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

NCT00254553 | Terminated Phase 2

• 2 other identifiers: P05815169001
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Patient -reported outcome measures

  Baseline and after six weeks of treatment or placebo

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Testim 1% (testosterone gel)

Drug: Testim 1% (testosterone gel)

Arm 2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Testim 1% (testosterone gel) DRUG

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

Also known as: Testim

Arm 1

Placebo DRUG

two tubes of placebo per day

Arm 2

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2005
• First Posted: November 16, 2005
• Study Start: July 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: December 14, 2015

Record last verified: 2015-12