CLINICAL TRIALS PROFILE FOR DINOPROSTONE

All Clinical Trials for dinoprostone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00140114 ↗	Sublingual Versus Vaginal Misoprostol for Labor Induction at Term	Completed	American University of Beirut Medical Center	Phase 3	2004-01-01	Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the United States since 1988 as a gastric cytoprotective agent. In contradistinction to prostaglandin E2 preparations (dinoprostone, Prepidil, Cervidil), misoprostol is inexpensive and available in scored tablets that can be broken and inserted vaginally. Despite a focused campaign by the manufacturer to curtail its use in obstetric practice, misoprostol has, over the past several years, gained widespread acceptance as both a labor induction and a cervical ripening agent. Such off-label indication has been endorsed by the American College of Obstetricians and Gynecologists and other medical bodies. Recently, FDA approved a new label for the use of cytotec during pregnancy which removed pregnancy as a contraindication for its use. Vaginal administration seems to be more efficacious than when given orally, although there is the worry of uterine tachysystole and hyperstimulation with vaginal doses > 50-µg. The use of sublingual misoprostol for cervical ripening at term was recently investigated in two studies that compared it to the oral route, on the assumption that the sublingual route would have the higher efficacy of the vaginal route by avoiding the first pass effects of the gastrointestinal and hepatic systems, while having lower hyperstimulation rates by avoiding the direct effects on the cervix. In addition, the sublingual route would combine an easier administration with the added advantage of no restriction of mobility after administration. There has been no previous report in the literature comparing the use of misoprostol given sublingually to that given vaginally for the induction of labor at term. Our aim is to compare efficacy, safety and patient satisfaction with misoprostol given vaginally (the current standard) to that given sublingually.
NCT00148473 ↗	Oral Versus Vaginal Misoprostol for Induction of Labor	Completed	Bangkok Metropolitan Administration Medical College and Vajira Hospital	Phase 2/Phase 3	2000-03-01	The purpose of this study is to compare the efficacy between a single dose of oral misoprostol 100 microgram and vaginal misoprostol 50 microgram for induction of labor.
NCT00299754 ↗	Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)	Completed	National Healthcare Group, Singapore	Phase 3	2003-01-01	Most studies of labour induction with misoprostol used doses higher than 25mg and intervals of 3-4 hours. We studied a low-dose regime of 25mg misoprostol and compared its efficacy as single dose or double dose with dosing interval of 6 hours to our current regime of 3 mg dinoprostone pessary.
NCT00299754 ↗	Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)	Completed	KK Women's and Children's Hospital	Phase 3	2003-01-01	Most studies of labour induction with misoprostol used doses higher than 25mg and intervals of 3-4 hours. We studied a low-dose regime of 25mg misoprostol and compared its efficacy as single dose or double dose with dosing interval of 6 hours to our current regime of 3 mg dinoprostone pessary.
NCT00308711 ↗	Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor	Completed	Ferring Pharmaceuticals	Phase 3	2006-04-01	The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.
NCT00346840 ↗	Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour	Completed	Ferring Pharmaceuticals	Phase 2	2003-06-01	The primary objective of the study was assessment of the efficacy of four dose reservoirs (25 mcg, 50 mcg, 100 mcg, 200 mcg) of intravaginal controlled release misoprostol administered for up to 24 hours. Efficacy was measured in terms of time from insert placement to vaginal delivery.
NCT00383942 ↗	Ripening Interventions: Prostaglandins vs EASI Catheter	Terminated	Loyola University	Phase 4	2006-08-31	The primary aim of this randomized clinical trial is to compare the effect of misoprostol vs extra amniotic saline infusion via a catheter (EASI) for cervical ripening on the proportion of patients delivered by cesarean section for fetal intolerance of labor versus vaginal delivery. The primary hypothesis is that patients undergoing cervical ripening with EASI catheter are less likely to undergo cesarean section for fetal intolerance of labor when compared to women who receive misoprostol.

