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

B

Besins Healthcare

Status and phase

Unknown
Phase 3

Conditions

Hypogonadism

Treatments

Drug: Placebo
Drug: Testogel 1%

Study type

Interventional

Funder types

Industry

Identifiers

NCT01786473
01BHR11

Details and patient eligibility

About

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.

Enrollment

240 estimated patients

Sex

Male

Ages

18 to 68 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

240 participants in 2 patient groups, including a placebo group

Testogel 1% 5g QD
Experimental group
Treatment:
Drug: Testogel 1%
Placebo gel 5g QD
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Ellen Dhoore

Data sourced from clinicaltrials.gov

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