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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR METHERGINE


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

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
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Condition MeSH

Condition MeSH for Methergine
Intervention Trials
Hemorrhage 7
Postpartum Hemorrhage 4
Uterine Inertia 2
Pregnancy Complications 1
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Clinical Trial Locations for Methergine

Trials by Country

Trials by Country for Methergine
Location Trials
United States 6
Egypt 2
Lebanon 1
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Trials by US State

Trials by US State for Methergine
Location Trials
New York 2
Iowa 1
Maryland 1
California 1
Florida 1
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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
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Clinical Trial Status

Clinical Trial Status for Methergine
Clinical Trial Phase Trials
Completed 5
Recruiting 1
Unknown status 1
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Clinical Trial Sponsors for Methergine

Sponsor Name

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

Sponsor Type for Methergine
Sponsor Trials
Other 10
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Methergine (Methylergonovine Maleate): Clinical Trials, Market Analysis, and Projections

Introduction

Methergine, also known as methylergonovine maleate, is a semi-synthetic ergot alkaloid widely used in the medical field for the prevention and control of postpartum hemorrhage and other uterine-related conditions. Here, we will delve into the current status of clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Development Status

Methergine has a long history of use, with its first approval in the United States dating back to November 1946. It has successfully completed all necessary clinical trials globally and is approved for use in various countries[1][2][4].

  • Global Approval: Methergine has been approved globally for its efficacy and safety in managing uterine atony, hemorrhage, and subinvolution of the uterus.
  • China: The drug is currently in Phase 3 clinical trials in China, indicating it is in the advanced stages of clinical testing in this region[1].

Mechanism of Action and Clinical Use

Methergine acts directly on the smooth muscle of the uterus, increasing the tone, rate, and amplitude of rhythmic contractions. This action induces a rapid and sustained tetanic uterotonic effect, which is crucial for shortening the third stage of labor and reducing blood loss[2][4][5].

  • Indications: The primary indications include routine management of uterine atony, hemorrhage, and subinvolution of the uterus following delivery of the placenta, as well as control of uterine hemorrhage in the second stage of labor[2][4].

Pharmacokinetics

The pharmacokinetic profile of Methergine is well-defined:

  • Bioavailability: The bioavailability after oral administration is about 60%, increasing to 78% with intramuscular injection. The drug is rapidly distributed from plasma to peripheral tissues within 2-3 minutes[2][4][5].
  • Elimination: Methergine is eliminated primarily through hepatic metabolism and excretion, with a mean elimination half-life of 3.39 hours[2][4].

Market Analysis

Current Market

The market for drugs like Methergine is part of a broader pharmaceutical landscape that includes treatments for various urogenital diseases and postpartum complications.

  • Global Demand: The demand for effective treatments for postpartum hemorrhage and other uterine-related conditions remains high, driven by the need for safe and reliable medications in obstetric care[1][2].

Market Projections

While specific market projections for Methergine alone are not readily available, the overall market for obstetric medications is expected to grow:

  • Growth Drivers: The integration of advanced technologies, such as artificial intelligence and machine learning in clinical trials, is expected to enhance the efficiency and accuracy of drug development. This could indirectly benefit the market for drugs like Methergine by improving the overall quality and speed of clinical trials[3].

Competitive Landscape

The pharmaceutical market for ergot alkaloids and related drugs is competitive, with several major players involved:

  • Key Players: Companies like Pfizer Inc., Eli Lilly & Co., and Alkermes Plc are actively involved in the development of drugs targeting similar indications, including Parkinson's disease, schizophrenia, and hypertension. These companies have diverse portfolios of drugs in various stages of development[1].

Future Projections

Technological Advancements

The future of Methergine and similar drugs will be influenced by technological advancements in clinical trial imaging and data analysis:

  • AI and Machine Learning: The integration of AI and machine learning in clinical trials is expected to revolutionize data interpretation, leading to faster trial completion times and more reliable results. This could expedite the development and approval of new drugs in the same therapeutic class[3].

Regulatory Environment

The regulatory environment will continue to play a crucial role in the approval and use of Methergine:

  • Regulatory Compliance: Ensuring compliance with evolving regulatory standards will be essential for maintaining market presence and expanding into new regions[4].

Emerging Markets

Emerging markets, particularly in regions like China, will be significant for the future growth of Methergine:

  • China: The ongoing Phase 3 clinical trials in China indicate potential for significant market expansion in this region once the drug is approved[1].

Key Takeaways

  • Clinical Trials: Methergine has completed all necessary clinical trials globally and is in Phase 3 trials in China.
  • Mechanism of Action: It acts directly on the smooth muscle of the uterus to increase tone, rate, and amplitude of contractions.
  • Market Analysis: The market for obstetric medications is expected to grow, driven by technological advancements and increasing demand.
  • Future Projections: Technological advancements, regulatory compliance, and expansion into emerging markets will shape the future of Methergine.

FAQs

What is Methergine used for?

Methergine is used for the prevention and control of postpartum hemorrhage, uterine atony, and subinvolution of the uterus following delivery of the placenta[2][4].

How does Methergine work?

Methergine acts directly on the smooth muscle of the uterus, increasing the tone, rate, and amplitude of rhythmic contractions, thereby inducing a rapid and sustained tetanic uterotonic effect[2][4][5].

What is the bioavailability of Methergine?

The bioavailability of Methergine is about 60% after oral administration and 78% after intramuscular injection[2][4][5].

What are the common side effects of Methergine?

Common side effects include nausea, vomiting, and increased blood pressure. Rare but serious side effects can include cerebrovascular accidents, ventricular fibrillation, and anaphylaxis[4].

Is Methergine approved globally?

Yes, Methergine has been approved globally for its therapeutic use, although it is currently in Phase 3 clinical trials in China[1][2][4].

Sources

  1. Synapse Patsnap: Exploring Methylergonovine Maleate's Revolutionary R&D Successes.
  2. Drugs.com: Methergine: Package Insert / Prescribing Information.
  3. CMRAD: Clinical Trial Imaging Market: Size, Growth Analysis & Forecast 2024-2029.
  4. FDA: Approval Package for Methergine (methylergonovine maleate tablet and injection).
  5. DrugBank: Methylergometrine: Uses, Interactions, Mechanism of Action.

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