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

Primary Purpose

Hypogonadism

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Testogel 1%
Placebo
Sponsored by
Laboratoires Besins International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Testogel 1% 5g QD

Placebo gel 5g QD

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2013
Last Updated
February 6, 2013
Sponsor
Laboratoires Besins International
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1. Study Identification

Unique Protocol Identification Number
NCT01786473
Brief Title
Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism
Official Title
A Multi-center, Double Blind, Randomized, Placebo Controlled Study of Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Besins International

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Testogel 1% 5g QD
Arm Type
Experimental
Arm Title
Placebo gel 5g QD
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Testogel 1%
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
morning serum Total Testosterone (TT) concentration compared to placebo treatment
Time Frame
3 months
Title
morning serum Total Testosterone (TT) concentration compared to baseline values
Time Frame
3 months
Title
serum concentrations of TT, calculated free testosterone (cFT), DHT, E2, LH, and FSH, SHBG
Time Frame
3 months
Title
prostate assessments (PSA, urine flow rate, DRE, ultrasound B)
Time Frame
3 months
Title
skin integrity
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen Dhoore
Email
edhoore@besins-healthcare.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Jin
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Peking
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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