A Study to Test a Measure of Symptoms of Older Men With Low Testosterone On and Off Testosterone Replacement Treatment (P05815)

NCT ID: NCT00254553

Last Updated: 2015-12-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2007-01-31

Brief Summary

Hypogonadal males, particularly those whose condition manifested later in life, may experience common symptoms associated with their hypogonadism. Questionnaires developed to assess these symptoms need to be tested. The primary purpose of this study is to test or validate the Patient-Reported Symptom Measure, Androgen Deficiency Quality of Life Questionnaire and the Patient Global Impression Scale.

Conditions

Hypogonadism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

Testim 1% (testosterone gel)

Group Type: ACTIVE_COMPARATOR

Testim 1% (testosterone gel)

Intervention Type: DRUG

Testim\_ 100 mg: two tubes of 50 mg of Testim\_per day

Arm 2

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

two tubes of placebo per day

Interventions

Testim 1% (testosterone gel)

Testim\_ 100 mg: two tubes of 50 mg of Testim\_per day

Intervention Type: DRUG

Placebo

two tubes of placebo per day

Intervention Type: DRUG

Other Intervention Names

Testim

Eligibility Criteria

Inclusion Criteria

Men with late-onset hypogonadism who are either on testosterone treatment or naïve of treatment:

• have symptoms of androgen deficiency at screening (after wash-out if applicable) i.e. with a positive score on the Androgen Deficiency in the Aging Male (ADAM) Questionnaire (a "yes" answer to questions 1 or 7 or any three other questions).
• morning total T levels of <=3 ng/mL (<=300 ng/dL; <=10.4 nmol/l) on two separate days prior to randomization (after appropriate wash-out, if applicable).
• calculated free T <=0.074 ng/mL.
• at least 50 and at most 75 years of age.
• BMI of at least 18 kg/m^2 or at most 32 kg/m^2

• morning total T levels <=3 ng/mL (<=300 ng/dL; <=10.4 nmol/L).
• calculated free T <=0.074 ng/mL.
• at least 50 and at most 75 years of age.
• BMI of at least 18 kg/m^2 or at most 32 kg/m^2

Exclusion Criteria

• History or current diagnosis of prostate cancer or any clinically significant finding on prostate examination
• Severe obstructive symptoms of benign prostate hypertrophy
• Prostate specific antigen (PSA) levels greater than 4 ng/mL at screening
• History or current diagnosis of carcinoma of the breast
• Known chronic polycythemia and/or hematocrit greater than 50% at screening
• Treatment-naïve subjects with hyperprolactinemia at screening (serum prolactin level >=50 ng/mL)
• Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator
• clinically significant abnormal physical finding prior to randomization
• sensitive to trial medication or its components
• History or presence of hepatic or renal disorder considered as clinically relevant in the opinion of the investigator.

• Presence or previous diagnosis of androgen deficiency.
• Previous or present use of testosterone preparations
• Use of medication within the 12 weeks prior to the visit that may interfere with the objectives of the trial: hypothalamic/pituitary hormones and analogues (e.g., gonadotropins, ACTH, STH, Gn-RH agonists and antagonists, etc.); sex steroid
• Any other disease that in the opinion of the investigator might compromise or confound the subject's symptomatology (e.g., presence of clinically significant depression or other psychiatric disorders, unstable endocrine disorder, sleep apnea, cardiovascular and cerebrovascular diseases, etc.)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Countries

United States

Other Identifiers

P05815

Identifier Type: -

Identifier Source: secondary_id

169001

Identifier Type: -

Identifier Source: secondary_id

P05815

Identifier Type: -

Identifier Source: org_study_id