CLINICAL TRIALS PROFILE FOR DINOPROSTONE

All Clinical Trials for dinoprostone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
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.

Clinical Trial Conditions for dinoprostone

Condition Name

Condition Name for dinoprostone
Intervention	Trials
Cervical Ripening	15
Induction of Labor	10
Induction of Labor Affected Fetus / Newborn	6
Labor, Induced	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

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Trials by Country for dinoprostone
Location	Trials
United States	47
Egypt	19
Japan	13
Korea, Republic of	5
United Kingdom	4

Trials by US State

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−

Trials by US State for dinoprostone
Location	Trials
Utah	3
Wisconsin	2
Texas	2
Tennessee	2
South Carolina	2

Clinical Trial Progress for dinoprostone

Clinical Trial Phase

Clinical Trial Phase for dinoprostone
Clinical Trial Phase	Trials
Phase 4	23
Phase 3	22
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for dinoprostone
Clinical Trial Phase	Trials
Completed	42
Unknown status	15
Not yet recruiting	12

Clinical Trial Sponsors for dinoprostone

Sponsor Name

Sponsor Name for dinoprostone
Sponsor	Trials
Cairo University	17
Ferring Pharmaceuticals	8
Seoul National University Hospital	5

Sponsor Type

Sponsor Type for dinoprostone
Sponsor	Trials
Other	94
Industry	9

Dinoprostone: Clinical Trials, Market Analysis, and Projections

Introduction to Dinoprostone

Dinoprostone, a synthetic form of prostaglandin E2, is widely used in obstetrics for cervical ripening and labor induction. It is available in various forms, including vaginal inserts, gels, and suppositories. Here, we will delve into the latest clinical trials, market analysis, and projections for dinoprostone.

Clinical Trials Update

RE-DINO Multicenter Randomized Trial

A recent study, the RE-DINO multicenter randomized trial, investigated the efficacy of a second dinoprostone pessary compared to oxytocin in patients who did not respond to the initial prostaglandin E2 maturation for labor induction. The trial, conducted in seven French hospitals, included pregnant women at more than 37 weeks of gestation with unfavorable cervical conditions. The results showed no superiority of a second dinoprostone pessary over oxytocin in achieving vaginal delivery. Additionally, the study highlighted a higher incidence of postpartum hemorrhage and newborn acidosis in the dinoprostone group, although these differences were not statistically significant[1].

Combined Use of Dinoprostone and Foley Catheter

Another clinical trial, led by Rodney K. Edwards at the University of Oklahoma, explored the combined use of a controlled release dinoprostone vaginal insert and a Foley catheter for cervical ripening and labor induction. This pilot study aimed to compare the efficacy and safety of this combination versus the use of a Foley catheter alone. The trial hypothesized that the combined use would decrease the median time from induction to vaginal delivery by at least four hours. While the study is ongoing, it will provide valuable insights into the safety and efficacy of this combined approach[4].

Market Analysis

Market Size and Growth

The dinoprostone market is projected to experience significant growth from 2023 to 2030. According to market reports, the global dinoprostone market is expected to grow from USD 0.14 billion in 2023 to USD 0.24 billion by 2030, at a Compound Annual Growth Rate (CAGR) of 10.2% during the forecast period. This growth is driven by increasing demand for dinoprostone due to its applications in labor induction, postpartum hemorrhage, and abortion[2].

Key Players

The dinoprostone market is dominated by several major players, including Ferring, Actavis (TEVA), Pharmacia & Upjohn (Pfizer), Controlled Therapeutics (Scotland) Limited, and Theramex. These companies are investing in research and development to enhance the performance and application range of dinoprostone products[2][5].

Market Segmentation

The dinoprostone market is segmented based on type, application, and geography. The types include injections, vaginal suppositories, gels, and tablets. Applications span labor induction, postpartum hemorrhage, and abortion. The market is also analyzed geographically, with insights into country-level market dynamics and opportunities[2][5].

Market Projections

Drivers of Growth

Several factors are driving the growth of the dinoprostone market:

• Increasing Labor Induction Rates: The rate of labor induction has been rising globally. For instance, in the U.S., labor induction rates increased by 40% between 1997 and 2017, which is expected to boost the demand for dinoprostone[3].
• Rising Abortion Rates: According to the World Health Organization (WHO), there are approximately 73 million abortions worldwide each year, contributing to the increased demand for dinoprostone[3].
• Advances in Biotechnology and Pharmaceuticals: Technological innovations and advancements in the pharmaceutical sector are optimizing the performance of dinoprostone, enabling it to be used in a wider range of applications[5].

Opportunities and Challenges

• Opportunities: The rising incidence of postpartum hemorrhage and the need for effective uterotonic agents present significant opportunities for the dinoprostone market. Additionally, collaborations and advancements in biotechnology are expected to drive market growth[3].
• Challenges: Despite the growth potential, the market faces challenges such as the need for stringent regulatory approvals and the potential side effects associated with dinoprostone use, such as postpartum hemorrhage and newborn acidosis[1][3].

Global Uterotonic Agent Market Context

The global uterotonic agent market, which includes dinoprostone, is expected to witness significant growth driven by rising cases of abortion and childbirth using labor induction. The market is segmented by drug type, indication, route of administration, and distribution channel. Dinoprostone is one of the key drugs in this market, alongside oxytocin, carboprost, and methylergonovine[3].

Key Takeaways

• Clinical Trials: Recent trials indicate that repeated use of dinoprostone may not be superior to oxytocin for labor induction in non-responsive patients, but combined use with other methods like Foley catheters is being explored.
• Market Growth: The dinoprostone market is projected to grow at a CAGR of 10.2% from 2023 to 2030, driven by increasing demand for labor induction and other applications.
• Key Players: Major players like Ferring, Actavis, and Pfizer are dominant in the market, focusing on research and development to enhance product performance.
• Market Segmentation: The market is segmented by type, application, and geography, with a focus on labor induction, postpartum hemorrhage, and abortion.

FAQs

What is dinoprostone used for?

Dinoprostone is used for cervical ripening and labor induction, as well as in the management of postpartum hemorrhage and abortion.

What are the key drivers of the dinoprostone market?

The key drivers include increasing labor induction rates, rising abortion rates, and advances in biotechnology and pharmaceuticals.

Which companies are major players in the dinoprostone market?

Major players include Ferring, Actavis (TEVA), Pharmacia & Upjohn (Pfizer), Controlled Therapeutics (Scotland) Limited, and Theramex.

What are the potential side effects of dinoprostone?

Potential side effects include postpartum hemorrhage, newborn acidosis, and other maternal and fetal morbidities.

How is the dinoprostone market segmented?

The market is segmented by type (injections, vaginal suppositories, gels, tablets), application (labor induction, postpartum hemorrhage, abortion), and geography.

Sources

1. RE-DINO multicenter randomized trial: "Results of the RE-DINO multicenter randomized trial on the repeated use of dinoprostone pessary for labor induction" - PubMed.
2. Dinoprostone Market Report: "Dinoprostone Market Growth, Trends, and Insights 2024-2030" - Verified Market Reports.
3. Global Uterotonic Agent Market: "Uterotonic Agent Market Size, Industry Scope, & Forecast Analysis" - Data Bridge Market Research.
4. Combined Use of Dinoprostone and Foley Catheter: "Combined Use of the Controlled Release Dinoprostone Insert and Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening and Labor Induction in Term Women" - ClinicalTrials.gov.
5. Global Dinoprostone Market Research Report: "Global Dinoprostone Market Research Report 2022" - MarketResearch.com.