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

NCT01786473 | Unknown Phase 3

• 1 other identifier: 01BHR11
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadism

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• morning serum Total Testosterone (TT) concentration compared to placebo treatment

  3 months

• morning serum Total Testosterone (TT) concentration compared to baseline values

  3 months

• serum concentrations of TT, calculated free testosterone (cFT), DHT, E2, LH, and FSH, SHBG

  3 months

• prostate assessments (PSA, urine flow rate, DRE, ultrasound B)

  3 months

• skin integrity

  3 months

Study Arms (2)

Testogel 1% 5g QD

EXPERIMENTAL

Drug: Testogel 1%

Placebo gel 5g QD

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Testogel 1% DRUG

Testogel 1% 5g QD

Placebo DRUG

Placebo gel 5g QD

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratoires Besins International: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Jie Jin

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen Dhoore

CONTACT

edhoore@besins-healthcare.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 8, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Last Updated: February 8, 2013

Record last verified: 2013-02

Locations

CN (1)