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Last Updated: February 14, 2025

CLINICAL TRIALS PROFILE FOR PROSTIN E2


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All Clinical Trials for Prostin E2

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00141895 ↗ A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Termination for Intrauterine Fetal Death Terminated American University of Beirut Medical Center Phase 3 2004-09-01 Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the United States since 1988 as a gastric cytoprotective agent. Despite a focused campaign by the manufacturer to curtail its use in obstetric practice, misoprostol has, over the past several years, gained widespread acceptance to effect the medical termination of pregnancy in the second trimester, either alone or after pretreatment with mifepristone. The primary reasons for this prompt incorporation into standard practice include its low cost and the lack of stringent storage requirements. Vaginal administration seems to be more efficacious than when given orally. The use of sublingual misoprostol for first trimester abortions has been extensively investigated as evidenced by the large number of publications comparing sublingual to other routes of misoprostol for first trimester pregnancy termination, on the assumption that the sublingual route would have a similar efficacy of the vaginal route. 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 second trimester termination following intrauterine fetal death. Our aim is to compare efficacy, safety and patient satisfaction with misoprostol given vaginally (the current standard) to that given sublingually.
NCT00545194 ↗ Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess Completed Institut National de la Santé Et de la Recherche Médicale, France Phase 3 2002-01-01 The aim of this study is to compare two different preparation
NCT01635439 ↗ Prostin and Propess in Induction of Labor Completed North West Armed Forces Hospital Phase 3 2010-12-01 The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2 (Dinoprostone vaginal Tablet).
NCT01635439 ↗ Prostin and Propess in Induction of Labor Completed Ain Shams University Phase 3 2010-12-01 The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2 (Dinoprostone vaginal Tablet).
NCT02620215 ↗ Cervical Ripening Balloon in Induction of Labour at Term Completed University of Malaya Phase 4 2015-11-01 About 1 in 6 deliveries in KKH are induced with prostaglandins. Inpatient induction can be a lengthy process especially when cervical priming is required. Although mechanical method of induction of labour (IOL) is established, its use in Singapore is uncommon. Systematic reviews comparing mechanical method against pharmacological and surgical IOL showed that mechanical method has similar efficacy with lower risk profile. As IOL is a common obstetric procedure, a revisit on the techniques is warranted. A multi-centre randomised controlled trial concluded that both cervical ripening balloon and prostaglandin are effective and complementary methods for IOL in uncomplicated singleton pregnancies, but did not examined the effects of pain. The investigators propose to evaluate the adverse events in the 12 hours after CRB or 1st prostaglandin insertion, its efficiency in term singleton IOL in Singapore context and test the acceptability of women in Singapore in using the CRB as an alternative method of induction of labour while using a non-incremental balloon filling regime. Currently, there is no efficient method of induction that can be used safely in an outpatient setting. Through this study, the investigators hope to show that there are no major adverse events in the 12h after patients are induced with CRB, this potentially supports outpatient IOL with CRB which can reduce hospitalisation and medical costs. A non-incremental balloon filling regime will decrease time delays and may increase patient satisfaction during its use in induction of labour.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Prostin E2

Condition Name

Condition Name for Prostin E2
Intervention Trials
IUCD Complication 2
Postmenopausal Bleeding 1
Efficacy 1
Pregnancy 1
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Condition MeSH

Condition MeSH for Prostin E2
Intervention Trials
Rupture 1
Fetal Membranes, Premature Rupture 1
Hemorrhage 1
Obstetric Labor Complications 1
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Clinical Trial Locations for Prostin E2

Trials by Country

Trials by Country for Prostin E2
Location Trials
Egypt 3
Singapore 2
Croatia 1
Saudi Arabia 1
United Kingdom 1
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Clinical Trial Progress for Prostin E2

Clinical Trial Phase

Clinical Trial Phase for Prostin E2
Clinical Trial Phase Trials
Phase 4 3
Phase 3 3
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Prostin E2
Clinical Trial Phase Trials
Completed 4
Not yet recruiting 3
Recruiting 2
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Clinical Trial Sponsors for Prostin E2

Sponsor Name

Sponsor Name for Prostin E2
Sponsor Trials
Aswan University Hospital 3
South Warwickshire NHS Foundation Trust 1
Institut National de la Santé Et de la Recherche Médicale, France 1
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Sponsor Type

Sponsor Type for Prostin E2
Sponsor Trials
Other 22
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Prostin E2: Clinical Trials, Market Analysis, and Projections

Introduction to Prostin E2

Prostin E2, a formulation of prostaglandin E2 (PGE2), is a crucial medication in obstetrics, particularly for cervical ripening and labor induction. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Cervical Ripening and Labor Induction

Prostin E2 has been extensively studied in clinical trials for its efficacy in cervical ripening and labor induction. A cumulative analysis of 59 clinical trials involving 3313 pregnancies demonstrated that PGE2 gel is highly effective in enhancing cervical effacement and dilation, reducing initial induction failures, shortening the induction-delivery interval, and lowering the rate of cesarean sections due to failure to progress[1].

