Clinical Trials

Numerous clinical trials spanning early phase 1 through Phase 4, along with non-applicable designations, evaluate Prostaglandin E2 and its signaling pathways across diverse indications. Supported by sponsors such as Zeynep Kamil Maternity and Pediatric Research and Training Hospital, Ataturk University, and the University of Oklahoma, these studies reflect operational statuses ranging from active recruitment and completion to suspension, termination, or withdrawal. Investigated conditions include obstetric applications like cervical ripening and labor induction, oncological malignancies such as colorectal and endometrial carcinomas, and various ocular or inflammatory disorders.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06591247 RECRUITING
Labor, Induced; Cervical Ripening; Balloon Induction; Membrane Stripping; Pregnancy Related; Induction of Birth
Meir Medical Center
 2024-08-07
NCT07733700 NOT_YET_RECRUITING
Asymptomatic Apical Periodontitis; Endodontic Retreatment; Cryotherapy
Alanya Alaaddin Keykubat University
 2026-08-01
NCT06803992 RECRUITING
Induction of Labor
HaEmek Medical Center, Israel
 2025-04-06 PHASE4
NCT07802041 ENROLLING_BY_INVITATION
Premature Rupture of Membranes (PROM)
Pakistan Institute of Medical Sciences
 2026-05-01
NCT07559812 ACTIVE_NOT_RECRUITING
Labor, Induced; Term Pregnancy; Cervical Ripening
Mayo Hospital Lahore
 2025-10-29
NCT04505566 COMPLETED
Diabetic Retinopathy
Stephen J. Kim, MD
 2020-11-09 PHASE1
NCT07261332 COMPLETED
Prelabor Rupture of Membranes; Labor (Obstetrics)--Complications; Induction of Labor
Laiba Qamar
 2025-05-10
NCT06653881 COMPLETED
Anterior Teeth Alignment Efficiency; Pain Perception; PGE2 Biomarker and Their Correlation
Postgraduate Institute of Dental Sciences Rohtak
 2024-06-14
NCT04780269 SUSPENDED
Labor Induction; Induced Delivery
Guangzhou Women and Children's Medical Center
 2023-12 PHASE4
NCT06604598 COMPLETED
Percutaneous Nephrolithotomy (PCNL); Postoperative Pain
Universitas Jenderal Soedirman
 2024-10-08 PHASE4
NCT05622968 TERMINATED
Pregnancy Related; Induction of Labor Affected Fetus / Newborn
Hospital Kemaman
 2023-01-01
NCT06629545 COMPLETED
Apical Periodontitis; Inflammatory Markers
Istanbul Medipol University Hospital
 2023-08-02
NCT06129604 Recruiting
Colorectal Carcinoma (CRC)|Endometrial Carcinoma (EC)
University of Oklahoma
 2024-04-03 Phase 2
NCT06307678 Completed
Periapical; Infection
Ataturk University
 2023-07-07 Not Applicable
NCT07447349 COMPLETED
Gingivitis
Universitas Airlangga
 2023-01-01
NCT06190132 Completed
Uremic Pruritus in Hemodialysis Patients
Ain Shams University
 2023-04-01 Not Applicable
NCT04743297 UNKNOWN
Premature Rupture of Membranes at Term; Induction of Labour
University Medical Centre Maribor
 2021-03 PHASE4
NCT05100264 COMPLETED
Labor, Induced; Induced; Birth
Alexandra Hospital, Athens, Greece
 2021-10-29
NCT05454059 COMPLETED
Periodontitis; Type 2 Diabetes
Ondokuz Mayıs University
 2020-10-22
NCT06145685 COMPLETED
Periodontal Diseases; Smoking Cessation
October 6 University
 2021-01-01
NCT04280874 COMPLETED
Induction of Labor Affected Fetus / Newborn; Prostaglandins Causing Adverse Effects in Therapeutic Use
Clinical Hospital Merkur
 2018-12-10 PHASE4
NCT04009070 COMPLETED
Pain; Acupuncture
Kahramanmaras Sutcu Imam University
 2019-08-15
NCT03806231 TERMINATED
Induction of Labor Affected Fetus / Newborn
Intermountain Health Care, Inc.
 2019-08-07 PHASE3
NCT03629548 COMPLETED
Induced Vaginal Delivery
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
 2018-08-15
NCT03744078 UNKNOWN
Preterm Premature Rupture of Fetal Membranes; Induction of Labor Affected Fetus / Newborn
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
 2018-04-15
NCT02078102 COMPLETED
Multiple Myeloma; Non-Hodgkin's Lymphoma
Sherif S. Farag
 2014-03-11 PHASE2
NCT03597867 COMPLETED
Ocular Inflammation
University of Trieste
