The Therapy of Nebido as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction
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
1 other identifier
interventional
30
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2007
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 11, 2007
CompletedFirst Posted
Study publicly available on registry
January 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedMay 15, 2012
May 1, 2012
4 years
January 11, 2007
May 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response of treatment for 4 injections at 1 year; score on an IIEF-5
4 injections at 1 year for each subject, at 12,30,46 weeks.
Secondary Outcomes (1)
Testosterone level
at 6,12,18,36,46 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Patients with ED over 3 months (specify using IIEF score)
- Age \>= 18 years.
- Stable sexual relationship
- With low or low normal serum testosterone level (either total or bioavailable testosterone) TT \<= 4 ng/ml and/or BT \<= 1 ng/ml
- Aging Male Symptom scale with total score starting at 37 points (must not replace TT \< 4 ng/ml)
- Eligible subjects who previously took the oral androgen or PDE5 inhibitor must have discontinued their use for 1 month
You may not qualify if:
- Contraindication to treatment with Testosterone according to the SPC
- Hypersensitivity to the active substances or any of the excipients of Nebido
- Diagnosed or suspected carcinoma of the prostate or the male breast cancer
- Past or present liver tumors
- Acute or chronic hepatic diseases
- Severe cardiac, hepatic or renal insufficiency
- History of penile implant or significant penile deformity
- Diagnosed sleep apnea
- Polycythemia (Hematocrit \>50%)
- Prolactin \>25 ng/ml
- Organic hypothalamic-pituitary pathology
- Any unstable medical, psychiatric or drug/alcohol abuse disorder
- Prostate specific antigen (PSA)\>= 4 ng/ml
- Severe symptomatic benign prostatic hyperplasia (IPSS) sum score \>=20)
- Diabetes mellitus which is uncontrolled (HbAlc level \>10%)
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chulalongkorn Universitylead
- Ramathibodi Hospitalcollaborator
- Siriraj Hospitalcollaborator
Study Sites (3)
Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
Ramathibodi Hospital
Rajthevee, Bangkok, 10400, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Apichat Kongkanand, Professor
King Chulalongkorn Memmorial Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2007
First Posted
January 12, 2007
Study Start
January 1, 2007
Primary Completion
January 1, 2011
Study Completion
May 1, 2011
Last Updated
May 15, 2012
Record last verified: 2012-05