Prostaglandin E2

Overview

Dinoprostone is a naturally occurring prostaglandin E2 (PGE2). It has important effects in labour. It also stimulates osteoblasts to release factors which stimualtes bone resorption by osteoclasts. As a prescription drug it is used as a vaginal suppository, to prepare the cervix for labour and to induce labour.

Indication

For the termination of pregnancy during the second trimester (from the 12th through the 20th gestational week as calculated from the first day of the last normal menstrual period), as well as for evacuation of the uterine contents in the management of missed abortion or intrauterine fetal death up to 28 weeks of gestational age as calculated from the first day of the last normal menstrual period. Also used in the management of nonmetastatic gestational trophoblastic disease (benign hydatidiform mole). Other indications include improving the cervical inducibility (cervical "ripening") in pregnant women at or near term with a medical or obstetrical need for labor induction, and the management of postpartum hemorrhage.

Associated Conditions

Gestational Trophoblastic Neoplasia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Dinoprostone Versus Vaginal Misoprostol for Induction of Labour	2024/08/19	NCT06560515	Not Applicable	Completed	University of Alexandria
Cook´s balloon versus dinoprostone for Labor Induction of term pregnancies with fetal GROWth restriction (COLIGROW study)	2024/04/15	2024-513523-16-00	Phase 3	Recruiting	Hospital Universitario 12 De Octubre
Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy	2023/03/09	NCT05761418	Phase 3	Completed	Beni-Suef University
Dinoprostone Induction vs. Expectant Management After PROM at Term	2022/06/24	NCT05430711	Phase 4	UNKNOWN	University Medical Centre Ljubljana
Gemeprost Versus Dinoprostone in First Trimester Miscarriages	2022/04/22	NCT05342467	Phase 2	Completed	National University of Malaysia
DOuble-BAlloon Versus PROstaglandin E2 for Cervical Ripening in Low Risk Pregnancies	2021/02/10	NCT04747301	Not Applicable	Recruiting	Hanoi Obstetrics and Gynecology Hospital
Labor Induction After Failed Induction With Dinoprostone.	2020/10/22	NCT04597333	Not Applicable	Completed	Rambam Health Care Campus
Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy	2020/08/05	NCT04500496	Not Applicable	UNKNOWN	Aswan University Hospital
Comparison of Two Rhythm of Administration of Prostaglandin Gel for Induction of Labor	2020/06/04	NCT04413890	Phase 2	Completed	University Hospital Center of Martinique
Intravenous Tranexamic Acid Versus Vaginal Dinoprostone in Abdominal Myomectomy	2020/04/22	NCT04357002	Phase 4	UNKNOWN	Cairo University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Prepidil	Pharmacia and Upjohn Company LLC	0009-3359	VAGINAL	0.5 mg in 3 g	12/11/2019
CERVIDIL	Ferring Pharmaceuticals Inc.	55566-2800	VAGINAL	10 mg in 241 mg	1/31/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
PROSTIN E2 VAGINAL TABLET 3 mg	Sanico NV	SIN02520P	TABLET	3 mg	4/17/1989
Cervidil Vaginal Delivery System 10mg	Ferring Controlled Therapeutics Limited	SIN13982P	OTHER	10mg	7/4/2011

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
PROSTIN E2 STERILE SOLN 10MG/ML	N/A	Pfizer Corporation Hong Kong Limited	N/A	N/A	11/20/1980

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CERVIDIL dinoprostone 10 mg pessary sachet	81391	Ferring Pharmaceuticals Pty Ltd	Medicine	A	1/11/2002
PROSTIN E2 VAGINAL GEL 2mg	9984	Pfizer Australia Pty Ltd	Medicine	A	8/27/1991
PROSTIN E2 VAGINAL GEL 1mg	9983	Pfizer Australia Pty Ltd	Medicine	A	8/27/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PROSTIN E2 TABLETS	Pfizer Canada Ulc	00400688	Tablet - Oral	0.5 MG	12/31/1977
PROSTIN E2 VAGINAL GEL	Pfizer Canada Ulc	01919679	Gel - Vaginal	1 MG / 3 G	12/31/1991
CERVIDIL	Ferring Inc	02231047	Insert - Vaginal	10 MG / INSERT	6/10/1997
PROSTIN E2 VAGINAL GEL	Pfizer Canada Ulc	01919687	Gel - Vaginal	2 MG / 3 G	12/31/1991
PREPIDIL GEL	Pfizer Canada Ulc	00860786	Gel - Intracervical	0.5 MG / 2.5 ML	12/31/1990

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
PROSTAGLANDINA E2 PFIZER 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION	Pfizer S.L.	56620	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
PROPESS 10 mg SISTEMA DE LIBERACION VAGINAL	Ferring S.A.	62088	SISTEMA DE LIBERACIÓN VAGINAL	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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