NCT00555087

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

November 7, 2007

Status Verified

November 1, 2007

First QC Date

November 5, 2007

Last Update Submit

November 5, 2007

Conditions

Erectile DysfunctionHypogonadotrophic Males

Keywords

Erectile dysfunctionHypogonadotrophic males

Outcome Measures

Primary Outcomes (2)

  • Score higher than or equal to 21 of the erectile dysfunction domain of the IIEF, or response to treatment

    42 weeks

  • and/or an affirmative response to the GAQ will be considered for the analysis

    10 months

Study Arms (1)

A= Nebido

EXPERIMENTAL

It is and intervention study with 1 arm

Drug: Testosterone Undecanoate and/or PDE-5

Interventions

Testosterone Undecanoate and/or PDE-5DRUG

Testosterone Undecanoate 1000 mg IM injection; PDF5 tab, 20 mg

Also known as: Nebido, Levitra
A= Nebido

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Santa Fe

Mexico City, D.F., 06700, Mexico

NOT YET RECRUITING

Hospital General de Occidente

Guadalajara, Jalisco, 045040, Mexico

RECRUITING

Hospital General de Occidente

Guadalajara, Jalisco, 44690, Mexico

NOT YET RECRUITING

Hospital Universitario de Nuevo León

Monterrey, Nuevo León, 64460, Mexico

NOT YET RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

testosterone undecanoateVardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Jorge Jaspersen, MD

    H Santa Fe

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge G Jaspersen, MD-Urology

CONTACT

(5255) 55 64 53 70jaspersen@prodigy.net.mx

Lauro G Gomez, MD

CONTACT

(5255) 818 2204 444laurogomez@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 5, 2007

First Posted

November 7, 2007

Study Start

May 1, 2007

Study Completion

January 1, 2008

Last Updated

November 7, 2007

Record last verified: 2007-11

Locations

ME(4)