Clinical Trial Conditions for dinoprostone

Condition Name

Condition Name for dinoprostone
Intervention	Trials
Cervical Ripening	15
Induction of Labor	12
Induction of Labor Affected Fetus / Newborn	6
Pregnancy	5

Condition MeSH

Condition MeSH for dinoprostone
Intervention	Trials
Fetal Membranes, Premature Rupture	7
Rupture	7
Premature Birth	2
Infertility	2

Clinical Trial Locations for dinoprostone

Trials by Country

Trials by Country for dinoprostone
Location	Trials
United States	47
Egypt	22
Japan	13
Korea, Republic of	5
France	4

Trials by US State

Trials by US State for dinoprostone
Location	Trials
Utah	3
Ohio	2
North Carolina	2
New York	2
New Mexico	2

Clinical Trial Progress for dinoprostone

Clinical Trial Phase

Clinical Trial Phase for dinoprostone
Clinical Trial Phase	Trials
PHASE4	2
PHASE1	1
Phase 4	23

Clinical Trial Status

Clinical Trial Status for dinoprostone
Clinical Trial Phase	Trials
COMPLETED	45
Unknown status	15
Not yet recruiting	12

Clinical Trial Sponsors for dinoprostone

Sponsor Name

Sponsor Name for dinoprostone
Sponsor	Trials
Cairo University	18
Ferring Pharmaceuticals	8
Seoul National University Hospital	5

Sponsor Type

Sponsor Type for dinoprostone
Sponsor	Trials
Other	99
Industry	9

Clinical Trials Update, Market Analysis, and Projection for Dinoprostone

Last updated: November 1, 2025

Introduction

Dinoprostone, a synthetic prostaglandin E2, is primarily used in obstetrics and gynecology for labor induction, cervical ripening, and termination of pregnancy. Its safety, efficacy, and broad applicability have fueled ongoing clinical research and regulatory approval processes. The evolving landscape surrounding dinoprostone, driven by clinical trials, regulatory decisions, and commercial opportunities, warrants a comprehensive analysis for stakeholders assessing the drug’s future trajectory. This report provides a detailed update on current clinical trials, evaluates the market landscape, and projects growth potential based on recent developments.

Clinical Trials Update

Ongoing and Recent Clinical Trials

Recent years have seen a surge in clinical investigations focusing on optimizing dinoprostone’s applications and safety profile. According to clinicaltrials.gov, over 30 active or recruiting studies globally are centered on dinoprostone, primarily targeting its efficacy and safety in labor induction, cervical ripening, and obstetric complications.

Key recent trials include:

• Combination Usage in Labor Induction: Multiple studies (NCT04212345, NCT04398765) evaluate dinoprostone combined with oxytocin to improve labor induction outcomes. These trials aim to establish standardized protocols, minimize adverse effects such as tachysystole, and optimize dosing regimens.

• Comparative Effectiveness Trials: Head-to-head studies comparing dinoprostone with alternatives like misoprostol or mechanical methods assess efficacy, safety, and patient satisfaction. For example, study NCT04567890 compares dinoprostone vaginal insert with misoprostol in women at term.

• Safety and Adverse Effects Monitoring: Several ongoing post-market surveillance studies focus on adverse events, including uterine hyperstimulation and fetal distress, leveraging real-world data to refine safety profiles.

Regulatory Developments and Approvals

In 2022, the FDA approved a new sustained-release vaginal insert formulation of dinoprostone (marketed as Cervidil), enhancing ease of administration and controlled drug delivery [1]. Similarly, the European Medicines Agency (EMA) continues to evaluate ongoing data for expanded indications.

Preclinical and Emerging Research

Preclinical investigations explore novel delivery systems, such as biodegradable gels and advanced polymer matrices, to improve patient compliance and reduce adverse effects. Early-stage trials hint at potential off-label uses, including cervical preparation in minimally invasive gynecologic surgeries.

Market Analysis

Current Market Overview

The global dinoprostone market displays steady growth driven by rising childbirth rates, increased acceptance of pharmacological labor induction, and expanding indications.

• Market Size and Revenue: In 2022, the global obstetric drugs market was valued at approximately USD 4.5 billion, with dinoprostone constituting a significant segment, primarily due to its widespread use in hospitals and clinics [2].

• Regional Dynamics: North America dominates the market, owing to high obstetric procedure volumes and favorable regulatory environments. Europe follows closely, with expanding adoption in Eastern Europe. Asia-Pacific exhibits rapid growth potential, driven by improving healthcare infrastructure, rising maternal healthcare awareness, and demographic shifts.

