CLINICAL TRIALS PROFILE FOR ALPROSTADIL

All Clinical Trials for Alprostadil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00248209 ↗	Female Orgasmic Disorder (FOD) and Wellbutrin XL	Completed	GlaxoSmithKline	Phase 2/Phase 3	2004-05-01	A recently completed multi-site double-blind placebo-controlled study found that bupropion (Wellbutrin XL) increased female orgasmic function in a group of pre-menopausal women with a diagnosis of hypoactive sexual desire disorder. The purpose of this study is to ascertain whether bupropion will improve orgasmic function in pre-menopausal women with a primary complaint of idiopathic orgasmic disorder who do not have hypoactive sexual desire disorder. This will be a multicenter, placebo-controlled, double blind study of women with a diagnosis of female orgasm disorder. During a baseline visit, psychiatric, medical, alcohol and drug, and sexual histories will be obtained. Patients who continue to meet screening inclusion/exclusion criteria at their baseline visit will be randomly assigned to either placebo or bupropion XL for 8 weeks. A flexible dosing paradigm will be used. Sexual desire and activity will be assessed by patient diaries, investigator interview of sexual functioning every two weeks, and by standardized questionnaire every four weeks. The primary endpoint will be the increase in orgasm completion as measured by the Changes in Sexual Functioning Questionnaire-F (CSFQ-F). Secondary endpoints will be changes in sexual arousal, sexual desire, and sexual pleasure as assessed by the CSFQ-F.
NCT00248209 ↗	Female Orgasmic Disorder (FOD) and Wellbutrin XL	Completed	Segraves, R., T., M.D., Ph.D.	Phase 2/Phase 3	2004-05-01	A recently completed multi-site double-blind placebo-controlled study found that bupropion (Wellbutrin XL) increased female orgasmic function in a group of pre-menopausal women with a diagnosis of hypoactive sexual desire disorder. The purpose of this study is to ascertain whether bupropion will improve orgasmic function in pre-menopausal women with a primary complaint of idiopathic orgasmic disorder who do not have hypoactive sexual desire disorder. This will be a multicenter, placebo-controlled, double blind study of women with a diagnosis of female orgasm disorder. During a baseline visit, psychiatric, medical, alcohol and drug, and sexual histories will be obtained. Patients who continue to meet screening inclusion/exclusion criteria at their baseline visit will be randomly assigned to either placebo or bupropion XL for 8 weeks. A flexible dosing paradigm will be used. Sexual desire and activity will be assessed by patient diaries, investigator interview of sexual functioning every two weeks, and by standardized questionnaire every four weeks. The primary endpoint will be the increase in orgasm completion as measured by the Changes in Sexual Functioning Questionnaire-F (CSFQ-F). Secondary endpoints will be changes in sexual arousal, sexual desire, and sexual pleasure as assessed by the CSFQ-F.
NCT00314548 ↗	Inhaled Prostacyclin for Adult Respiratory Distress Syndrome (ARDS) and Pulmonary Hypertension	Completed	Medical Research Council, Pakistan	N/A	2006-05-01	Summary of the proposed research: The intravenous application of prostacyclin (PGE1) or its stable analogue, iloprost, has been used to cause a decrease not only of the pulmonary but also of the systemic vascular tone. Aerosolized prostacyclin, on the other hand, can result in a selective pulmonary vasodilatation without affecting the systemic blood pressure as shown in preliminary studies/case reports. No large trials exist for this type of use of the drug so far. Furthermore, aerosolized PGI2 can improve gas exchange and pulmonary shunt in clinical settings of impaired ventilation/perfusion ratio as it occurs in adult respiratory distress syndrome (ARDS) due to the redistribution of pulmonary blood flow from non-ventilated to ventilated, aerosol accessible lung regions. Therefore, the investigators propose to carry out a prospective, double blinded, randomized trial to show that the nebulized iloprost decreases pulmonary hypertension selectively and improves oxygenation in ARDS.

Clinical Trial Conditions for Alprostadil

Condition Name

Condition Name for Alprostadil
Intervention	Trials
Erectile Dysfunction	5
Drug-induced Liver Injury,Chronic	2
ST Segment Elevation Myocardial Infarction	2

Condition MeSH

Condition MeSH for Alprostadil
Intervention	Trials
Erectile Dysfunction	7
Respiratory Distress Syndrome	3
Sexual Dysfunctions, Psychological	3

Clinical Trial Locations for Alprostadil

Trials by Country

Trials by Country for Alprostadil
Location	Trials
United States	21
China	12
Austria	2
Canada	2
Germany	2

Trials by US State

Trials by US State for Alprostadil
Location	Trials
California	5
Ohio	4
Michigan	2
Maryland	1
Pennsylvania	1

Clinical Trial Progress for Alprostadil

Clinical Trial Phase

Clinical Trial Phase for Alprostadil
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	4
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Alprostadil
Clinical Trial Phase	Trials
Completed	12
Not yet recruiting	10
Unknown status	8

Clinical Trial Sponsors for Alprostadil

Sponsor Name

Sponsor Name for Alprostadil
Sponsor	Trials
Assiut University	3
Beijing 302 Hospital	3
Shanghai 10th People's Hospital	2

Sponsor Type

Sponsor Type for Alprostadil
Sponsor	Trials
Other	36
Industry	13
NIH	1

Clinical Trials, Market Analysis, and Projections for Alprostadil

Introduction to Alprostadil

Alprostadil, a synthetic form of the naturally occurring prostaglandin E1, is widely used in the treatment of erectile dysfunction (ED) and other conditions such as neonatal duct-dependent congenital heart defects. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Clinical Studies Overview

Clinical trials have been instrumental in establishing the efficacy and safety of alprostadil. For instance, studies such as those conducted for CAVERJECT® IMPULSE (alprostadil) have shown significant results:

• In Study 1, involving 153 men with ED, over 80% of patients experienced an erection sufficient for sexual intercourse after intracavernosal injection of alprostadil. The study demonstrated a dose-response relationship, with higher doses leading to higher response rates[4].

