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17-alpha-hydroxy-progesterone caproate, Makena · 1 trial · 1 indication
Gestational age is measured in weeks, from the first day of the woman's last menstrual cycle to the date the baby was born.
| Arm | Type | Description |
|---|---|---|
| 17-alpha hydroxyprogesterone caproate, Makena® | ACTIVE_COMPARATOR | 250 mg of 17P, Makena® intramuscular (IM) weekly. |
| Placebo | PLACEBO_COMPARATOR | Castor Oil (Placebo)intramuscular (IM) weekly |
| Name | Type | Description |
|---|---|---|
| 17-alpha-hydroxy-progesterone caproate, Makena® | DRUG | Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first. |
| Castor Oil (Placebo) | DRUG | IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first. |
Inclusion Criteria: 1. Participant is 18 years old or older 2. Gestational Age (GA) 23w0d and 30w6d @ time of enrollment 3. Singleton pregnancy 4. PROM defined as either (a) or (b) or (c) below (a) Documentation of vaginal leakage of indigo carmine dye instilled via amniocentesis (b) Positive Amnis...
17-alpha-hydroxy-progesterone caproate, also known as Makena, is used for preterm delivery. It is a small molecule being studied to prolong pregnancy in women with preterm rupture of the membranes (PROM). The drug is currently in Phase 2 clinical development and is not yet approved.
The molecular target of 17-alpha-hydroxy-progesterone caproate (Makena) is not specified. It is a small molecule being investigated for its potential to prevent preterm delivery, but its specific mechanism of action has not been disclosed.
17-alpha-hydroxy-progesterone caproate (Makena) is being developed by Pediatrix Medical Group, Inc., which trades under the ticker MD. The company is conducting clinical trials to evaluate the drug for preterm delivery.
17-alpha-hydroxy-progesterone caproate (Makena) is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, with no active trials currently ongoing.
17-alpha-hydroxy-progesterone caproate (Makena) has one completed clinical trial, NCT01119963, titled "Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM)." This Phase 2, randomized, double-blind, placebo-controlled study enrolled 152 participants in the United States.
Yes, 17-alpha-hydroxy-progesterone caproate is the same as Makena. Makena is the brand name for the drug, which is being studied for preterm delivery. The drug is also referred to as 17P in clinical trial literature.