Dinoprostone
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | PROSTIN E2 | — | 1977-08-23 | fda.gov ↗ |
Trials 42
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00432588 | — | preeclampsia, preterm premature rupture of the membranes | Hormozgan University of Medical Sciences | Unknown | No outcome recorded |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT04413890 | Dec 2019 → Jan 2021 | cervix disorder | University Hospital Center of Martinique | Completed | No outcome recorded |
| Phase 2 | NCT02861079 | Aug → Dec 2017 | cervix disorder | Zeynep Kamil Maternity and Pediatric Research and Training Hospital | Completed | Missed primary |
| Phase 2 | NCT01916291 | Aug 2013 → Aug 2018 | — | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 315 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT04340778 | Apr → Aug 2020 | — | Cairo University | Unknown | No outcome recorded |
| Phase 3 | NCT04301349 | Mar → Jun 2020 | — | Cairo University | Unknown | No outcome recorded |
| Phase 3 | NCT04080323 | Sep 2019 → May 2020 | — | Cairo University | Completed | No outcome recorded |
| Phase 3 | NCT04085757 | Sep → Dec 2019 | — | Cairo University | Completed | Met primary |
| Phase 3 | NCT04080375 | Sep → Nov 2019 | leiomyoma | Cairo University | Unknown | No outcome recorded |
| Phase 3 | NCT03806231 | Aug → Dec 2019 | — | Intermountain Health Care, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03686085 | Sep 2018 → Mar 2019 | uterine inflammatory disease | Cairo University | Completed | No outcome recorded |
| Phase 3 | NCT05761418 | Mar 2018 → Feb 2023 | leiomyoma | Beni-Suef University | Completed | No outcome recorded |
| Phase 3 | NCT03067727 | Apr 2017 → Aug 2018 | cervix disorder | Ferring Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03067597 | Feb 2017 → Feb 2018 | cervix disorder | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02907060 | Jan 2017 → Dec 2018 | — | University Hospital, Tours | Completed | Missed primary |
| Phase 3 | NCT02888041 | Dec 2016 → Apr 2022 | cervix disorder, pregnancy disorder | University Hospital, Limoges | Terminated | No outcome recorded |
| Phase 3 | NCT02684305 | Apr 2016 → Apr 2018 | — | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT01099280 | Nov 2009 → Nov 2010 | preterm premature rupture of the membranes | Erzincan Military Hospital | Completed | No outcome recorded |
| Phase 3 | NCT03489928 | Apr 1999 → Dec 2000 | — | David Young | Completed | No outcome recorded |
| Phase 413 trials · 1 met primary | ||||||
| Phase 4 | NCT06803992 | Apr 2025 → Jan 2027 expected | — | HaEmek Medical Center, Israel | Recruiting | No outcome recorded |
| Phase 4 | NCT05430711 | Jun 2022 → Jun 2023 | preterm premature rupture of the membranes | University Medical Centre Ljubljana | Unknown | No outcome recorded |
| Phase 4 | NCT04079140 | Sep → Nov 2019 | — | Cairo University | Completed | No outcome recorded |
| Phase 4 | NCT04080336 | Sep → Dec 2019 | — | Cairo University | Completed | No outcome recorded |
| Phase 4 | NCT04080349 | Sep → Nov 2019 | — | Cairo University | Unknown | No outcome recorded |
| Phase 4 | NCT04046302 | Aug 2019 → Jan 2020 | — | Cairo University | Completed | Met primary |
| Phase 4 | NCT04044079 | Aug 2019 → Jan 2020 | — | Cairo University | Completed | No outcome recorded |
| Phase 4 | NCT04045548 | Aug 2019 → Jan 2020 | — | Cairo University | Completed | No outcome recorded |
| Phase 4 | NCT04042974 | Aug → Nov 2019 | — | Cairo University | Unknown | No outcome recorded |
| Phase 4 | NCT03683914 | Sep 2018 → Jan 2019 | — | Cairo University | Completed | No outcome recorded |
| Phase 4 | NCT01620814 | Jul → Aug 2012 | cervix disorder | Zekai Tahir Burak Women's Health Research and Education Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01190163 | Jun 2010 → Jan 2012 | — | Ferring Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00843362 | Dec 2006 → Mar 2008 | cervix disorder | University of Brescia | Completed | No outcome recorded |
| Phase not applicable10 trials | ||||||
| — | NCT07366359 | Feb 2026 → Dec 2027 expected | cervix disorder, preterm premature rupture of the membranes | National Hospital of Obstetrics and Gynecology | Recruiting | No outcome recorded |
| — | NCT06560515 | Aug 2022 → Jul 2023 | — | University of Alexandria | Completed | No outcome recorded |