• Another study involving 296 men with ED showed that alprostadil doses ranging from 2.5 mcg to 20 mcg were significantly more effective than placebo in inducing erections suitable for intercourse[4].

Adverse Reactions and Safety

While alprostadil has proven effective, it is not without adverse reactions. Common local adverse reactions include penile pain (37%), prolonged erection (4%), and penile fibrosis (3%)[1]. Systemic adverse reactions are less common but can include dizziness (1%)[1].

Comparative Studies

Studies comparing CAVERJECT IMPULSE with the traditional CAVERJECT formulation have shown comparable efficacy, as assessed by the International Index of Erectile Function (IIEF) and physician-assessment scores[4].

Market Analysis

Market Size and Growth

The alprostadil market has experienced significant growth over the years. From 2017 to 2022, the market witnessed an increase in revenue, and it is estimated to continue growing. By 2029, the market is projected to reach a substantial value, driven by a compound annual growth rate (CAGR) that reflects the increasing demand for alprostadil products[2].

Market Segmentation

The alprostadil market is segmented based on type and application:

• Type: The market is primarily split into injection and suppository forms. The injection form, particularly intracavernosal injections, remains a dominant segment due to its direct and effective delivery method[2].

• Application: The market is segmented into hospital and clinic settings. Hospitals are a major segment due to the need for supervised administration and monitoring of alprostadil injections[2].

Regional Analysis

The global alprostadil market is analyzed across various regions, including North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. The Asia-Pacific region, driven by countries like China and India, is emerging as a significant player in the market. Regulatory reforms in China have facilitated faster approval of foreign drug applications, contributing to the region's growth[2].

Impact of Global Events

COVID-19 Pandemic

The COVID-19 pandemic had a mixed impact on the alprostadil market. While there were disruptions in supply chains and consumption patterns, the pandemic also highlighted the importance of healthcare infrastructure and the need for effective treatments. The market analysis includes the impact of COVID-19 on production, consumption, and consumer behavior, providing insights into how the market adapted and is expected to grow post-pandemic[2].

Russia-Ukraine War

The Russia-Ukraine war has introduced additional complexities, affecting global supply chains and economic stability. The market report considers these factors, providing a comprehensive analysis of how these events influence the alprostadil market's growth and stability[2].

Future Projections

Technological Innovations

Technological advancements are expected to optimize the performance of alprostadil products, making them more widely used in various applications. Innovations in delivery systems and formulations will likely enhance patient compliance and treatment outcomes[2].

Market Drivers and Opportunities

The increasing prevalence of chronic diseases, such as erectile dysfunction, and government initiatives supporting clinical trials are key drivers for the alprostadil market. The rise in clinical trials, particularly in the Asia-Pacific region, is expected to further boost the market's growth[2][3].

Competitive Landscape

The alprostadil API market is competitive, with major players including Sanofi, Fukuzyu Pharmaceutical, Shandong Octagon Chemicals, and others. These companies are focusing on expanding their market share through innovative products and strategic partnerships[5].

Key Takeaways

• Efficacy and Safety: Alprostadil has been proven effective in clinical trials, with a significant number of patients achieving erections suitable for intercourse.
• Market Growth: The alprostadil market is projected to grow substantially, driven by increasing demand and technological innovations.
• Regional Impact: The Asia-Pacific region is emerging as a key player, driven by regulatory reforms and increasing clinical trial activity.
• Global Events: The COVID-19 pandemic and the Russia-Ukraine war have introduced complexities, but the market is expected to stabilize and grow in the coming years.

FAQs

What are the common adverse reactions associated with alprostadil?

Common adverse reactions include penile pain, prolonged erection, penile fibrosis, and injection site hematoma or ecchymosis[1].

How is the alprostadil market segmented?

The market is segmented based on type (injection and suppository) and application (hospital and clinic settings)[2].

What is the impact of the COVID-19 pandemic on the alprostadil market?

The pandemic has affected supply chains and consumption patterns but has also highlighted the importance of healthcare infrastructure, leading to adaptations and growth in the market[2].

Which regions are driving the growth of the alprostadil market?

The Asia-Pacific region, particularly China and India, is emerging as a significant driver due to regulatory reforms and increased clinical trial activity[2].

Who are the major players in the alprostadil API market?

Major players include Sanofi, Fukuzyu Pharmaceutical, Shandong Octagon Chemicals, and others[5].

Sources

1. CAVERJECT® IMPULSE (alprostadil) Adverse Reactions - US. Pfizer Medical Information.
2. Alprostadil Market Insights 2024-2032: Fostering your Brand Growth. News Channel Nebraska.
3. Global Clinical Trials Market Size, Top Share, Trends, Forecast by .... Straits Research.
4. CAVERJECT® IMPULSE (alprostadil) Clinical Studies - US. Pfizer Medical Information.
5. Alprostadil API - Market, Report Size, Worth, Revenue, Growth .... Valuates Reports.

Last updated: 2025-01-01