Drugs / 17-hydroxyprogesterone caproate
17-hydroxyprogesterone caproate
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase not applicable1 trial | ||||||
| — | NCT00120640 | Jul 2005 → ? | — | Yale University | Withdrawn | No outcome recorded Stop: Business |
| Comparator or background therapy5 trials | ||||||
| Phase 1/2 | NCT03292731 Comparator | Feb 2018 → Sep 2021 | — | Steve N. Caritis, MD | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT01050647 Comparator | Feb 2010 → Dec 2015 | pregnancy disorder | Stanford University | Completed | No outcome recorded |
| Phase 2 | NCT04807543 Comparator | Jan 2018 → Oct 2020 | preterm premature rupture of the membranes | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT02913495 Comparator | Sep 2016 → Aug 2021 | — | Thomas Jefferson University | Completed | Missed primary |
| — | NCT00694967 Comparator | Nov 2003 → Dec 2006 | cervix disorder | Lehigh Valley Hospital | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2022-06-14 | Covis Pharma S.à.r.l. | Regulatory Covis Pharma Provides Update on FDA Public Hearing for Makena® covispharma.com ↗
FDA’s announcement of the anticipated hearing date is the latest development following FDA’s August 2021 order granting a hearing on its proposal to withdraw approval of Makena and its five generic versions. |
| 2021-08-19 | Covis Pharma S.à.r.l. | Regulatory Covis Pharma Announces FDA’s Decision to Grant Public Hearing for Only FDA-Approved Treatment to Reduce Preterm Birth in Indicated Patients covispharma.com ↗ |
| 2021-03-26 | Covis Pharma S.à.r.l. | Results EPPPIC Study Reaffirms 17-OHPC for Reducing Early Preterm Birth in High-Risk, Singleton Pregnancies covispharma.com ↗
EPPPIC Study Reaffirms 17-OHPC for Reducing Early Preterm Birth in High-Risk, Singleton Pregnancies |
| 2020-12-14 | Covis Pharma S.à.r.l. | Regulatory AMAG Pharmaceuticals Files Submission in Response To the Food And Drug Administration’s Notice of Opportunity for a Hearing and Proposal To Withdraw Approval of Makena® (hydroxyprogesterone caproate injection) covispharma.com ↗
AMAG Pharmaceuticals Files Submission in Response To the Food And Drug Administration’s Notice of Opportunity for a Hearing and Proposal To Withdraw Approval of Makena® (hydroxyprogesterone caproate injection) |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-06-14 | Covis Pharma S.à.r.l. | Covis Pharma Provides Update on FDA Public Hearing for Makena® covispharma.com ↗ |
| 2021-08-19 | Covis Pharma S.à.r.l. | Covis Pharma Announces FDA’s Decision to Grant Public Hearing for Only FDA-Approved Treatment to Reduce Preterm Birth in Indicated Patients covispharma.com ↗ |
| 2021-03-26 | Covis Pharma S.à.r.l. | EPPPIC Study Reaffirms 17-OHPC for Reducing Early Preterm Birth in High-Risk, Singleton Pregnancies covispharma.com ↗ |
| 2020-12-14 | Covis Pharma S.à.r.l. | AMAG Pharmaceuticals Files Submission in Response To the Food And Drug Administration’s Notice of Opportunity for a Hearing and Proposal To Withdraw Approval of Makena® (hydroxyprogesterone caproate injection) covispharma.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 17-hydroxyprogesterone caproate | “250 mg intramuscular 17-hydroxyprogesterone caproate weekly” PMID 35189093 ↗ Feb 2022 |
| Known as | 17 alpha hydroxprogesterone caproate | “Intramuscular Progesterone (17 alpha hydroxprogesterone caproate)” NCT02913495 ↗ |
| Known as | 17-OHPC | “The study plans to determine the relationship between plasma concentrations of 17-OHPC hydroxyprogesterone caproate (17-OHPC) and the rate of preterm birth.” NCT03292731 ↗ |
| Known as | 17P | “We hypothesized that weekly intramuscular injections of 17 hydroxyprogesterone caproate(17P) will reduce the number spontaneous preterm births prior to 35 weeks gestation when...” NCT00694967 ↗1“17 alpha-hydroxyprogesterone caproate (17P)” NCT00120640 ↗ |
| Known as | hydroxyprogesterone caproate | “The study plans to determine the relationship between plasma concentrations of 17-OHPC hydroxyprogesterone caproate (17-OHPC) and the rate of preterm birth.” NCT03292731 ↗ |
| Route | Intramuscular | “intramuscular injections” NCT00120640 ↗ |