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Alprostadil

Generic Name
Alprostadil
Brand Names
Caverject, Edex, Muse, Prostin Vr
Drug Type
Small Molecule
Chemical Formula
C20H34O5
CAS Number
745-65-3
Unique Ingredient Identifier
F5TD010360
Background

Alprostadil is a chemically-identical synthetic form of prostaglandin E1 (PGE1), a potent vasodilator produced endogenously. In 1996, the FDA approved the use of alprostadil, administered either with an intracavernosal injection or an intraurethral suppository, for the treatment of erectile dysfunction, and it is used in men for whom oral treatment is either contraindicated or ineffective. After administration, alprostadil promotes smooth muscle relaxation of the corpus cavernosal.

Alprostadil is also used in neonatal patients with congenital heart defects that depend on a patent ductus for survival until corrective or palliative surgery can be performed. This drug causes vasodilation by directly affecting vascular and ductus arteriosus (DA) smooth muscle, preventing or reversing the functional closure of the DA that occurs shortly after birth. This results in increased pulmonary or systemic blood flow in infants.

Indication

Alprostadil is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. It is also indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology, and as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

Associated Conditions
Erectile Dysfunction, Patent Ductus Arteriosus (PDA), Raynaud's Phenomenon
Associated Therapies
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Efficacy, Safety and Satisfaction of VITAROS (Transdermal Topical Alprostadil) in Men With Erectile Dysfunction

Phase 4
Withdrawn
Conditions
Erectile Dysfunction
Interventions
First Posted Date
2013-01-28
Last Posted Date
2014-03-04
Lead Sponsor
Lawson Health Research Institute
Registration Number
NCT01776320
Locations
🇨🇦

St. Joseph's Health Care London, London, Ontario, Canada

The Use of Prostaglandin E1 in Head and Neck Microsurgery

Phase 4
Conditions
Microsurgery
Head and Neck
Prostaglandin E1
Thrombosis
Complications
Interventions
First Posted Date
2008-08-13
Last Posted Date
2009-10-27
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
242
Registration Number
NCT00733434
Locations
🇨🇳

National taiwan University Hospital, Taipei, Taiwan

ALP-1 Continuous Intravenous Infusion to Maintain Clinical Stability in Advanced Heart Failure

Phase 3
Not yet recruiting
Conditions
Heart Failure
Interventions
First Posted Date
2008-02-07
Last Posted Date
2023-05-16
Lead Sponsor
Biopeutics Co., Ltd
Target Recruit Count
1500
Registration Number
NCT00610051
Locations
🇦🇹

Medical university Vienna, Vienna, Austria

Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV

Phase 4
Completed
Conditions
Peripheral Arterial Occlusive Disease
Interventions
Other: Placebo
Drug: Alprostadil
First Posted Date
2008-01-17
Last Posted Date
2018-04-04
Lead Sponsor
UCB BIOSCIENCES GmbH
Target Recruit Count
840
Registration Number
NCT00596752
Locations
🇨🇿

414, Usti Nad Labem, Czechia

🇨🇿

404, Plzen, Czechia

🇲🇽

505, Merida, Mexico

and more 75 locations

ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer

Phase 3
Terminated
Conditions
Prostate Cancer
Stage II Prostate Cancer
Male Erectile Disorder
Stage I Prostate Cancer
Interventions
Drug: sildenafil citrate
Drug: alprostadil
Procedure: robotic-assisted laparoscopic surgery
Procedure: quality-of-life assessment
Other: questionnaire administration
First Posted Date
2007-10-16
Last Posted Date
2019-01-02
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
110
Registration Number
NCT00544076
Locations
🇺🇸

City of Hope, Duarte, California, United States

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