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| Sponsor: | Chulalongkorn University |
|---|---|
| Collaborators: |
Ramathibodi Hospital Siriraj Hospital |
| Information provided by: | Chulalongkorn University |
| ClinicalTrials.gov Identifier: | NCT00421460 |
Purpose
The purpose of this study is to evaluate the response of a treatment with testosterone undecanoate and determine the levels of total and free testosterone in hypogonadal patients with erectile dysfunction.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypogonadism Erectile Dysfunction |
Drug: Testosterone undecanoate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase IV Study of The Therapy of Long-Acting Testosterone Undecanoate,1000mg in 4 ml Oily Solution for i.m.Injection(Nebido) as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction |
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | January 2009 |
Hypogonadism is a pathophysiologic and clinical factor in a substantial number of patients with ED,and data indicate that a threshold level of testosterone is necessary for normal erectile function.Testosterone therapy is clearly indicated in hypogonadal patients and is beneficial in other patients with ED and hypogonadism.However,testosterone efficacy as monotherapy for ED could be limited,and combination therapy with testosterone and other ED treatments,such as PDE-5 inhibitors may be valuable in certain subpopulations of patients.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Concomitant Medication:
Contacts and Locations| Contact: Apichat Kongkanand, Professor | +66 02 2564568 | kongkanand@yahoo.com |
| Thailand | |
| King Chulalongkorn Memorial Hospital | Recruiting |
| Bangkok, Thailand, 10330 | |
| Contact: Apichat Kongkanand, Prof. +66 02 2564568 kongkanand@yahoo.com | |
| Principal Investigator: Apichat Kongkanand, Prof. | |
| Thailand, Bangkok | |
| Ramathibodi Hospital | Recruiting |
| Rajthevee, Bangkok, Thailand, 10400 | |
| Contact: Krisada Ratana-olarn, Professor +66 02 2011315 rakrt@mahidol.ac.th | |
| Principal Investigator: Krisada Ratana-olarn, Professor | |
| Sub-Investigator: Sompol Permpongkosol, M.D. | |
| Siriraj Hospital | Recruiting |
| Bangkoknoi, Bangkok, Thailand, 10700 | |
| Contact: Anupan Tantiwong, Assoc Prof. +66 02 419 7000 ext 8010 siatt@mahidol.ac.th | |
| Principal Investigator: Anupan Tantiwong, Assoc Prof. | |
| Principal Investigator: | Apichat Kongkanand, Professor | King Chulalongkorn Memmorial Hospital |
More Information
| Study ID Numbers: | TH 023101 |
| Study First Received: | January 11, 2007 |
| Last Updated: | January 11, 2007 |
| ClinicalTrials.gov Identifier: | NCT00421460 History of Changes |
| Health Authority: | Thailand: Thai Food and Drug Administration, Ministry of Public Health |
|
Nebido in hypogonadism with erectile dysfunction |
|
Sexual Dysfunctions, Psychological Antineoplastic Agents, Hormonal Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Methyltestosterone Genital Diseases, Male Hormones Sexual and Gender Disorders |
Pharmacologic Actions Testosterone 17 beta-cypionate Anabolic Agents Testosterone Hypogonadism Sexual Dysfunction, Physiological Mental Disorders Therapeutic Uses Erectile Dysfunction Androgens |