13 completed, 3 terminated, 1 unknown. 7 Phase 3, 4 Phase 2, 3 Phase 1, 3 Phase 4, 2 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Completed 5, Terminated 2 |
| Phase 2 | 4 | Completed 4 |
| Phase 1 | 3 | Completed 3 |
| Phase 4 | 3 | Completed 2, Unknown 1 |
| Not applicable | 2 | Completed 1, Terminated 1 |
Follow 17 alpha-Hydroxyprogesterone Caproate: new trials by email Literature Review of 17 alpha-Hydroxyprogesterone Caproate trials Research Report on 17 alpha-Hydroxyprogesterone Caproate
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Progesterone in Expectantly Managed Early-onset Preeclampsia 17 Hydroxyprogesterone Capronate - Preeclampsia | Phase 4 | Completed | Assiut University | 80 | 2019-12-15 | 2022-05-09 |
| Effect of Progesterone on Latent Phase Prolongation in Patients With Preterm Premature Rupture of Membranes 17-hydroxyprogesterone caproate, Castor Oil - Preterm Premature Rupture of Membrane | Phase 2 | Completed | Ain Shams University | 100 | 2018-01-10 | 2021-03-19 |
| Gonadotropin Releasing Hormone Agonist (GnRHa) Versus Estrogen and Progesterone for Luteal Support in High Responders Synarel, 0.2 Mg/Inh Nasal Spray, Estrofem, Utrogestan - Pregnancy Early, Miscarriage | Phase 4 | Unknown | Assaf-Harofeh Medical Center | 100 | 2017-12-29 | 2021-04-01 |
| 17OHP-C Dosing Among Obese Pregnant Women 17-Hydroxyprogesterone Capronate - Premature Birth, Absorption; Chemicals | Phase 3 | Completed | University of South Florida | 44 | 2017-08-23 | 2022-01-12 |
| Study Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via Needle and Syringe in Healthy Post-menopausal Women Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) - Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal Women | Phase 3 | Terminated | AMAG Pharmaceuticals, Inc. | 60 | 2016-10-07 | 2022-04-21 |
| Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth Vaginal Progesterone, Intramuscular Progesterone (17 alpha hydroxprogesterone caproate) - Premature Birth | Phase 4 | Completed | Thomas Jefferson University | 210 | 2016-09-01 | 2026-02-24 |
| Comparing Bioavailability When Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is Administered as an Intramuscular Manual Injection or as a Subcutaneous Injection Using an Auto-injector in Healthy Post-menopausal Women Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) - Comparing Bioavailability When Makena® is Administered in Healthy Post-menopausal Women | Phase 1 | Completed | AMAG Pharmaceuticals, Inc. | 122 | 2016-09-01 | 2022-04-28 |
| Pharmacokinetic Study of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) and Its Metabolites in Blood Hydroxyprogesterone caproate 250 mg/ml - Pregnancy | Phase 1 | Completed | Lumara Health, Inc. | 30 | 2013-07-01 | 2014-08-18 |
| Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM) 17-alpha-hydroxy-progesterone caproate, Makena®, Castor Oil (Placebo) - Preterm Delivery | Phase 2 / Phase 3 | Completed | Obstetrix Medical Group | 152 | 2011-10-01 | 2018-06-28 |
| Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial. 17-Hydroxyprogesterone Caproate, Caster Oil injections - Pregnancy Complications | Phase 1 / Phase 2 | Completed | Stanford University | 21 | 2010-02-01 | 2019-04-09 |
| Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL, Vehicle - Preterm Birth | Phase 3 | Completed | AMAG Pharmaceuticals, Inc. | 1740 | 2009-10-01 | 2022-06-01 |
| RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix 17 alpha-hydroxyprogesterone caproate, Placebo Oil - Preterm Delivery, Cervical Length | Phase 3 | Terminated | The George Washington University Biostatistics Center | 657 | 2007-04-01 | 2019-07-15 |
| Prevention of Preterm Delivery in Twin Pregnancies by 17 Alpha-hydroxyprogesterone Caproate 17-alpha Hydroxyprogesterone Caproate, Castor oil - Preterm Delivery | Phase 2 | Completed | American University of Beirut Medical Center | 290 | 2006-10-01 | 2013-07-19 |
| Comparing IM vs. Vaginal Progesterone for Pre-term Birth Intramuscular Progesterone, Vaginal Progesterone - Infant, Premature, Premature Birth | Not applicable | Completed | University of Oklahoma | 174 | 2006-10-01 | 2021-05-19 |
| Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in High Risk Pregnancies 17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement, 17 alpha-hydroxy progesterone caproate and Placebo supplement - Preterm Birth | Phase 3 | Completed | The George Washington University Biostatistics Center | 800 | 2005-02-01 | 2019-07-12 |
| Trial of Progesterone in Twins and Triplets to Prevent Preterm Birth (STTARS) 17 alpha-hydroxyprogesterone caproate (17P) - Preterm Birth, Pregnancy | Phase 3 | Completed | The George Washington University Biostatistics Center | 795 | 2004-04-01 | 2019-02-21 |
| A Randomized Trial of Cerclage Versus 17 α-Hydroxyprogesterone Caproate for Treatment of a Short Cervix McDonald cerclage placement, 17 hydroxyprogesterone caproate - Mid Trimester Cervical Shortening | Not applicable | Terminated | Lehigh Valley Hospital | 92 | 2003-11-01 | 2008-06-11 |
Premature Birth (9) · Abortion, Spontaneous (1) · Ovarian Hyperstimulation Syndrome (1) · Pre-Eclampsia (1) · Pregnancy Complications (1) · Preterm Premature Rupture of the Membranes (1)
AMAG Pharmaceuticals, Inc. (3) · The George Washington University Biostatistics Center (3) · Ain Shams University (1) · American University of Beirut Medical Center (1) · Assaf-Harofeh Medical Center (1) · Assiut University (1) · Lehigh Valley Hospital (1) · Lumara Health, Inc. (1) · Obstetrix Medical Group (1) · Stanford University (1) · Thomas Jefferson University (1) · University of Oklahoma (1) · University of South Florida (1)
United States (13) · Egypt (2) · Bulgaria (1) · Canada (1) · Czechia (1) · Hungary (1) · Israel (1) · Italy (1) · Lebanon (1) · Russia (1) · Spain (1) · Ukraine (1)
Menachem Miodovnik, MD (2) · Andrew Combs, MD (1) · Andrew Elimian, MD (1) · Anthony O Odibo, MD (1) · Anwar H Nassar, MD (1) · Dwight Rouse, MD (1) · Elizabeth A Thom, Ph.D. (1) · Elizabeth A Thom, PhD (1) · Julie Krop, MD (1) · Margaret Harper, MD (1) · Menachem Miodovnik, M.D. (1) · Michal Youngster, MD (1) · Neil Singla, MD (1) · Orion Rust, M.D (1) · Robert Birch, PhD (1)
PMID 17671253, PMID 19155896, PMID 19716543, PMID 20093894, PMID 21173653, PMID 21508745, PMID 21620357, PMID 22206581, PMID 23010094, PMID 23635681, PMID 25425377, PMID 27168167, PMID 29191450, PMID 31652479, PMID 35189093
U10HD021410 (2), U10HD027869 (2), U10HD027915 (2), U10HD027917 (2), U10HD034136 (2), U10HD034208 (2), U10HD036801 (2), U10HD040485 (2), U10HD040500 (2), U10HD040512 (2), U10HD040544 (2), U10HD040545 (2), U10HD040560 (2), U10HD027860 (1), U10HD034116 (1)