Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism

February 6, 2013 updated by: Laboratoires Besins International

A Multi-center, Double Blind, Randomized, Placebo Controlled Study of Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism

The purpose of this study is to evaluate the safety and efficacy of Testogel® 50mg/5g gel administered once daily (QD, morning dosing) compared to placebo administered once daily (QD, morning dosing), for 3 months, in hypogonadal men with testosterone deficiency being confirmed by clinical features and biochemical tests. For men with hypogonadism, treatment aims to restore testosterone levels to normal physiological range.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Peking, China
        • Recruiting
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male ages 18-68 years diagnosed as having testosterone deficiency with clinical symptoms
  • A morning (8:00-10:00) serum Total Testosterone concentration of ≤ 300 ng/dL, confirmed by a second measurement of morning serum Total Testosterone concentration ≤ 300 ng/dL (samples to be taken 1 - 3 weeks apart)

Exclusion Criteria:

  • Abnormal prostate as evidenced by prostatic symptoms, prostatic masses or induration on rectal examination, or elevated levels of prostate specific antigen (PSA > 4ng/ml) or a maximum urine flow rate of less than 12 ml/sec(of a urine volume greater than 150ml) (and/or an International Prostate Symptom Score IPSS score >19)
  • Hematocrit > 50%
  • Major psychiatric illness
  • Unable to understand the protocol or to give informed consent
  • Use of paroxetine and clomipramine
  • Active alcoholism
  • History of drug abuse within the past five years;
  • Use of drugs that might interfere with the results of the study (e.g., antiandrogen, estrogens or P 450 enzyme inducers, barbiturates);
  • BMI < 18 or > 30 according to Chinese BMI references;
  • Generalized skin disease that may affect absorption of T (e.g., psoriasis) or a known skin intolerance to alcohol;
  • Prolactin > 40 mcg/L;
  • Untreated severe obstructive sleep apnea;.
  • Uncontrolled or poorly controlled heart failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Testogel 1% 5g QD
Drug: Testogel 1%
Placebo Comparator: Placebo gel 5g QD
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with morning serum Total Testosterone concentration within the physiological range (300 - 1000 ng/dL or 10.4 - 34.7 nmol/L) after 3 months of Testogel treatment compared to placebo-treatment
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
morning serum Total Testosterone (TT) concentration compared to placebo treatment
Time Frame: 3 months
3 months
morning serum Total Testosterone (TT) concentration compared to baseline values
Time Frame: 3 months
3 months
serum concentrations of TT, calculated free testosterone (cFT), DHT, E2, LH, and FSH, SHBG
Time Frame: 3 months
3 months
prostate assessments (PSA, urine flow rate, DRE, ultrasound B)
Time Frame: 3 months
3 months
skin integrity
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Besins International

Investigators

  • Principal Investigator: Jie Jin, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (Estimate)

February 8, 2013

Study Record Updates

Last Update Posted (Estimate)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 6, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01BHR11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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