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Also known as 17-alpha-hydroxy-progesterone caproate, Makena®
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 being studied for the prevention of preterm delivery. It is a small molecule being developed by Pediatrix Medical Group, Inc. (ticker: MD). The drug is in Phase 2 clinical development and is not yet approved for commercial use.
17-alpha-hydroxy-progesterone caproate (Makena) is being developed by Pediatrix Medical Group, Inc., which trades under the ticker MD. The company is responsible for the clinical development of 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 the FDA. The Phase 2 trial has been completed.
17-alpha-hydroxy-progesterone caproate (Makena) has been studied in one completed Phase 2 clinical trial, NCT01119963, titled "Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM)." The trial enrolled 152 participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, 17-alpha-hydroxy-progesterone caproate is also known as Makena. Makena is a brand name for the same drug. Both names refer to the same small molecule being developed for preterm delivery.