In patients with an unfavorable cervix, the success rate of labor induction was significantly higher with PGE2 gel, achieving success in 83% of cases compared to 53% in untreated patients. The gel can be administered intracervically, intravaginally, or extraamniotically, with intracervical administration being more effective in women with an unfavorable cervix[1].

Safety Profile

The safety profile of Prostin E2 is favorable, with uterine hyperstimulation or pathologic fetal heart rate patterns occurring in less than 1% of cases. These effects are usually dose-related, self-contained, and reversible with beta-adrenergic tocolytic therapy. Maternal systemic effects are negligible at the doses used for labor induction[1].

Comparative Studies

A retrospective study comparing Prostin E2 tablets with Propess (another PGE2 formulation) in nulliparous women showed that both formulations were effective, but Propess had a shorter induction-to-birth interval and higher rates of cervical ripening within 12 and 24 hours. However, both formulations had similar rates of oxytocin augmentation and cesarean sections[3].

Market Analysis

Global Market Overview

The global Prostaglandin E2 market is segmented by type, application, and region. The market has seen significant growth due to its diverse applications, including cancer treatment, neurological treatment, and endocrinological treatment. The market size in 2023 was substantial, with a projected compound annual growth rate (CAGR) expected to drive further expansion from 2024 to 2031[2].

Regional Analysis

The market is segmented into five major regions: North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. Each region has its own set of driving factors and growth trends. For instance, the Asia-Pacific region is expected to show significant growth due to increasing healthcare expenditure and a growing awareness of advanced medical treatments[2].

Key Players and Competitors

The Prostaglandin E2 market includes several key players such as RD Systems, Abcam, Stemgent, Cayman Chemical, and Santa Cruz Biotechnology. These companies are involved in the production and distribution of various forms of PGE2, contributing to the market's competitive landscape[2].

Market Projections

Growth Forecast

The global Prostaglandin E2 market is forecasted to experience robust growth from 2024 to 2031. The CAGR for this period is expected to be significant, driven by increasing demand for PGE2 in various medical applications. The market size is projected to expand substantially, with the Asia-Pacific region expected to be a major contributor to this growth[2].

Driving Factors

Several factors are driving the growth of the Prostaglandin E2 market. These include the increasing prevalence of chronic inflammatory diseases, growing recognition of the role of PGE2 in cancer treatment, and advancements in medical technology. Additionally, the COVID-19 pandemic has accelerated the need for effective medical treatments, further boosting the market[5].

Projections for Prostin E2

Future Applications

Prostin E2 is expected to see expanded use beyond labor induction. Its efficacy in other medical conditions, such as cancer and neurological disorders, is being explored. The EP4 subtype of the PGE2 receptor, in particular, is gaining attention for its potential in treating chronic inflammatory diseases and cancer, with the market for this subtype projected to reach USD 0.77 billion by 2032[5].

Regulatory Considerations

Despite its proven efficacy, Prostin E2 is not commercially available in all regions, including the US, where it must be prepared from suppositories. Efforts to gain regulatory approval for prefabricated PGE2 delivery systems are ongoing, which could further expand its market reach and convenience of use[1].

Key Takeaways

  • Clinical Efficacy: Prostin E2 is highly effective in cervical ripening and labor induction, with a favorable safety profile.
  • Market Growth: The global Prostaglandin E2 market is expected to grow significantly from 2024 to 2031, driven by increasing demand and diverse applications.
  • Regional Trends: The Asia-Pacific region is anticipated to be a major contributor to the market's growth.
  • Future Applications: Prostin E2 is expected to see expanded use in other medical conditions, including cancer and neurological disorders.
  • Regulatory Approval: Efforts are ongoing to gain regulatory approval for prefabricated PGE2 delivery systems.

FAQs

What is the primary use of Prostin E2 in clinical settings?

Prostin E2 is primarily used for cervical ripening and labor induction.

How effective is Prostin E2 in labor induction?

Prostin E2 is highly effective, achieving success in 83% of cases in patients with an unfavorable cervix and reducing the need for cesarean sections due to failure to progress[1].

What are the common side effects of Prostin E2?

Side effects are mild and minor, with uterine hyperstimulation or pathologic fetal heart rate patterns occurring in less than 1% of cases[1].

What is the projected growth rate of the Prostaglandin E2 market?

The market is expected to exhibit a significant CAGR from 2024 to 2031, driven by increasing demand and diverse applications[2].

Which regions are expected to drive the growth of the Prostaglandin E2 market?

The Asia-Pacific region, along with North America and Europe, is expected to be a major contributor to the market's growth[2].

Sources

  1. Prostaglandin E2 gel for cervical ripening and induction of labor. PubMed.
  2. Prostaglandin E2 Market Report 2024 (Global Edition). Cognitive Market Research.
  3. Comparison of the Dinoprostone Vaginal Insert and Prostin E2 Tablet for the Induction of Labor in Nulliparous Women. MDPI.
  4. PROSTIN E2®. Pfizer Labeling.
  5. Prostaglandin E2 Receptor EP4 Subtype Market Forecast To 2031. Business Research Insights.

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