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Trial record 38 of 213 for:    "Hypogonadism" | "Androgens"

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

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ClinicalTrials.gov Identifier: NCT01786473
Recruitment Status : Unknown
Verified February 2013 by Laboratoires Besins International.
Recruitment status was:  Recruiting
First Posted : February 8, 2013
Last Update Posted : February 8, 2013
Sponsor:
Information provided by (Responsible Party):
Laboratoires Besins International

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.

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: Testogel 1% Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Double Blind, Randomized, Placebo Controlled Study of Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism
Study Start Date : December 2012
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Testogel 1% 5g QD Drug: Testogel 1%
Placebo Comparator: Placebo gel 5g QD Drug: Placebo



Primary Outcome Measures :
  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 [ Time Frame: 3 months ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01786473


Contacts
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Contact: Ellen Dhoore edhoore@besins-healthcare.com

Locations
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China
Peking University First Hospital Recruiting
Peking, China
Sponsors and Collaborators
Laboratoires Besins International
Investigators
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Principal Investigator: Jie Jin Peking University First Hospital

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Responsible Party: Laboratoires Besins International
ClinicalTrials.gov Identifier: NCT01786473     History of Changes
Other Study ID Numbers: 01BHR11
First Posted: February 8, 2013    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Hypogonadism
Androgens
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents