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

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01786473
• Other study ID #: 01BHR11
• Status: Recruiting
• Phase: Phase 3
• First received: February 6, 2013
• Last updated: February 6, 2013
• Start date: December 2012

Study information

• Verified date: February 2013
• Source: Laboratoires Besins International
• Contact: Ellen Dhoore
• Email: edhoore[@]besins-healthcare.com
• Is FDA regulated: No
• Health authority: China: SFDA
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 68 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Testogel 1%

• Placebo

Locations

Country	Name	City	State
China	Peking University First Hospital	Peking

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Besins International

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		3 months	No
Secondary	morning serum Total Testosterone (TT) concentration compared to placebo treatment		3 months	No
Secondary	morning serum Total Testosterone (TT) concentration compared to baseline values		3 months	No
Secondary	serum concentrations of TT, calculated free testosterone (cFT), DHT, E2, LH, and FSH, SHBG		3 months	Yes
Secondary	prostate assessments (PSA, urine flow rate, DRE, ultrasound B)		3 months	Yes
Secondary	skin integrity		3 months	Yes