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The Therapy of Nebido as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction

Primary Purpose

Hypogonadism, Erectile Dysfunction

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Testosterone Undecanoate,1000mg

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring Nebido in hypogonadism with erectile dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Siriraj Hospital
Ramathibodi Hospital
King Chulalongkorn Memorial Hospital

Outcomes

Primary Outcome Measures

Response of treatment for 4 injections at 1 year; score on an IIEF-5

Secondary Outcome Measures

Testosterone level

Full Information

NCT ID

NCT00421460

First Posted

January 11, 2007

Last Updated

May 14, 2012

Sponsor

Chulalongkorn University

Collaborators

Ramathibodi Hospital, Siriraj Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00421460

Brief Title

The Therapy of Nebido as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chulalongkorn University

Collaborators

Ramathibodi Hospital, Siriraj Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypogonadism, Erectile Dysfunction

Keywords

Nebido in hypogonadism with erectile dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Testosterone Undecanoate,1000mg

Other Intervention Name(s)

Nebido 1000 mg

Intervention Description

duration for 4 injections

Primary Outcome Measure Information:

Title

Response of treatment for 4 injections at 1 year; score on an IIEF-5

Time Frame

4 injections at 1 year for each subject, at 12,30,46 weeks.

Secondary Outcome Measure Information:

Title

Testosterone level

Time Frame

at 6,12,18,36,46 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Apichat Kongkanand, Professor

Organizational Affiliation

King Chulalongkorn Memmorial Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Siriraj Hospital

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Ramathibodi Hospital

City

Rajthevee

State/Province

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

King Chulalongkorn Memorial Hospital

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

The Therapy of Nebido as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction

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