| — | NCT04747301 | Aug 2021 → Aug 2025 | — | Hanoi Obstetrics and Gynecology Hospital | Unknown | No outcome recorded |
| — | NCT04500509 | Sep 2020 → Aug 2021 | female infertility | Aswan University Hospital | Completed | No outcome recorded |
| — | NCT03111316 | Apr 2017 → Jan 2018 | cervix disorder | University of Oklahoma | Completed | No outcome recorded |
| — | NCT03033264 | Jan 2017 → Jul 2020 | — | Rambam Health Care Campus | Completed | No outcome recorded |
| — | NCT02825641 | Aug 2016 → Nov 2021 | toxic or drug-related embryofetopathy | Rambam Health Care Campus | Completed | No outcome recorded |
| — | NCT01962831 | Oct 2013 → Jun 2016 | obesity disorder, pregnancy disorder | Saskatchewan Health Authority - Regina Area | Completed | No outcome recorded |
| — | NCT00385229 | Sep 2002 → Dec 2003 | perinatal disease | St. Olavs Hospital | Completed | No outcome recorded |
| — | NCT00504465 | May 2002 → Apr 2007 | cervix disorder | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Comparator or background therapy44 trials | ||||||
| Phase 2 | NCT05342467 Comparator | Nov 2022 → Oct 2024 | pregnancy disorder with abortive outcome | National University of Malaysia | Completed | No outcome recorded |
| Phase 2 | NCT02956785 Comparator | Jan 2017 → Nov 2022 | — | South Warwickshire NHS Foundation Trust | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03016442 Comparator | Nov 2016 → Apr 2017 | — | Kanuni Sultan Suleyman Training and Research Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT01765881 Comparator | Sep 2012 → Sep 2015 | uterine disorder | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 2/3 | NCT03320187 Background | Dec 2016 → Sep 2017 | indomethacin embryofetopathy | Ain Shams Maternity Hospital | Completed | No outcome recorded |
| Phase 3 | NCT05774236 Comparator | Mar 2023 → May 2025 | fetal growth restriction | Hospital Universitario 12 de Octubre | Completed | No outcome recorded |
| Phase 3 | NCT04949633 Comparator | Sep 2021 → Sep 2026 overdue | cervix disorder | University Hospital, Tours | Recruiting | No outcome recorded |
| Phase 3 | NCT03001661 Comparator | Dec 2017 → Feb 2021 | indomethacin embryofetopathy | Birmingham Women's NHS Foundation Trust | Completed | No outcome recorded |
| Phase 3 | NCT02036437 Comparator | Sep 2013 → Sep 2014 | indomethacin embryofetopathy | Ain Shams University | Unknown | No outcome recorded |
| Phase 3 | NCT01635439 Comparator | Dec 2010 → Nov 2011 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 3 | NCT01127581 Comparator | Sep 2010 → Mar 2012 | cervix disorder | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00308711 Comparator | Apr 2006 → Aug 2007 | cervix disorder | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00602095 Comparator | Dec 2004 → Mar 2007 | pregnancy disorder | Karolinska University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06794385 Comparator | Jan → Sep 2025 overdue | — | University Medical Centre Ljubljana | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04357002 Comparator | Apr → Oct 2020 | leiomyoma | Cairo University | Unknown | No outcome recorded |
| Phase 4 | NCT04339361 Comparator | Apr → Aug 2020 | — | Cairo University | Unknown | No outcome recorded |
| Phase 4 | NCT04280874 Comparator | Dec 2018 → Jul 2020 | indomethacin embryofetopathy | Clinical Hospital Merkur | Completed | No outcome recorded |
| Phase 4 | NCT03310333 Comparator | Feb 2018 → Apr 2020 | pregnancy disorder | University Hospital, Clermont-Ferrand | Unknown | No outcome recorded |
| Phase 4 | NCT03199820 Comparator | Sep 2017 → Jan 2019 | obstetric disorder | St George's, University of London | Unknown | No outcome recorded |
| Phase 4 | NCT02902653 Comparator | Sep 2016 → Sep 2020 | — | Oihane Lapuente Ocamica | Unknown | No outcome recorded |
| Phase 4 | NCT02620215 Comparator | Nov 2015 → Dec 2017 | pregnancy disorder | KK Women's and Children's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03744364 Comparator | Jun 2014 → Oct 2017 | cervix disorder, pregnancy disorder | Hospital Miguel Servet | Completed | No outcome recorded |
| Phase 4 | NCT01720394 Comparator | Nov 2013 → Jul 2019 | cervix disorder | Medical University of Graz | Unknown | No outcome recorded |
| Phase 4 | NCT01170819 Comparator | Jun 2010 → Sep 2011 | cervix disorder | University of Insubria | Completed | No outcome recorded |
