CLINICAL TRIALS PROFILE FOR OXYTOCIN 20 USP UNITS IN DEXTROSE 5%

All Clinical Trials for Oxytocin 20 Usp Units In Dextrose 5%

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004363 ↗	Study of the Pathogenesis and Pathophysiology of Familial Neurohypophyseal Diabetes Insipidus	Completed	Northwestern University		1995-12-01	OBJECTIVES: I. Determine whether diverse mutations of the vasopressin-neurophysin II (AVP-NPII) gene cause autosomal dominant familial neurohypophyseal diabetes insipidus by directing the production of an abnormal preprohormone. II. Determine whether the AVP-NPII gene-directed preprohormone accumulates and destroys magnocellular neurons because it cannot be folded and processed efficiently.
NCT00004363 ↗	Study of the Pathogenesis and Pathophysiology of Familial Neurohypophyseal Diabetes Insipidus	Completed	National Center for Research Resources (NCRR)		1995-12-01	OBJECTIVES: I. Determine whether diverse mutations of the vasopressin-neurophysin II (AVP-NPII) gene cause autosomal dominant familial neurohypophyseal diabetes insipidus by directing the production of an abnormal preprohormone. II. Determine whether the AVP-NPII gene-directed preprohormone accumulates and destroys magnocellular neurons because it cannot be folded and processed efficiently.
NCT00107874 ↗	Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-scheduled Cesarean Section	Completed	Basel Women’s University Hospital	Phase 2	1999-01-01	Postpartum hemorrhage (PPH) ranks among the leading causes of maternal morbidity and mortality, both in developed and developing countries. With this trial, we sought to determine the effectiveness of oral misoprostol as an uterotonic drug in comparison with intravenous oxytocin, in patients with a low risk of PPH undergoing non-scheduled Cesarean section. We therefore compared the intra- and postoperative blood loss, as well as drug related side effects in patients, treated by the same surgical and anesthesiological team in one institution.
NCT00107874 ↗	Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-scheduled Cesarean Section	Completed	University Hospital, Basel, Switzerland	Phase 2	1999-01-01	Postpartum hemorrhage (PPH) ranks among the leading causes of maternal morbidity and mortality, both in developed and developing countries. With this trial, we sought to determine the effectiveness of oral misoprostol as an uterotonic drug in comparison with intravenous oxytocin, in patients with a low risk of PPH undergoing non-scheduled Cesarean section. We therefore compared the intra- and postoperative blood loss, as well as drug related side effects in patients, treated by the same surgical and anesthesiological team in one institution.

Clinical Trial Conditions for Oxytocin 20 Usp Units In Dextrose 5%

Condition Name

Condition Name for Oxytocin 20 Usp Units In Dextrose 5%
Intervention	Trials
Postpartum Hemorrhage	85
Healthy	55
Schizophrenia	30
Oxytocin	21

Condition MeSH

Condition MeSH for Oxytocin 20 Usp Units In Dextrose 5%
Intervention	Trials
Hemorrhage	161
Postpartum Hemorrhage	142
Disease	37
Schizophrenia	33

Clinical Trial Locations for Oxytocin 20 Usp Units In Dextrose 5%

Trials by Country

Trials by Country for Oxytocin 20 Usp Units In Dextrose 5%
Location	Trials
United States	366
Egypt	87
Canada	64
China	49
France	34

Trials by US State

Trials by US State for Oxytocin 20 Usp Units In Dextrose 5%
Location	Trials
California	61
North Carolina	33
New York	31
Massachusetts	29
South Carolina	20

Clinical Trial Progress for Oxytocin 20 Usp Units In Dextrose 5%

Clinical Trial Phase

Clinical Trial Phase for Oxytocin 20 Usp Units In Dextrose 5%
Clinical Trial Phase	Trials
Phase 4	129
Phase 3	66
Phase 2/Phase 3	17

Clinical Trial Status

Clinical Trial Status for Oxytocin 20 Usp Units In Dextrose 5%
Clinical Trial Phase	Trials
Completed	391
Recruiting	118
Unknown status	97

Clinical Trial Sponsors for Oxytocin 20 Usp Units In Dextrose 5%

Sponsor Name

Sponsor Name for Oxytocin 20 Usp Units In Dextrose 5%
Sponsor	Trials
University of Electronic Science and Technology of China	40
Samuel Lunenfeld Research Institute, Mount Sinai Hospital	29
Cairo University	24

Sponsor Type

Sponsor Type for Oxytocin 20 Usp Units In Dextrose 5%
Sponsor	Trials
Other	1000
Industry	52
NIH	39

Oxytocin 20 USP Units in Dextrose 5%: Clinical Trials, Market Analysis, and Projections

Introduction

Oxytocin, a synthetic version of the natural hormone produced by the human body, has been widely used in medical settings for various purposes, including inducing labor and managing postpartum bleeding. This article focuses on the specific formulation of Oxytocin 20 USP Units in Dextrose 5%, exploring its current clinical trials, market analysis, and future projections.

