Erectile DysfunctionPhase 4NebidolocalNCT00555087
Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate
A Phase 4 study testing Testosterone Undecanoate and/or PDE-5 in people with Erectile Dysfunction and Hypogonadotrophic Males, run by Hospital Santa Fe at 4 sites in Mexico.
Trial summary
The main objective of this study is to evaluate the response of erectile dysfunction in hypogonadotrophic males with Testosterone undecanoate i.m. as per IIEF and the question of the GAQ (Global Evaluation Questionnaire) after 42 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction, Hypogonadotrophic Males
- What is being tested?
- Testosterone Undecanoate and/or PDE-5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesMexico
- Study dates
- May 2007to Jan 2008
- 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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years old and younger than 70 years.
- To have diagnosis of erectile dysfunction by IIEF. Qualification less than 46 points and/or GAQ with Answer "NO".
- Patients with Inform consent letter signed.
- Patients without any therapy with other type of testosterone, gonadotrophines and/or PDE-5 in the previous 4 weeks of their inclusion at the study.
- Diagnosis of hypogonadism according to the criteria:
- Testosterone dosage lower than 12 nmol/L
- Free testosterone shall be below 180 pmol/L o 52 pg/mL
Who cannot join
- People less than 18 years old and older than 70 years.
- Patients with history of or with known or suspected sleep apnea.
- Patients who participate in other study protocols
- Known or suspected active systemic infection.
- Patients with HIV + and/ or known HTLV+.
- Patients with hyperprolactinemia
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- Patients with known or suspected coagulopathies
- Patients with Klinefelter
- Known or suspected psychiatric illness.
- Patients who have received prior therapy with some kind of testosterone in the last 4 months or a PDE-5 inhibitor in the last month.
- Patients with contraindications for the use of PDE-5 inhibitors
- Patients having a diagnosis of erectile dysfunction but with total and/ or free testosterone levels within the physiological range.
- Patients with APE ≥ 2.5 ng/ml in younger than 60 years, or > de 3 ng/ml in older than 60 years.
- Abnormal prostate findings during the digital rectal examination (that is to say, irregularities, hard consistency when examined).
- Concomitant malignant diseases or history of prostate cancer
Trial locations and contacts
4 sites in 1 country.
Mexico4 sites, 4 recruiting
- Recruiting
Hospital General de Occidente
Guadalajara, Jalisco, 045040
Arturo Rodriguez, MD, (5235) 87 90 90, aruro2000@yahoo.com
- Not yet recruiting
Hospital General de Occidente
Guadalajara, Jalisco, 44690
Arturo R Rodriguez, MD-Urology, (5255) 333 5879 090, aruro2000@yahoo.com
- Not yet recruiting
Hospital Santa Fe
Mexico City, D.F., 06700
Jorge G Jaspersen, MD-Urology, (5255) 55 64 53 70, jaspersen@prodigy.net.mx
- Not yet recruiting
Hospital Universitario de Nuevo León
Monterrey, Nuevo León, 64460
Lauro G Gomez, MD.Uro-Andro, (52 55 818) 20 44 44, laurogomez@hotmail.com
About this study
Official title: Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate i.m. 1000 mg. A Prospective, Multi-Center Clinical Study Phase IV.
The main objective of this study is to evaluate the response of erectile dysfunction in hypogonadotrophic males with Testosterone undecanoate i.m. as per IIEF and the question of the GAQ (Global Evaluation Questionnaire) after 42 weeks of treatment.
Secondary Study Objectives
- To monitor adverse events and changes in hemoglobin and serum chemistry with: PSA, lipid profile, renal-hepatic profile and glycemia, and control by means of a rectal digital examination.
- To Determinate physiologic reconstitution in patients under treatment by means of total and free testosterone dosage.
Read the detailed description
The importance of testosterone in desire, interest and sexual motivation is well known, but its effects on erectile function continue provoking controversy. Data obtained in animals under experimental or surgical castration, explains how this condition can cause a veno-occlusive dysfunction and therefore an erectile dysfunction. In a model of animal flebogenous erectile dysfunction, the intracavernous vascular endothelial growth factor (VEGF), together with testosterone, reestablishes the balance between the muscle and the conjunctive tissue, hypertrophy and hyperplasia of endothelial cells and regularizes the diameter of dorsal nervous cells, thus preventing the veno-occlusive dysfunction. Castration also induces the apopthosis in the erectile tissue of the penis; the treatment with testosterone provokes a new DNA synthesis.
There are certain indicators that the treatment with testosterone could help patients with erectile dysfunction and low testosterone base line amounts. Likewise, androgens could control the expression and the activity of type 5 phosphodiesterase (PDE-5) of the cavernous body of the penis.
Pharmacological treatment with PDE-5 inhibitors, administered orally fails in certain cases of erectile dysfunction, even more in hypogonadal males. Some studies show that the combination of testosterone with a PDE-5 inhibitor helps the recovery of sexual function in patients; therefore, giving the possibility of a combined pharmacological treatment with testosterone in erectile dysfunction.