| — | NCT07559812 Comparator | Oct 2025 → Apr 2026 overdue | cervix disorder, pregnancy disorder | Mayo Hospital Lahore | Active not recruiting | No outcome recorded |
| — | NCT06909721 Comparator | Jun 2023 → Jun 2024 | — | Al-Azhar University | Completed | No outcome recorded |
| — | NCT05622968 Comparator | Jan 2023 → Sep 2024 | pregnancy disorder | Hospital Kemaman | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT04597333 Comparator | Oct 2020 → Nov 2021 | indomethacin embryofetopathy | Rambam Health Care Campus | Completed | No outcome recorded |
| — | NCT04500496 Comparator | Sep 2020 → Dec 2021 | — | Aswan University Hospital | Unknown | No outcome recorded |
| — | NCT04505943 Comparator | Sep 2020 → Jul 2021 | uterine inflammatory disease | Aswan University Hospital | Unknown | No outcome recorded |
| — | NCT03675802 Comparator | Sep 2018 → Mar 2019 | female reproductive system disorder | Aljazeera Hospital | Unknown | No outcome recorded |
| — | NCT03928600 Comparator | Feb 2018 → Jan 2020 | cervix disorder | Centro Hospitalar De São João, E.P.E. | Completed | No outcome recorded |
| — | NCT02993432 Comparator | Dec 2016 → Dec 2019 | cervix disorder | Sunnybrook Health Sciences Centre | Unknown | No outcome recorded |
| — | NCT02815865 Comparator | Aug 2016 → Feb 2018 | pregnancy disorder with abortive outcome | Kaplan Medical Center | Unknown | No outcome recorded |
| — | NCT02649920 Comparator | Jun → Nov 2016 | — | Centre Hospitalier Departemental Vendee | Terminated | No outcome recorded |
| — | NCT02618096 Comparator | Oct 2015 → Oct 2018 | — | Seoul National University Hospital | Completed | No outcome recorded |
| — | NCT02416583 Comparator | Apr 2015 → Jul 2018 | — | Seoul National University Hospital | Completed | No outcome recorded |
| — | NCT02393144 Background | Feb 2015 → Jan 2017 | pregnancy disorder | Ankara University | Unknown | No outcome recorded |
| — | NCT02168881 Comparator | May 2014 → Jan 2016 | — | Ain Shams University | Unknown | No outcome recorded |
| — | NCT01792375 Comparator | Feb 2013 → Feb 2018 | — | Seoul National University Hospital | Completed | No outcome recorded |
| — | NCT01596296 Comparator | May 2012 → Oct 2017 | — | Seoul National University Hospital | Completed | No outcome recorded |
| — | NCT01384812 Comparator | Sep 2010 → Jul 2011 | migraine disorder | Troels Wienecke | Completed | No outcome recorded |
| — | NCT01390233 Comparator | Jul 2010 → Feb 2013 | — | University of South Carolina | Completed | No outcome recorded |
| — | NCT01402050 Comparator | Jun 2010 → Nov 2014 | — | Pediatrix | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2020-01-23 | Ferring Pharmaceuticals | Regulatory Ferring’s Propess® is the first pharmacological treatment for cervical ripening to be approved in Japan for over 20 years ferring.com ↗
Ferring Pharmaceuticals today announced that Propess ® (dinoprostone) has been approved by the Minister of Health, Labour and Welfare (MHLW) in Japan for initiation of cervical ripening in patients at term (from 37 completed weeks of gestation). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-04-15 | Khondrion BV | Khondrion highlights potential role of inflammatory lipid modulator prostaglandin E2 in COVID-19 disease khondrion.com ↗ |
| 2020-01-23 | Ferring Pharmaceuticals | Ferring’s Propess® is the first pharmacological treatment for cervical ripening to be approved in Japan for over 20 years ferring.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 88 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dinoprostone | “Insertion of the prostaglandin (Prostin (1mg dinoprostone vaginal gel) or Cervidil (10mg vaginal slow release insert)) of the clinicians choice into the vagina for the purpose...” NCT02993432 ↗84“Dinoprostone, a synthetic analog of prostaglandin E2 (PGE2), is another widely used agent, particularly in settings where controlled release and fewer side effects are desired.” NCT06909721 ↗ “Prostin E2 vaginal tablets contain the active ingredient dinoprostone, which is a naturally occuring female hormone also known as prostaglandin E2.” NCT02620215 ↗ “2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.” NCT04505943 ↗ “Patients with a Bishop score of ≤6 requiring labor induction at term received either a