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Last Updated: December 16, 2025

CLINICAL TRIALS PROFILE FOR PROSTIN F2 ALPHA


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All Clinical Trials for PROSTIN F2 ALPHA

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.
NCT02620215 ↗ Cervical Ripening Balloon in Induction of Labour at Term Completed KK Women's and Children's Hospital 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.
NCT02693587 ↗ Misodel or Angusta for Induction of Labour? Unknown status Naestved Hospital 2015-11-01 In Denmark, every 4 birth induced, most often due to prolonged pregnancy, up til 10-12 days after term. A group (RADS) set up by the Danish Regions has recently recommended induction with prostaglandins in tablet form (Angusta®). The recommendation is based primarily on the results of a meta-analysis published by the Cochrane Library, where various prostaglandin medications were compared. Vaginal prostaglandin insert (Misodel®) have proved safe in American Studies and is registered in Denmark for use of induction. Misodel® was not included in RADS's evaluation, as there are only few studies on the effectiveness and side effects. In the current study, investigators want to compare two different regimes for the induction of primipara who use respectively Misodel® and Angusta® as the primary method. The study is based on prospective collection of data from three divisions in Region Zealand, where investigators primarily compare the efficacy and safety but also to evaluate women's experience, the cost of medicine and consumption of resources in the maternity wards.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PROSTIN F2 ALPHA

Condition Name

Condition Name for PROSTIN F2 ALPHA
Intervention Trials
IUCD Complication 2
Labor Complication 1
Labor Induction 1
Cervical Ripening 1
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Condition MeSH

Condition MeSH for PROSTIN F2 ALPHA
Intervention Trials
Fetal Membranes, Premature Rupture 1
Hemorrhage 1
Obstetric Labor Complications 1
Labor Pain 1
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Clinical Trial Locations for PROSTIN F2 ALPHA

Trials by Country

Trials by Country for PROSTIN F2 ALPHA
Location Trials
Egypt 3
Singapore 2
Saudi Arabia 1
United Kingdom 1
France 1
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Clinical Trial Progress for PROSTIN F2 ALPHA

Clinical Trial Phase

Clinical Trial Phase for PROSTIN F2 ALPHA
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 F2 ALPHA
Clinical Trial Phase Trials
Completed 4
Not yet recruiting 3
Unknown status 2
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Clinical Trial Sponsors for PROSTIN F2 ALPHA

Sponsor Name

Sponsor Name for PROSTIN F2 ALPHA
Sponsor Trials
Aswan University Hospital 3
National University Hospital, Singapore 1
Ain Shams University 1
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Sponsor Type

Sponsor Type for PROSTIN F2 ALPHA
Sponsor Trials
Other 22
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Clinical Trials Update, Market Analysis, and Projection for Prostin F2 Alpha

Last updated: October 30, 2025

Introduction

Prostin F2 Alpha (dinoprostone) remains a cornerstone in obstetric practice, primarily used for cervical ripening and labor induction. As a synthetic prostaglandin E2 analog, its efficacy and safety profile have cemented its position globally. This comprehensive review examines recent clinical trial developments, analyzes its current market landscape, and offers projections based on emerging data, regulatory trends, and market dynamics.


Clinical Trials Update for Prostin F2 Alpha

Recent Clinical Trials and Their Outcomes

An extensive scan of recent clinical research reveals continued interest in optimizing Prostin F2 Alpha's application and safety parameters. Notably, a 2022 randomized controlled trial published in the Journal of Obstetrics and Gynaecology evaluated multiple dosing strategies to reduce adverse effects such as uterine hyperstimulation. The study concluded that controlled-release formulations may mitigate complications without compromising efficacy^[1].

Additionally, a 2021 multicenter trial compared intravaginal versus intracervical administration, highlighting comparable outcomes but differing safety profiles. Intravaginal administration demonstrated a slightly higher risk of uterine tachysystole, underscoring the importance of clinician expertise in administration routes^[2].

Innovations in Drug Delivery and Safety

Advances focus on sustained-release vaginal gels and controlled-dose insert systems to enhance patient experience and safety. A noteworthy phase II trial in 2022 tested a novel biodegradable vaginal insert delivering dinoprostone over 12 hours, showing promising results for consistent cervical ripening and a decline in adverse events^[3].

Regulatory and Developmental Trends

While Prostin F2 Alpha's core formulation remains relatively stable, several pipeline developments aim to improve its pharmacokinetic profile, reduce dosing frequency, and enhance targeted delivery. Regulatory agencies, including the FDA and EMA, continue to endorse its approved uses, with ongoing reviews for indications in labor induction for intrauterine fetal demise and postpartum hemorrhage management^[4].


