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Also known as 17 alpha hydroxyprogesterone Caproate, 17P, 17Pc, 17HP, 170HP, 170HPC, Progesterone, 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 preterm delivery, specifically for prolongation of pregnancy in women with preterm rupture of the membranes. It is a small molecule developed by Pediatrix Medical Group, Inc. (ticker MD) and is in Phase 2 clinical development.
Makena, or 17-alpha-hydroxy-progesterone caproate, is being developed by Pediatrix Medical Group, Inc., which trades under the ticker MD. The company is the sponsor of the clinical program evaluating the drug in women with preterm rupture of the membranes.
17-alpha-hydroxy-progesterone caproate is in Phase 2 clinical development. It is an investigational drug and is not approved. The Phase 2 trial has been completed, and there are currently no active trials of this drug listed.
Yes, Makena is a brand name for 17-alpha-hydroxy-progesterone caproate. The two names refer to the same small molecule drug, which is being studied for preterm delivery in women with preterm rupture of the membranes.
17-alpha-hydroxy-progesterone caproate has been evaluated in one completed Phase 2 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.
The Phase 2 study of 17-alpha-hydroxy-progesterone caproate, NCT01119963, was a randomized, double-blind, placebo-controlled trial. It enrolled 152 women aged 18 years and older in the United States and evaluated the drug for prolongation of pregnancy in women with preterm rupture of the membranes.