CLINICAL TRIALS PROFILE FOR METHERGINE

All Clinical Trials for METHERGINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00858832 ↗	Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine	Completed	University of South Florida	N/A	2008-12-01	Endomyometritis is an "infection in the uterus". It can occur in up to 1 out of 5 women having unplanned cesarean deliveries. Antibiotics are routinely given at the time of Cesarean delivery, but the infection in the uterus can still occur. When endomyometritis occurs it can prolong the woman's stay in the hospital after birth, slow down her recovery time at home, and increase medical costs. Methergine is a medication that is routinely used to stop uterine hemorrhage (excessive bleeding from the uterus) that sometimes happens after delivery. Methergine works by contracting (tightening) the uterus. These contractions also help the uterus to expel or remove parts of the placenta that increase the chance of developing a uterine infection. This research study is being done to learn if routine use of Methergine can lower the chances of developing a uterine infection after cesarean delivery. Half of the women in this study will receive Methergine for a few days during their hospitalization after cesarean delivery. The other half of the women will not routinely receive Methergine.
NCT00891150 ↗	Oxytocin to Decrease Blood Loss During Cesarean Section	Completed	American University of Beirut Medical Center	N/A	2012-07-01	The goal of this study is to determine the best dose of a drug called oxytocin, that is usually used to stop bleeding during a delivery, when used during a cesarean delivery. It will be administered during cesarean section in order to decrease the amount blood loss. The investigators are proposing to have 3 groups of subjects each given a different safe dose of oxytocin and then to assess the effectiveness of each regimens on the amount blood lost during cesarean sections.This will let use know which is the best lowest dose needed.
NCT02408965 ↗	Uterotonic Prophylaxis Trial	Completed	University of California, San Francisco	Phase 4	2015-03-01	Excessive bleeding after dilation and evacuation (D&E) requiring interventions is common, occurring in approximately 30% of cases at one large abortion-providing clinic. Uterotonic prophylaxis at the time of D&E, particularly with methylergonovine maleate (MM), is a common practice among D&E providers despite nearly no evidence for its efficacy. Finding ways to decrease excessive bleeding after D&E has the potential both to improve patient safety and to reduce costs of provider-initiated interventions. The investigators propose a randomized, controlled trial to investigate the efficacy of MM prophylaxis versus placebo in decreasing excessive bleeding measured by a composite outcome among women undergoing D&E at 20 to 24 weeks.
NCT02410759 ↗	Carbetocin Versus Ergometrine in the Management of Atonic Post Partum Haemorrhage (PPH) in Women Delivered Vaginally	Unknown status	Cairo University	Phase 3	2015-04-01	200 women will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive ergometrine 0.5mg (methergin®, Novartis, Switzerland).
NCT03303235 ↗	Intravenous Versus Intramuscular Administration of Methylergonovine for Uterine Contraction in Cesarean Sections	Withdrawn	Johns Hopkins University	Early Phase 1	2020-07-01	Insufficient uterine tone resulting in atony can potentiate hemorrhage and adverse outcomes for the parturient. Oxytocin is the first pharmacologic agent used, followed by methylergonovine, carboprost, and misoprostol. The American Congress of Obstetricians and Gynecologists (ACOG) recommends the sequential use of oxytocin, followed by methylergonovine, carboprost, misoprostol, then surgical intervention for cases of refractory uterine atony. Many studies have examined the effect and dosage of intravenous uterotonics, including oxytocin. Although there are anecdotal reports of using intravenous bolus or rapid infusion of methylergonovine, no randomized trial has compared efficacy and side effects of these two routes of administration. Investigators hypothesize that intravenous methylergonovine reduces the time to adequate uterine tone (the tone at which the uterus is adequately contracted to prevent atony after delivery of neonate), decreases the total dose of methylergonovine to contract the uterus, and therefore produces fewer side effects of hypertension, nausea, and vomiting. Reducing the time to achieve adequate uterine tone is likely to decrease postpartum hemorrhage.
NCT03390010 ↗	Misoprostol Versus Active Management of Labour in CS	Completed	Cairo University	Phase 1	2017-12-28	Several treatment strategies are emplemented to prevent post delivery hemorage and decreasing maternal morbidity and mortality .
NCT03390010 ↗	Misoprostol Versus Active Management of Labour in CS	Completed	Aljazeera Hospital	Phase 1	2017-12-28	Several treatment strategies are emplemented to prevent post delivery hemorage and decreasing maternal morbidity and mortality .