Clinical Uses of Oxytocin

Oxytocin is primarily used to induce or strengthen uterine contractions during labor and to control postpartum bleeding. It is also used in other medical contexts, such as treating certain types of infertility and aiding in the management of lactation[5].

Clinical Trials Involving Oxytocin

Enhancing Prolonged Exposure Therapy for PTSD

One notable clinical trial involves the use of oxytocin to enhance prolonged exposure therapy for post-traumatic stress disorder (PTSD). Led by Principal Investigator Julianne Flanagan, this study aims to determine whether oxytocin can improve the efficacy of prolonged exposure therapy. The trial, funded by the Department of Veterans Affairs, runs from March 2020 to August 2025 and has a FY 2025 funding amount of $125,401[1].

Intranasal Oxytocin Augmentation of Brief Couples Therapy

Another significant trial is a randomized clinical trial examining the intranasal oxytocin augmentation of brief couples therapy for veterans with PTSD. Led by Principal Investigator Leslie A. Morland, this study is conducted at the San Diego VA Medical Center and is funded from May 2024 to April 2028 with a FY 2025 funding amount of $318,161. This trial explores the potential benefits of oxytocin in improving relationship outcomes for couples affected by PTSD[4].

FDA Approval and Safety

The FDA has determined that oxytocin products, including those in Dextrose 5%, were not withdrawn from the market for reasons of safety or effectiveness. This determination allows for the approval of abbreviated new drug applications (ANDAs) for these products, provided all other legal and regulatory requirements are met[2].

Market Analysis

Current Market Status

Oxytocin products, including the formulation of 20 USP Units in Dextrose 5%, are widely available and have been a staple in obstetric and gynecologic care for decades. The market is dominated by established pharmaceutical companies, and the product is often used in hospitals and clinical settings.

Pricing and Cost

The cost of oxytocin formulations can vary based on the concentration and volume. For example, oxytocin 20 units in 1000 mL of Dextrose 5% solution is priced competitively, with costs ranging from $0.03 to $0.06 per milliliter, depending on the supplier and the specific formulation[5].

Market Trends

The demand for oxytocin is expected to remain stable due to its essential role in obstetric care. However, advancements in medical technology and the development of new therapeutic uses, such as in the treatment of PTSD, could expand the market for oxytocin products.

Future Projections

Therapeutic Expansion

The potential therapeutic expansion of oxytocin into areas such as PTSD treatment and couples therapy could significantly impact the market. Successful clinical trials could lead to increased demand and new market opportunities for oxytocin formulations.

Regulatory Environment

The FDA's determination that oxytocin products were not withdrawn for safety or effectiveness reasons ensures a stable regulatory environment. This stability is crucial for manufacturers and distributors, allowing them to plan for long-term market presence.

Competitive Landscape

The competitive landscape for oxytocin products is expected to remain competitive, with multiple manufacturers offering various formulations. The entry of generic versions, facilitated by FDA approvals of ANDAs, could further diversify the market and potentially reduce costs.

Key Takeaways

• Clinical Trials: Oxytocin is being explored in new therapeutic areas, including PTSD treatment and couples therapy, which could expand its market.
• FDA Approval: The FDA has confirmed that oxytocin products were not withdrawn for safety or effectiveness reasons, ensuring a stable regulatory environment.
• Market Analysis: The market for oxytocin is stable, with a consistent demand driven by its essential role in obstetric care.
• Future Projections: The potential for therapeutic expansion and the entry of generic versions are key factors that could influence the future market for oxytocin.

FAQs

What is the primary use of Oxytocin 20 USP Units in Dextrose 5%?

The primary use of Oxytocin 20 USP Units in Dextrose 5% is to induce or strengthen uterine contractions during labor and to control postpartum bleeding.

Are there any ongoing clinical trials involving oxytocin?

Yes, there are ongoing clinical trials involving oxytocin, including studies to enhance prolonged exposure therapy for PTSD and to augment brief couples therapy for veterans with PTSD.

Has the FDA approved oxytocin products for safety and effectiveness?

The FDA has determined that oxytocin products, including those in Dextrose 5%, were not withdrawn from the market for reasons of safety or effectiveness.

What is the current market status of oxytocin products?

The market for oxytocin products is stable, with a consistent demand driven by their essential role in obstetric care.

What are the potential future projections for the market of oxytocin products?

The potential therapeutic expansion into new areas and the entry of generic versions could expand the market and influence future demand for oxytocin products.

Sources

1. Office of Research & Development, "Enhancing Prolonged Exposure Therapy for PTSD with Oxytocin," Funded Project Details - FY2025.
2. Federal Register, "Determination That OXYTOCIN in 5% Dextrose Injection Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness," Vol. 80, No. 77, Wednesday, April 22, 2015.
3. ClinicalTrials.gov, "PROTOCOL GOG-0281 Lead Organization," [PDF].
4. Office of Research & Development, "A Randomized Clinical Trial Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans with PTSD," Funded Project Details - FY2025.
5. DrugBank Online, "Oxytocin: Uses, Interactions, Mechanism of Action."