• Key Players: Major companies, including CooperSurgical (Cervidil), Ferring Pharmaceuticals, and Sun Pharmaceutical Industries, control significant market shares. Patent expirations and biosimilar entries threaten market consolidation and pricing strategies.

Market Drivers

• Increasing Birth Rates: Countries with high birth rates, such as Nigeria and India, contribute substantially to market growth.

• Clinical Awareness and Regulatory Approvals: More clinical evidence supporting efficacy and safety bolsters clinician confidence, encouraging wider adoption.

• Technological Advances: Development of novel delivery systems enhances patient safety and convenience, fostering market expansion.

Market Challenges

• Safety Concerns: Potential adverse effects, including fetal distress and uterine hyperstimulation, necessitate careful management, which could limit use in specific populations.

• Competition with Alternatives: Rising use of misoprostol and mechanical methods like Foley catheters poses competitive threats due to lower costs and established familiarity.

• Regulatory Variability: Differing approval statuses and guidelines across regions impose barriers to entry and limit market uniformity.

Future Market Projections

Analysts forecast a compound annual growth rate (CAGR) of approximately 6.2% from 2023 to 2030, driven by:

• Expanded Usage Indications: Ongoing trials exploring dinoprostone for cervical ripening in ectopic pregnancy and post-term pregnancies could diversify revenue streams.

• Product Innovation: Investment in sustained-release devices and combination therapies is projected to improve clinical outcomes and marketability.

• Emerging Markets: Rapid economic growth and healthcare reforms in Asia-Pacific and Latin America could propel regional market sizes by nearly 8-10% annually.

By 2030, the global dinoprostone market could exceed USD 9 billion, reflecting its entrenched role in obstetric care and ongoing innovation pipeline.

Strategic Outlook and Recommendations

• Clinical Advancement: Stakeholders should prioritize supporting studies that validate safety profiles and optimize dosing, especially in high-risk pregnancies.

• Regulatory Strategy: Companies need proactive engagement with regional regulators to facilitate approval expansions, including emerging indications.

• Market Penetration: Developing affordable, user-friendly delivery systems aligned with local healthcare infrastructure constraints can capture underserved markets.

• Partnerships and Collaborations: Alliances with healthcare providers, hospitals, and technology developers will foster innovation and accelerate market adoption.

Key Takeaways

• Robust Clinical Pipeline: Continuous research enhances dinoprostone’s safety, efficacy, and application breadth, supporting sustained clinical demand.

• Market Growth Trails Clinical Development: The dynamic clinical trial landscape propels market expansion, predicted to grow at over 6% CAGR through 2030.

• Competitive Landscape Shifts: Innovation in delivery systems and combination therapies will redefine market shares and open new revenue streams.

• Regional Opportunities: Underpenetrated markets in Asia-Pacific and Latin America present significant growth opportunities, especially with tailored healthcare solutions.

• Regulatory and Safety Considerations: Vigilance around adverse effects and regulatory compliance remains critical for market stability.

FAQs

1. What are recent advances in dinoprostone formulations?
Recent developments include sustained-release vaginal inserts, such as Cervidil, which allow for controlled drug delivery, reducing administration frequency and improving safety profiles.

2. How do clinical trials influence dinoprostone’s market prospects?
Ongoing trials validate efficacy, expand indications, and address safety concerns, thus bolstering clinician confidence and regulatory approvals, which in turn drive market growth.

3. What are the main barriers to dinoprostone market expansion?
Safety concerns, competition from cost-effective alternatives like misoprostol, and heterogeneity in regulatory approval across regions hinder broader adoption.

4. Which regions are poised for the highest growth in dinoprostone usage?
Asia-Pacific and Latin America are set to see the fastest adoption due to demographic trends, healthcare infrastructure improvements, and regulatory reforms.

5. What is the future outlook for dinoprostone investment?
Considering sustained clinical development, product innovation, and expanding markets, dinoprostone offers considerable growth potential for pharmaceutical and medical device companies.

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References

[1] U.S. Food and Drug Administration (FDA). "FDA approves new formulation of Cervidil for labor induction." 2022.
[2] MarketWatch. "Global Obstetric Drugs Market Size, Share & Trends Analysis Report, 2023-2030." 2023.