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

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction; Hypogonadism
• Intervention / Treatment: Drug: Testosterone Undecanoate,1000mg

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.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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Siriraj Hospital
    • Rajthevee, Bangkok, Thailand, 10400
      • Ramathibodi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Patients with ED over 3 months (specify using IIEF score)
2. Age >= 18 years.
3. Stable sexual relationship
4. With low or low normal serum testosterone level (either total or bioavailable testosterone) TT <= 4 ng/ml and/or BT <= 1 ng/ml
5. Aging Male Symptom scale with total score starting at 37 points (must not replace TT < 4 ng/ml)
6. Eligible subjects who previously took the oral androgen or PDE5 inhibitor must have discontinued their use for 1 month

Exclusion Criteria:

1. Contraindication to treatment with Testosterone according to the SPC
2. Hypersensitivity to the active substances or any of the excipients of Nebido
3. Diagnosed or suspected carcinoma of the prostate or the male breast cancer
4. Past or present liver tumors
5. Acute or chronic hepatic diseases
6. Severe cardiac, hepatic or renal insufficiency
7. History of penile implant or significant penile deformity
8. Diagnosed sleep apnea
9. Polycythemia (Hematocrit >50%)
10. Prolactin >25 ng/ml
11. Organic hypothalamic-pituitary pathology
12. Any unstable medical, psychiatric or drug/alcohol abuse disorder
13. Prostate specific antigen (PSA)>= 4 ng/ml
14. Severe symptomatic benign prostatic hyperplasia (IPSS) sum score >=20)
15. Diabetes mellitus which is uncontrolled (HbAlc level >10%)
16. Epilepsy not adequately controlled by treatment
17. Patients requiring fertility treatment
18. Hypertension which is not adequately controlled on therapy
19. Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma or leukemia
20. Hypersensitivity to PDE-5 inhibitors

21. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Testosterone level	at 6,12,18,36,46 weeks

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Collaborators: Ramathibodi Hospital; Siriraj Hospital
• Investigators: Principal Investigator: Apichat Kongkanand, Professor, King Chulalongkorn Memmorial Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (ACTUAL): January 1, 2011
• Study Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: January 11, 2007
• First Submitted That Met QC Criteria: January 11, 2007
• First Posted (ESTIMATE): January 12, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): May 15, 2012
• Last Update Submitted That Met QC Criteria: May 14, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Nebido in hypogonadism with erectile dysfunction
• Additional Relevant MeSH Terms: Mental Disorders; Endocrine System Diseases; Gonadal Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Hypogonadism; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: TH 023101