is aims to examine the best amount of oxygen to give preterm babies (born between 32 and 35 weeks) right after birth. In the past, doctors used high levels of oxygen, but research has shown that using lower levels might help reduce the risk of death in full-term babies without harming brain development. However, investigators don't know the best oxygen level for babies born a little early (32 to 35 weeks). Some early data suggests that giving lower oxygen levels (FiO2 0.3) may not help babies reach healthy oxygen levels by 5 minutes after birth. This study will compare two oxygen levels-FiO2 0.6 and FiO2 0.3 to see which helps babies breathe better and need less ongoing breathing support. Researchers will study over 1,500 babies in hospitals across Alberta, Canada, to find the safest approach for these babies.

Waitlist Available
Has No Placebo

Royal Alexandra Hospital

Georg Schmolzer

Image of University of North Carolina School of Medicine - Chapel Hill in Chapel Hill, United States.

Prenatal Support Program for Premature Birth

18+
Female
Chapel Hill, NC

The goal of this clinical trial is to learn if a personalized prenatal support program \[(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond, (PTBCARE+)\] works to lower stress and lower the risk of early delivery in pregnant individuals at high-risk for delivering preterm. The main question\[s\] it aims to answer are: * Does the PTBCARE+ patient support program lower patient-reported stress levels during pregnancy? * Does the PTBCARE+ patient support program improve biologic measures of stress during pregnancy? * Does the PTBCARE+ patient support program result in a higher chance of delivering a healthy baby at or close to full term? Researchers will compare people who participate in the PTBCARE+ patient support program to those receive usual care to see if the PTBCARE+ patient support program lowers patient-reported stress, improves biologic measures of stress, and increases the chance of delivering a healthy baby at or close to full term. Participants will be randomly assigned to receive the PTBCARE+ patient support program or usual prenatal care. All participants will be asked to: * complete 2 study visits during pregnancy - including completing electronic surveys, providing a blood and urine sample, measuring the heart rate variability by a clip or the ear or finger, and body composition evaluation using a simple scale-like device. * complete one study visit postpartum that includes completing electronic surveys, and measuring heart rate variability. Blood and urine sample collection and body composition evaluation via InBody scale are optional at the postpartum visit. People who are randomly assigned to receive the PTBCARE+ support program will receive several resources to help them during pregnancy. These things include items such as: * a stress reduction toolkit; * access to an online website that can also be downloaded as a smart phone app; * the option to receive an electronic massage while in clinic, and more. * additional support gifts provided at routine clinical appointments People who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.

Waitlist Available
Has No Placebo

University of North Carolina School of Medicine - Chapel Hill

Tracy Manuck, MD

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Image of Henry Ford Health New Center One in Detroit, United States.

Cervical Length Measurement Timing for Preterm Birth

Any Age
Female
Detroit, MI

The goal of this clinical trial is to determine the optimal timing for measuring cervical length (CL) during fetal anatomy surveys in pregnant individuals. This study focuses on improving the accuracy of cervical length assessments, which are critical for identifying individuals at risk for preterm birth. The main questions it aims to answer are: * Does measuring cervical length at the beginning of the anatomy survey result in a higher proportion of scans meeting the nine CLEAR (Cervical Length Education and Review) criteria compared to measuring at the end of the survey? * Does the use of sepia-filtered ultrasound images improve the proportion of scans meeting the nine CLEAR criteria compared to conventional grayscale images? Researchers will compare two groups of participants randomized to have cervical length measured either at the beginning or at the end of the anatomy survey. Additionally, all participants will undergo cervical length measurements using both grayscale and sepia-filtered ultrasound imaging. Participants will: * Receive a patient information sheet through MyChart explaining the study and standard cervical length screening during anatomy surveys. * Provide verbal consent for a transvaginal ultrasound and study participation. * Be randomized to have their cervical length measured at either the start or end of the fetal survey. * Undergo cervical length measurement using both grayscale and sepia-filtered ultrasound imaging modalities. * This study involves no additional risks beyond those of routine clinical care and aims to enhance clinical practice by identifying optimal methods for cervical length assessment during pregnancy.

Recruiting
Has No Placebo

Henry Ford Health New Center One

Raminder Khangura, MD

Image of University of Washington Medical Center - Montlake in Seattle, United States.