 2018-04-25 PHASE3
NCT03390400 UNKNOWN
Age Related Cataracts
Rupert Menapace
 2017-05-29
NCT02861079 COMPLETED
Unfavorable Cervix, Cervical Ripening
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
 2017-08-25 PHASE2
NCT02801227 UNKNOWN
Premature Rupture of Fetal Membranes
Shaare Zedek Medical Center
 2016-09 PHASE4
NCT02486679 UNKNOWN
Labor, Induced
Wolfson Medical Center
 2015-07 PHASE4
NCT02856724 COMPLETED
Early Amniotomy, Unfavorable Cervix
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
 2016-08 PHASE2
NCT02685085 UNKNOWN
Induced Labor
Woman's Health University Hospital, Egypt
 2016-02 PHASE2
NCT02829333 COMPLETED
Uterine Leiomyomas
General Hospital of Ningxia Medical University
 2015-05
NCT01796951 COMPLETED
Tobacco Use Disorder; Smoking
Vanderbilt University
 2013-02 EARLY_PHASE1
NCT02681679 COMPLETED
Cataract
Sun Yat-sen University
 2014-10
NCT00496548 COMPLETED
Crohn's Disease
Vanderbilt University Medical Center
 2007-08
NCT01499069 COMPLETED
Overactive Bladder
Samsung Medical Center
 2010-02
NCT01765881 COMPLETED
Delivery Uterine
University Hospital, Toulouse
 2012-09 PHASE2
NCT03111602 COMPLETED
Pregnancy Complications
Instituto de Cardiologia do Rio Grande do Sul
 2011-05
NCT02695563 COMPLETED
Pregnancy
Università degli Studi di Ferrara
 2014-01 PHASE2
NCT02361645 COMPLETED
Vitreous Inflammation
Università degli Studi di Brescia
 2014-03 PHASE3
NCT02567617 COMPLETED
Inflammatory Disorder of the Cardiovascular System
Instituto de Cardiologia do Rio Grande do Sul
 2014-05 PHASE2
NCT01527838 COMPLETED
Non-Hodgkin's Lymphoma (NHL); Hodgkin's Disease; Chronic Lymphocytic Leukemia (CLL); Acute Myelogenous Leukemia (AML); Acute Lymphoblastic Leukemia (ALL)
Fate Therapeutics
 2012-01 PHASE1
NCT00355303 COMPLETED
Premature Rupture of Membranes at Term
Nilratan Sircar Medical College
 2006-08 PHASE4
NCT02154932 COMPLETED
Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy
Mansoura University
 2011-01 PHASE4
NCT01329562 COMPLETED
Menstrual Migraine
Cady, Roger, M.D.
 2011-05 PHASE4
NCT01170819 COMPLETED
Cervical Ripening; Labor Induction
Università degli Studi dell'Insubria
 2010-06 PHASE4
NCT01384812 COMPLETED
"Migraine-like" Headache
Troels Wienecke
 2010-09
NCT01247376 COMPLETED
Knee Arthroscopy; Meniscus; Inflammation; Hydrops; Cooling
Karolinska Institutet
 2008-01
NCT00957983 COMPLETED
Headache, Migraine
Danish Headache Center
 2009-08 PHASE1; PHASE2
NCT01021761 COMPLETED
Cataracts
Frank A. Bucci, Jr., M.D.
 2009-10 PHASE4
NCT00355966 COMPLETED
Premature Rupture of Membranes at Term
Nilratan Sircar Medical College
 2006-08 PHASE4
NCT00469690 COMPLETED
Cataract
Innovative Medical
 2007-05 PHASE4
NCT00409396 COMPLETED
Ulcerative Colitis
Vanderbilt University
 2006-11
NCT01255839 COMPLETED
Induction Time; Apgar Score; Admission to Neonatal Unit; Vaginal Delivery; Caesarean Section
Glostrup University Hospital, Copenhagen
 2002-12 PHASE4
NCT00545194 WITHDRAWN
Cervical Ripening; Labor, Induced
Institut National de la Santé Et de la Recherche Médicale, France
 2002-01 PHASE3
NCT00637988 COMPLETED
Barrett's Esophagus
AstraZeneca
 2002-04 PHASE4
NCT00347503 COMPLETED
Cataract
Innovative Medical
 PHASE4
NCT00374530 COMPLETED
Headache; Migraine
Danish Headache Center
 2006-08

(data from https://clinicaltrials.gov, updated on 2026-04-15)

Check the Prostaglandin E2 (PGE2) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Prostaglandin E2 binds to specific G-protein-coupled E-prostanoid receptors, modulating intracellular cyclic AMP production and calcium mobilization to induce uterine smooth muscle contraction and tissue softening. This receptor-mediated signaling drives tissue remodeling and contractility, providing the physiological mechanism underlying its clinical utilization for cervical ripening and labor induction evaluated in obstetric trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.