double-balloon catheter or a dinoprostone vaginal insert.” PMID 25408273 ↗ Nov 2014 “Dinoprostone(propess) is commonly used for induction of labor in the pregnant women who has intact membrane after 38weeks of gestational age.” NCT01916291 ↗ “The form used in the study is Propess (Ferring pharmaceuticals) containing 10mg of dinoprostone (prostaglandin E2).” NCT02907060 ↗ “They were randomised to cervical ripening balloon catheter (CRB) or vaginal dinoprostone (Propess).” PMID 32821419 ↗ Aug 2020 “slow-release vaginal dinoprostone; oral misoprostol 25 µg; dinoprostone vaginal gel 2 mg” PMID 37068892 ↗ Apr 2023 “Pre-induction cervical ripening using dinoprostone gel in the vagina.” NCT01390233 ↗ “vaginal insert slow release of dinoprostone 10 mg (Propess)” NCT02684305 ↗ |
| Known as | Cervidil | “Dinoprostone vaginal insert (Cervidil)” NCT00308711 ↗ |
| Known as | Dinoprostone (Propess) | “Dinoprostone (Propess)” NCT07366359 ↗ |
| Known as | DVI | “Women enrolled into the Phase III trial, EXPEDITE (clinical trial registration: NCT01127581), had labour induced with either a misoprostol or dinoprostone vaginal insert (MVI or DVI).” PMID 25758619 ↗ Mar 2015 |
| Known as | PGE2 | “Propess (Controlled release dinoprostone, PGE2, pessary)” NCT01635439 ↗ |
| Known as | Prepidil | “intracervical dinoprostone gel (Prepidil)” NCT00504465 ↗ |
| Known as | Prepidil gel | “The Food and Drug Administration of the United States (FDA) has approved the use of Prepidil gel (prostaglandin E2) for pre-induction cervical ripening18,19.” NCT01390233 ↗ |
| Known as | Propess | “Vaginal slow releasing system of dinoprostone PROPESS® which is inserted in the vagina, against the cervix and left in place during 24 hours.” NCT04949633 ↗10“Dinoprostone(propess) is commonly used for induction of labor in the pregnant women who has intact membrane after 38weeks of gestational age.” NCT01916291 ↗ “The form used in the study is Propess (Ferring pharmaceuticals) containing 10mg of dinoprostone (prostaglandin E2).” NCT02907060 ↗ “Propess, (Dinoprostone 10mg), Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria” NCT01720394 ↗ “a 10-mg vaginal dinoprostone insert (Propess) is placed for cervical ripening” NCT07366359 ↗ “first intravaginal delivery device of Dinoprostone (Propess® 10 mg)” NCT02888041 ↗ “vaginal insert slow release of dinoprostone 10 mg (Propess)” NCT02684305 ↗ “Propess (Controlled release dinoprostone, PGE2, pessary)” NCT01635439 ↗ “Dinoprostone 10mg (Propess)” NCT04747301 ↗ “Propess® (dinoprostone)” NCT03310333 ↗ |
| Known as | prostaglandin E2 | “Vaginal delivery system containing 10 mg dinoprostone (Prostaglandin E2) dispersed throughout its matrix and releasing approximately 0.3 mg/hour dinoprostone over a 24-hour period.” NCT05774236 ↗3“The Food and Drug Administration of the United States (FDA) has approved the use of Prepidil gel (prostaglandin E2) for pre-induction cervical ripening18,19.” NCT01390233 ↗ “Prostin E2 vaginal tablets contain the active ingredient dinoprostone, which is a naturally occuring female hormone also known as prostaglandin E2.” NCT02620215 ↗ “dinoprostone (prostaglandin E2) was introduced in 1995” NCT01635439 ↗ |
| Known as | prostin E2 | “1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.” NCT04044079 ↗10“1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.” NCT04042974 ↗ “1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.” NCT04500496 ↗ “1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) self-inserted by the patient 12 hours before IUD insertion.” NCT04079140 ↗ “1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.” NCT04080336 ↗ “1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 6 hours before IUD insertion.” NCT04045548 ↗ “1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium)” NCT03683914 ↗ “1 vaginal tablet of dinoprostone (3mg) (prostin® E2” NCT04046302 ↗ “1 vaginal tablet of dinoprostone (3mg) (prostin® E2” NCT04080349 ↗ “1 vaginal tablet of dinoprostone (3mg) (prostin® E2” NCT03686085 ↗ “Prostin E2 (Dinoprostone vaginal Tablet)” NCT01635439 ↗ |
| Known as | PROSTINE | “Vaginal gel of dinoprostone (2 mg PROSTINE®) every 6 hours, maximum dose of 6 mg.” NCT04949633 ↗ |
| Modality | Other / unclassified | “prostaglandin dinoprostone” NCT00602095 ↗ |
| Route | Other | “dinoprostone vaginal insert (Cervidil)” NCT00504465 ↗ |