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.

Clinical Trial Conditions for Methergine

Condition Name

Condition Name for Methergine
Intervention	Trials
Postpartum Hemorrhage	3
Twin; Complicating Pregnancy	1
Uterine Atony	1
Uterine Atony With Hemorrhage	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
Recruiting	1
Unknown status	1

Clinical Trial Sponsors for Methergine

Sponsor Name

Sponsor Name for Methergine
Sponsor	Trials
Cairo University	2
Johns Hopkins University	1
Aljazeera Hospital	1

Sponsor Type

Sponsor Type for Methergine
Sponsor	Trials
Other	10

Methergine Market Analysis and Financial Projection

Last updated: April 28, 2026

Methergine (methylergometrine): Clinical Trial Update, Market Analysis, and Projection

What is Methergine and where is it used clinically?

Methergine is the brand name for methylergometrine, an ergot alkaloid used to treat and prevent postpartum uterine bleeding associated with uterine atony and related uterine involution complications. The drug is also used in specific settings for uterine bleeding control per local labeling and guideline practice.

In most markets, methylergometrine is sold as a mature, off-patent therapy with a supply chain that includes generics and branded generics. Current market dynamics are therefore driven less by patent-led exclusivity and more by hospital formularies, procurement cycles, and competition among generic manufacturers.

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What is the current clinical trial status for methylergometrine (Methergine)?

No global, consistently tracked, late-stage interventional development program appears to be active for methylergometrine under the brand “Methergine” specifically. The available clinical research footprint for methylergometrine is largely historical, comparative, or focused on dose form, route of administration, and safety in postpartum contexts, with limited evidence of new Phase 3 or registrational trials that would materially change standard-of-care.

Key sources that typically anchor current trial visibility (registries and regulatory review archives) show that methylergometrine is largely represented by:

• Established postpartum use in label-aligned studies conducted earlier in time.
• Smaller studies and older comparative trials for uterotonic performance, adverse event profiles, and administration strategies.
• No clear modern, brand-driven Phase 3 program that would suggest near-term regulatory expansion.

For operational purposes, the clinical outlook is best treated as label maintenance and generic lifecycle management, rather than an active pipeline that can reset pricing power.

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How are regulatory and label constraints shaping near-term development?

Methylergometrine’s clinical positioning is constrained by:

• A defined indication set focused on postpartum uterine bleeding control.
• Class-associated ergot risks that require contraindication handling (for example, vascular and hypertensive risk populations) and careful administration protocols.
• Mature clinical documentation that reduces the probability of large incremental endpoints unless a new route, formulation, or delivery system is pursued.

These factors mean near-term “clinical trial updates” for Methergine are more likely to show up as post-marketing safety or local formulation work, not as new efficacy readouts.

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Market analysis

What does the Methergine market look like today?

The market is characterized by:

• Generic competition: Methylergometrine is widely available as generics across major geographies, compressing prices versus branded origin products.
• Institutional demand: Use is concentrated in hospitals with obstetric services, creating procurement-driven purchasing rather than retail-driven demand.
• Dose-form dependence: Sales track strongly with injectable usage in labor and postpartum management pathways.

The practical commercial reality for investors and R&D strategists is that incremental market growth is limited by clinical need stability. Volume growth is driven by:

• Population-level birth rates (and their regional mix).
• Institutional penetration in postpartum hemorrhage management bundles.
• Stocking practices and formulary stability.

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What are the main competitive dynamics?

Competition is determined by:

1. Generic price and supply reliability: Hospital purchasing favors consistent availability and low acquisition cost for short-dated or frequently replenished injectables.
2. Packaging and concentration equivalence: Substitution depends on dose matching, vial size, and ease of use in emergency settings.
3. Safety reputation and protocol integration: Contraindication awareness and protocol fit can influence whether a facility substitutes between uterotonics.

Because methylergometrine is an older product class, competitive differentiation is more operational than scientific.

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Where does Methergine sit relative to alternative uterotonics?

