Status:
COMPLETED
The Therapy of Nebido as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction
Lead Sponsor:
Chulalongkorn University
Collaborating Sponsors:
Ramathibodi Hospital
Siriraj Hospital
Conditions:
Hypogonadism
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
PHASE4
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 dysfunc...
Detailed Description
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.Te...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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%)
- Epilepsy not adequately controlled by treatment
- Patients requiring fertility treatment
- Hypertension which is not adequately controlled on therapy
- Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma or leukemia
- Hypersensitivity to PDE-5 inhibitors
- Concomitant Medication:
- Nitrites or Nitric oxide donors
- Anti-androgens
- anti-coagulants, with the exception of anti-platelet agents
- Any of potent inhibitors of cytochrome P-450 3A4:such as HIV protease inhibitors (Ritonavir or Indinavir); Anti-mycotic agent (Itraconazole and Ketoconazole)-topical application allowed; or Erythromycin.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00421460
Start Date
January 1 2007
End Date
May 1 2011
Last Update
May 15 2012
Active Locations (3)
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1
Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
2
Ramathibodi Hospital
Rajthevee, Bangkok, Thailand, 10400
3
King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330