HypogonadismPhase 4NCT00421460
The Therapy of Nebido as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction
A Phase 4 study testing Testosterone Undecanoate,1000mg in people with Hypogonadism and Erectile Dysfunction, run by Chulalongkorn University at 3 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypogonadism, Erectile Dysfunction
- What is being tested?
- Testosterone Undecanoate,1000mg
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 3 sitesThailand
- Study dates
- Jan 2007to May 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Siriraj Hospital
Bangkoknoi, Bangkok, 10700
Ramathibodi Hospital
Rajthevee, Bangkok, 10400
About this study
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
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.
Read the 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.
- Conditions
- Hypogonadism, Erectile Dysfunction
- Being tested
- Testosterone Undecanoate,1000mg
- Keywords
- Nebido in hypogonadism with erectile dysfunction
- Medical subject headings
- Hypogonadism, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Undecanoate,1000mgDrug
Also called Nebido 1000 mg
duration for 4 injections
What is being measured
The primary outcome is the main question the study is designed to answer.
Response of treatment for 4 injections at 1 year; score on an IIEF-5
Measured: 4 injections at 1 year for each subject, at 12,30,46 weeks.
Secondary outcomes (1)
Testosterone level
Measured: at 6,12,18,36,46 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionJan 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Ramathibodi Hospital, Siriraj Hospital
- Responsible party
- Sponsor
- Investigators
- Apichat Kongkanand, Professor, Principal investigator, King Chulalongkorn Memmorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421460
- Sponsor's protocol ID
- TH 023101
- Status last verified
- May 2012
- First submitted
- 11 Jan 2007
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00421460
- Acronym / sponsor ID
- TH 023101
- Conditions
- Hypogonadism, Erectile Dysfunction
- Keywords
- Nebido in hypogonadism with erectile dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Ramathibodi Hospital, Siriraj Hospital
- Study start
- Jan 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 12 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone Undecanoate,1000mgAlso: Nebido 1000 mgduration for 4 injections | Drug | – |
Primary outcome
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.
1 secondary outcome
Testosterone level
Time frame: at 6,12,18,36,46 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Apichat Kongkanand, Professor principal investigator
King Chulalongkorn Memmorial Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone Undecanoate,1000mg in people with Hypogonadism and Erectile Dysfunction, run by Chulalongkorn University at 3 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2012.