In postpartum hemorrhage management, methylergometrine competes within a broader uterotonic landscape that typically includes:

• Oxytocin (first-line in many pathways)
• Misoprostol
• Carbetocin (in some settings)
• Other uterotonic agents depending on local guideline adoption

Methylergometrine’s niche is often described as a targeted option where the uterine atony/bleeding pathway calls for ergot-derived uterotonics, subject to patient-specific contraindications.

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Projection

What is the likely market trajectory for methylergometrine through the mid-term?

Given the product maturity and generic competition, the market outlook is generally expected to follow a pattern common to mature injectable uterotonics:

• Modest volume growth linked to births and hospital deliveries.
• Continued pricing pressure due to generic entrants and tender-based procurement.
• Limited revenue lift without meaningful formulation breakthroughs or new labeled expansions.

A reasonable directional model for investors is:

• Revenue CAGR is driven primarily by unit volumes and currency effects.
• Real growth (in constant terms) is typically limited by pricing convergence.

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How should investors and R&D leaders model risk and upside?

Upside scenarios depend on operational levers rather than blockbuster clinical readouts:

• Formulary penetration improvements in postpartum hemorrhage bundles.
• Better supply continuity that wins tender awards.
• Regional pipeline re-tenders that shift share toward reliable generic suppliers.

Downside scenarios are also operational:

• Severe tender price compression.
• Supply interruptions from API or sterile manufacturing constraints.
• Increased substitution away from ergot uterotonics due to evolving protocols.

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Patent and exclusivity context (implications for commercialization)

Methergine and methylergometrine are not typically positioned as a patent-driven growth asset in the modern era. Commercial strategies therefore tend to rely on:

• Generic manufacturing scale and cost leadership
• Portfolio bundling with other obstetric injectables
• Contract manufacturing and supply reliability
• Local regulatory maintenance and pharmacovigilance discipline

This profile aligns with the absence of a visible, brand-renewal clinical program designed to extend exclusivity through new registrational endpoints.

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Key Takeaways

• Clinical pipeline signal is low: methylergometrine is a mature postpartum uterotonic with no clearly visible new registrational Phase 3 “Methergine” program driving imminent label expansion.
• Market growth is procurement-led: demand is anchored in hospital obstetrics workflows, with revenue performance dominated by tender cycles and generic pricing.
• Mid-term outlook is steady but price-constrained: projection is modest volume-driven growth with continued pricing pressure unless a formulation or supply-driven market share gain occurs.
• Competitive positioning is operational: supply reliability, tender cost, dose-form equivalence, and protocol fit determine share more than differentiated clinical efficacy narratives.

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FAQs

Is Methergine still actively studied in clinical trials?

Most visible activity is historical or small studies tied to postpartum use, formulation, or protocol outcomes, with limited evidence of a current large Phase 3 or brand-led registrational push.

What drives demand for methylergometrine in hospitals?

Postpartum hemorrhage and uterine bleeding management protocols, plus procurement cycles for injectable uterotonics stocked for labor and delivery.

What are the main competitive threats to Methergine revenue?

Generic price compression, tender substitution, and guideline-driven preference shifts toward other uterotonics.

Can a new formulation restart growth?

A new route or delivery system can change competitive dynamics if it improves administration practicality or safety handling, but there is no clear, active registrational program signal in the public trial landscape for methylergometrine.

How should investors approach projections for a mature ergot uterotonic?

Use a model dominated by unit volume drivers (births and delivery rates) and pricing convergence from generics and tendering, with sensitivity to supply continuity and formulary changes.

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References

[1] World Health Organization. WHO recommendations for the prevention and treatment of postpartum haemorrhage. World Health Organization; 2012.
[2] FDA. Oxytocic drugs and related uterotonic safety and efficacy information in obstetric hemorrhage contexts (drug class labeling and safety framework). U.S. Food and Drug Administration.
[3] EMA. Product information and assessments for uterotonic ergot alkaloid class drugs in Europe (methylergometrine and related products). European Medicines Agency.
[4] ClinicalTrials.gov. Methylergometrine (search results for interventional studies). U.S. National Library of Medicine.
[5] PubMed. Methylergometrine postpartum uterine bleeding and uterotonic comparative studies (bibliographic record set). National Library of Medicine.