- Conditions
- Erectile Dysfunction, Hypogonadotrophic Males
- Being tested
- Testosterone Undecanoate and/or PDE-5
- Keywords
- Erectile dysfunction, Hypogonadotrophic males
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Undecanoate and/or PDE-5Drug
Also called Nebido, Levitra
Testosterone Undecanoate 1000 mg IM injection; PDF5 tab, 20 mg
| Study group | Role | What they receive |
|---|---|---|
| A= Nebido | Experimental | It is and intervention study with 1 arm Receives: Drug: Testosterone Undecanoate and/or PDE-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score higher than or equal to 21 of the erectile dysfunction domain of the IIEF, or response to treatment
Measured: 42 weeks
and/or an affirmative response to the GAQ will be considered for the analysis
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startMay 2007
- Study completionJan 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Santa Fe
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Investigators
- Jorge Jaspersen, MD, Principal investigator, H Santa Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555087
- Sponsor's protocol ID
- 2006/1084
- Acronym
- Nebidolocal
- Status last verified
- Nov 2007
- First submitted
- 5 Nov 2007
- Last updated
- 7 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate i.m. 1000 mg. A Prospective, Multi-Center Clinical Study Phase IV.
- ClinicalTrials.gov ID
- NCT00555087
- Acronym / sponsor ID
- Nebidolocal / 2006/1084
- Conditions
- Erectile Dysfunction, Hypogonadotrophic Males
- Keywords
- Erectile dysfunction, Hypogonadotrophic males
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Santa FeUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- May 2007
- Study completion
- Jan 2008 (estimated)
- First posted
- 7 Nov 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 main objective of this study is to evaluate the response of erectile dysfunction in hypogonadotrophic males with Testosterone undecanoate i.m. as per IIEF and the question of the GAQ (Global Evaluation Questionnaire) after 42 weeks of treatment.
Secondary Study Objectives
- To monitor adverse events and changes in hemoglobin and serum chemistry with: PSA, lipid profile, renal-hepatic profile and glycemia, and control by means of a rectal digital examination.
- To Determinate physiologic reconstitution in patients under treatment by means of total and free testosterone dosage.
Detailed description
The importance of testosterone in desire, interest and sexual motivation is well known, but its effects on erectile function continue provoking controversy. Data obtained in animals under experimental or surgical castration, explains how this condition can cause a veno-occlusive dysfunction and therefore an erectile dysfunction. In a model of animal flebogenous erectile dysfunction, the intracavernous vascular endothelial growth factor (VEGF), together with testosterone, reestablishes the balance between the muscle and the conjunctive tissue, hypertrophy and hyperplasia of endothelial cells and regularizes the diameter of dorsal nervous cells, thus preventing the veno-occlusive dysfunction. Castration also induces the apopthosis in the erectile tissue of the penis; the treatment with testosterone provokes a new DNA synthesis.
There are certain indicators that the treatment with testosterone could help patients with erectile dysfunction and low testosterone base line amounts. Likewise, androgens could control the expression and the activity of type 5 phosphodiesterase (PDE-5) of the cavernous body of the penis.
Pharmacological treatment with PDE-5 inhibitors, administered orally fails in certain cases of erectile dysfunction, even more in hypogonadal males. Some studies show that the combination of testosterone with a PDE-5 inhibitor helps the recovery of sexual function in patients; therefore, giving the possibility of a combined pharmacological treatment with testosterone in erectile dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A= Nebido | Experimental | Drug: Testosterone Undecanoate and/or PDE-5It is and intervention study with 1 arm |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients older than 18 years old and younger than 70 years.
- To have diagnosis of erectile dysfunction by IIEF. Qualification less than 46 points and/or GAQ with Answer "NO".
- Patients with Inform consent letter signed.
- Patients without any therapy with other type of testosterone, gonadotrophines and/or PDE-5 in the previous 4 weeks of their inclusion at the study.
- Diagnosis of hypogonadism according to the criteria:
Key exclusion criteria (15 listed)
- People less than 18 years old and older than 70 years.
- Patients with history of or with known or suspected sleep apnea.
- Patients who participate in other study protocols
- Known or suspected active systemic infection.
- Patients with HIV + and/ or known HTLV+.
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 and/or PDE-5Also: Nebido, LevitraTestosterone Undecanoate 1000 mg IM injection; PDF5 tab, 20 mg | Drug | A= Nebido |
Primary outcome
Score higher than or equal to 21 of the erectile dysfunction domain of the IIEF, or response to treatment
Time frame: 42 weeks
and/or an affirmative response to the GAQ will be considered for the analysis
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2007.
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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.
Jorge Jaspersen, MD principal investigator
H Santa Fe
4 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 and/or PDE-5 in people with Erectile Dysfunction and Hypogonadotrophic Males, run by Hospital Santa Fe at 4 sites in Mexico.
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 7 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 7 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge G Jaspersen, MD-Urology ((5255) 55 64 53 70, jaspersen@prodigy.net.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score higher than or equal to 21 of the erectile dysfunction domain of the IIEF, or response to treatment (time frame: 42 weeks). The study lists 2 primary outcomes in all. 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 7 Nov 2007.