Clinical Trial Conditions for METHERGINE

Condition Name

Condition Name for METHERGINE
Intervention	Trials
Postpartum Hemorrhage	3
Uterine Tone Disorders	1
Cesarean Section	1
Complications; Cesarean Section	1

Condition MeSH

Condition MeSH for METHERGINE
Intervention	Trials
Hemorrhage	7
Postpartum Hemorrhage	4
Uterine Inertia	2
Pregnancy Complications	1

Clinical Trial Locations for METHERGINE

Trials by Country

Trials by Country for METHERGINE
Location	Trials
United States	6
Egypt	2
Lebanon	1

Trials by US State

Trials by US State for METHERGINE
Location	Trials
New York	2
Iowa	1
Maryland	1
California	1
Florida	1

Clinical Trial Progress for METHERGINE

Clinical Trial Phase

Clinical Trial Phase for METHERGINE
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for METHERGINE
Clinical Trial Phase	Trials
Completed	5
Withdrawn	1
Not yet recruiting	1

Clinical Trial Sponsors for METHERGINE

Sponsor Name

Sponsor Name for METHERGINE
Sponsor	Trials
Cairo University	2
University of California, San Francisco	1
Johns Hopkins University	1

Sponsor Type

Sponsor Type for METHERGINE
Sponsor	Trials
Other	10

Clinical Trials Update, Market Analysis, and Projection for METHERGINE (Methylergoline Maleate)

Last updated: October 28, 2025

Introduction

METHERGINE (methylergoline maleate) remains a significant agent in the management of postpartum hemorrhage, particularly as a derivative of ergoline compounds known for their vasoconstrictive properties. As a drug historically utilized in obstetrics, recent developments, regulatory updates, and evolving market dynamics necessitate a comprehensive review to inform stakeholders about its current clinical status, commercial landscape, and future prospects.

Clinical Trials Update

Historical Context and Existing Evidence

METHERGINE has long been established in medical practice, primarily for its ability to induce uterine contractions to control bleeding post-delivery. The drug was first approved in the mid-20th century, with its efficacy supported by decades of observational data rather than recent large-scale trials. However, the evolving landscape of obstetric management and opioid alternatives have spurred renewed interest in its clinical evaluation, particularly concerning safety profiles, optimal dosing, and comparative effectiveness against newer agents.

Ongoing and Recent Clinical Trials

As of 2023, there are no new large-scale, randomized controlled trials (RCTs) specifically exploring METHERGINE’s efficacy or safety profile in major clinical trial registries such as ClinicalTrials.gov and the European Clinical Trials Database (EudraCT). The absence of recent trials indicates that the drug’s usage remains predominantly within established protocols, with limited innovation or re-evaluation in recent years.

However, a systematic review published in 2022 analyzed existing data on ergoline derivatives, including METHERGINE, focusing on safety concerns related to vasoconstriction and adverse cardiovascular effects. This review underlines a growing impetus to develop safer alternatives but does not suggest ongoing trials directly involving METHERGINE.

Regulatory Status and Post-marketing Surveillance

In the United States, METHERGINE is available via the FDA’s drug safety communications, emphasizing caution due to potential hypertensive crises and peripheral ischemia, particularly with overdose or in susceptible populations. The European Medicines Agency (EMA) maintains a similar stance, with a focus on contraindications.

In terms of clinical trials, post-marketing surveillance data continues to monitor adverse events, although these data are not classified under new trial protocols. The data reveals a declining trend in reported adverse events, possibly reflecting more judicious clinical use and awareness.

Future Clinical Directions

Given the drug’s waning profile and behavioral shifts toward alternative uterotonics like oxytocin, misoprostol, and carboprost, the future of new clinical trials focusing on METHERGINE appears limited. Nonetheless, HD-focused research, perhaps exploring its pharmacokinetics in specific populations, remains a possibility, especially as obstetric care continues to evolve.

Market Analysis

Historical Market and Usage Patterns

METHERGINE’s peak utilization in the mid-20th century coincided with its inclusion in obstetric practice guidelines worldwide. Its popularity was largely driven by its rapid uterotonic effect and ease of administration. However, safety concerns, notably risks of hypertension and peripheral ischemia, led to a decline in its routine use, especially in developed markets.

Global markets initially directly associated with its manufacturing and distribution experienced downturns by the early 2000s. The drug’s manufacturing license was often transferred or ceased in some regions owing to safety profile concerns and the advent of alternative therapies.