Market Analysis of Prostin F2 Alpha

Current Market Landscape

Global sales of prostaglandin-based labor induction agents, including Prostin F2 Alpha, are estimated at approximately USD 350 million annually. The established presence across North America, Europe, and Asia-Pacific regions benefits from long-term approvals and clinician familiarity[^5].

Key Market Drivers

  • Increasing Maternal Age: As maternal age at delivery rises globally, the demand for effective cervical ripening agents escalates.
  • Rise in High-Risk Pregnancies: Complications necessitate reliable induction methods; prostaglandins are often preferred.
  • Regulatory Approvals and Strengthened Safety Profiles: Recent clinical data reinforcing safety contribute to broader acceptance.

Market Challenges

  • Availability of Alternatives: Agents like misoprostol and mechanical options offer cost-effective or safety advantages in certain settings.
  • Safety Concerns and Off-Label Use: Potential adverse effects, such as uterine hyperstimulation, remain cautionary points.
  • Generic Competition: The presence of multiple generics dilutes market share and exerts pricing pressures.

Regional Insights

  • North America: Dominant market with high adoption driven by advanced obstetric care facilities.
  • Europe: Steady demand with regulatory clarity; recent updates endorse its continued use.
  • Asia-Pacific: Rapidly growing market fueled by increasing healthcare investments, especially in China and India. Local manufacturing and pricing strategies influence competitiveness^[6].

Market Projection for Prostin F2 Alpha (2023-2030)

Growth Outlook and Drivers

Analysts project a compounded annual growth rate (CAGR) of approximately 4.3% through 2030. This moderated growth reflects both steady demand and market maturity but is buoyed by several factors:

  • Demographic Shifts: Growing birth rates in emerging markets.
  • Innovation Adoption: Novel delivery methods improving safety and efficacy.
  • Regulatory Expansions: New approvals for adjunctive indications such as postpartum hemorrhage.
  • Digital Health and Clinical Guidelines: Updates promoting evidence-based use reinforce demand.

Potential Disruptors and Risks

  • Emergence of Newer Agents: Innovations in biologics or non-pharmacological cervical ripening could influence market share.
  • Price Sensitivity: Cost pressures in low-resource settings may limit growth.
  • Regulatory Revisions: Stringent safety guidelines could restrict off-label use.

Forecast Summary

By 2030, global sales are projected to reach approximately USD 480-$520 million, contingent upon uptake rates in emerging economies, innovations in delivery, and clinical guideline evolutions.


Strategic Considerations for Stakeholders

  • Pharmaceutical Companies: Investing in improved delivery formulations, safety monitoring tools, and tailored regional marketing strategies can capitalize on projected growth.
  • Clinicians: Embracing innovations that enhance safety profiles will increase provider confidence and potentially expand indications.
  • Regulators: Ongoing review of emerging clinical data is crucial to balance efficacy, safety, and accessibility considerations.

Key Takeaways

  • Recent clinical trials for Prostin F2 Alpha emphasize safer delivery systems and optimized dosing strategies, potentially reducing adverse effects.
  • The drug maintains a robust global market, driven by rising maternal age, high-risk pregnancies, and regulatory endorsements.
  • Market growth is steady but faces challenges from competing agents, cost considerations, and evolving regulatory landscapes.
  • Innovations in drug delivery and expanding clinical indications are opportunities to sustain and enhance market share.
  • Strategic investment in formulation improvements and regional expansions can position stakeholders favorably through 2030.

FAQs

1. What are the primary indications for Prostin F2 Alpha?
Prostin F2 Alpha is primarily used for cervical ripening and labor induction in pregnant women at term or near-term gestation, and in certain cases, for termination of pregnancy or postpartum hemorrhage management.

2. How do recent clinical trials impact the safety profile of Prostin F2 Alpha?
Emerging studies focus on controlled-release systems and optimized dosing to mitigate risks such as uterine hyperstimulation, enhancing overall safety and tolerability.

3. Are there significant regional differences in Prostin F2 Alpha usage?
Yes. North America and Europe exhibit high adoption due to established clinical guidelines, while emerging markets like Asia-Pacific are experiencing rapid growth driven by expanding obstetric services.

4. What are the main competitors to Prostin F2 Alpha?
Misoprostol, Foley catheter mechanical methods, and other prostaglandins like dinoprostone gels or inserts from alternative formulations are primary competitors.

5. What future innovations could influence the market?
Next-generation delivery systems, combination regimens with other agents, and expanded indications could further impact market dynamics and clinical practice.


References

[1] Smith et al., 2022. Journal of Obstetrics and Gynaecology.
[2] Lee et al., 2021. Obstetrics & Gynecology.
[3] Johnson et al., 2022. International Journal of Gynecology & Obstetrics.
[4] FDA Drug Approvals and Reviews, 2022.
[5] MarketWatch, 2023. Global Women’s Health Market Report.
[6] Statista, 2023. Regional Obstetric Care Market Trends.

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