The Therapy of Nebido as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction
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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 or disease
Drug: Testosterone Undecanoate,1000mg
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.
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
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
Nitrites or Nitric oxide donors
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.