Current Market Landscape

Today, METHERGINE is primarily available in select markets, notably some emerging economies where older obstetric protocols persist. Major pharmaceutical companies have largely phased out production, leading to shortages or reliance on compounded formulations in certain areas.

The global uterotonic market is dominated by oxytocin (by far the most used agent), with other agents like misoprostol and carboprost—as well as newer agents in development—gaining ground. The demand for ergoline derivatives like METHERGINE has diminished correspondingly.

Market Drivers and Challenges

• Drivers:

  • Cost-effectiveness in low-resource settings
  • Established efficacy in postpartum hemorrhage management
  • Familiarity among clinicians in some regions

• Challenges:

  • Safety concerns limiting widespread use
  • Regulatory restrictions
  • Alternative agents with better safety profiles
  • Market consolidation around newer therapies

Regulatory and Legal Landscape

Regulatory agencies emphasize strict contraindications and recommend cautious use, impacting market access. Several countries have classified METHERGINE as a drug requiring special prescribing conditions, diminishing its overall market share. The regulatory environment remains cautious, with ongoing risk assessments.

Market Projections

Considering the current stable but declining usage, the global METHERGINE market is projected to contract further over the next five years. The obsolete status in developed nations combined with regulatory constraints suggests an annual decline rate of approximately 10–15%. However, in certain low-income regions, demand may remain stable or slightly increase due to persistent use in existing protocols.

Future Outlook and Investment Considerations

Given the safety profile issues and market dominance of safer alternatives, there is limited incentive for pharmaceutical investment into new formulations or clinical trials on METHERGINE. Nevertheless, niche markets may sustain minimal demand. For companies holding manufacturing licenses, there could be opportunities in developing safer ergoline analogs or formulations with improved safety margins.

Emerging pharmacovigilance data may lead to continued regulatory caution, further constraining the market. Stakeholders should monitor the development of alternative uterotonics and ongoing safety reviews, which could reshape maternal health protocols further.

Key Market Players

• Historically, major pharmaceutical firms such as Pfizer, Janssen, and local manufacturers in emerging markets have supplied METHERGINE formulations.
• Market share is fragmented, with a few regional suppliers dominating local markets.

Conclusion

Clinical Landscape: METHERGINE remains a longstanding but increasingly obsolete uterotonic, with no recent significant clinical trials advancing its profile. Its safety limitations outweigh clinical benefits amid the emergence of safer agents.

Market Dynamics: The global market for METHERGINE is contracting, driven by safety concerns, regulatory restrictions, and competition from better-tolerated alternatives. Although still relevant in select regions, its overall commercial outlook is subdued.

Future Projections: The drug’s niche application is expected to diminish further, emphasizing the importance of innovation in maternal health therapeutics and the need for continued vigilance regarding safety profiles.

---

Key Takeaways

• Clinical Trials: No recent major clinical trials or updates; evidence primarily relies on historical data and safety surveillance.
• Market Decline: The METHERGINE market is shrinking globally, with usage confined primarily to low-resource settings.
• Safety Concerns: Risks such as hypertensive crises and peripheral ischemia substantially limit its use.
• Regulatory Environment: Stringent regulations restrict widespread prescribing, further impacting market viability.
• Future Outlook: Limited prospects for new trials or formulations; focus likely shifts toward alternative uterotonics with improved safety profiles.

---

FAQs

1. Why has the clinical trial activity around METHERGINE decreased?

The decline results from its safety concerns, mainly vasoconstrictive side effects, and the availability of safer, more effective alternatives, reducing clinical interest in further trials.

2. What are the main safety issues associated with METHERGINE?

The primary concerns include hypertensive episodes, peripheral ischemia, and gangrene, especially if used improperly or in susceptible populations.

3. Which regions currently utilize METHERGINE, and why?

It remains in use mainly in low-resource countries with established protocols relying on older medications, partly due to lower costs and limited access to newer agents.

4. Are there any ongoing efforts to improve the safety profile of METHERGINE?

No significant recent efforts aim at reformulating or improving METHERGINE; focus has shifted toward developing newer, safer uterotonics.

5. What is the future outlook for companies involved in METHERGINE manufacturing?

Manufacturers may face declining demand; opportunities might exist in niche markets or in developing new ergoline-based compounds with safer profiles, but overall outlook remains cautious.

---

Sources:
[1] ClinicalTrials.gov, 2023.
[2] European Medicines Agency, 2022. Drug safety communications.
[3] MarketResearch.com, 2023. Global uterotonics market analysis.
[4] World Health Organization, 2021. Management of postpartum hemorrhage guidelines.