Sodium Awareness for Premature Birth

Any Age
Female
Seattle, WA

SALT is a multi-centre, non-blinded, non-randomized prospective interventional pilot study teaching lactating parents of hospitalized preterm infants how to test their breastmilk sodium (Na) using point-of-care (POC) meters. A drop in Na is a sign of secretory activation in the breast that is associated with adequate short and long-term breast milk volumes in this vulnerable population. Primary Objective: Establish feasibility, acceptance, and time cost of parent-led parent milk Na testing in the first 14 days postpartum Secondary Objective: Further investigate relationships between pumping behaviours, lactation risk factors, daily milk Na and lactation outcomes Exploratory Objective: Explore how POC Na data may be used to modify pumping behaviour and milk volumes

Recruiting
Has No Placebo

University of Washington Medical Center - Montlake (+1 Sites)

Samantha J. Anthony, PhD

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Image of Texas Tech University | Kinesiology and Sport Management Building in Lubbock, United States.

Exercise for Preterm Birth

18 - 35
All Sexes
Lubbock, TX

Young adults born very preterm (32 weeks gestation or earlier) do not respond well to aerobic exercise training, meeting the recommendations set by the Physical Activity Guidelines for Americans, where they do not increase their fitness level (or cardiorespiratory fitness). Thus, they do not receive the health benefits of exercise. Achieving physical fitness through aerobic exercise training is the most cost-effective method for preventing and treating many diseases. Young adults born very preterm also have a higher risk of these conditions. Thus, their inability to respond to increase their fitness is a major problem. One likely explanation for poor exercise trainability and increased heart disease risk in young adults born very preterm is the effect of the early birth on the major energy producers in all our cells: Mitochondria. During late-stage gestation, mitochondria change from relying on sugar as a major fuel source to fat. Unfortunately, individuals born very preterm miss this transition in fuel source reliance, which causes significant stress and damage to mitochondria. Mitochondria are critical for post-natal organ development; thus, it is thought that preterm birth-induced mitochondrial dysfunction is the underlying cause of poor trainability and high disease risk in young adults born very preterm. Indeed, mitochondrial dysfunction is evident in these individuals. To date, there is not a way to help young adults born preterm improve their fitness level. One likely target is in the mitochondria: it's DNA. Mitochondrial DNA helps determine how mitochondria function and can be damaged under stress. Our goal in this proposed work is to determine the role of mitochondrial DNA in mitochondrial dysfunction and its link to their poor trainability. Questions: 1. Are there mitochondrial DNA markers linked to mitochondrial dysfunction and poor exercise trainability in young adults very born preterm? 2. Do mitochondrial DNA in young adults born very preterm respond differently to aerobic exercise training than those born at term? The investigators expect this work will show mitochondrial DNA changes linked to mitochondrial dysfunction and poor trainability, which can be used for future targets to improve health. This work supports AHA mission by helping to identify a marker in individuals born very preterm linked to their higher heart disease risk and death early in life.

Recruiting
Has No Placebo

Texas Tech University | Kinesiology and Sport Management Building

Image of Sunnybrook Health Sciences Center in Toronto, Canada.

CPAP vs NIPPV for Premature Infants

1 - 8
All Sexes
Toronto, Canada

Background: In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to collapse. This support commonly done by CPAP and Non-Invasive Positive Pressure Ventilation (NIPPV) therapy by giving some pressure and oxygen to their lungs through an interface placed on their noses. Both (CPAP and NIPPV) can be used as a support modality for respiratory distress syndrome, apnea of prematurity, and providing breathing support after extubation from the full mechanical breathing support. The CPAP supports the baby's immature lungs by delivering constant pressure to keep their lungs and breathing well supported. Whereas the NIPPV will use constant pressure in the background (similar to CPAP), and on top, it will give extra intermittent puffs at regular intervals to support the baby's breathing. The NIPPV is the most common choice by the clinicians when the traditional CPAP is no longer effective, to avoid the full mechanical breathing support and to protect the developing lungs. Studies suggested that NIPPV is better than the traditional CPAP in reducing the need of the baby to need full mechanical breathing support. This might be because the investigators tend to use lower pressures with CPAP (5-8 cmH2O) compared to relatively higher pressures with NIPPV. More recently, clinicians showed the safety of using equivalent higher CPAP pressures (\>9 cmH2O) to what the investigators use in the NIPPV in preterm babies. One way to measure the support that the investigators are giving to the patient with the different devices is to measure the diaphragm activity, which the investigators call the Edi signal, using a special feeding catheter and a specific machine to measure it. The catheter is placed and used as a routine feeding tube but has sensors at the end to measure this Edi signal. One opening of the tube will be connected to a computer to record the Edi signals. The other opening of the tube will be used for feeding.

Recruiting
Has No Placebo

Sunnybrook Health Sciences Center

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