A Study to Test a Measure of Symptoms of Older Men With Low Testosterone On and Off Testosterone Replacement Treatment
Information source: Organon
Information obtained from ClinicalTrials.gov on May 08, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadism
Intervention: Testim 1% (testosterone gel) (Drug)
Phase: Phase 2
Status: No longer recruiting
Sponsored by: Organon Official(s) and/or principal investigator(s):
Ricardo Maamari, M.D., Study Director, Affiliation: Organon
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.
Clinical Details
Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two Period Cross Over Trial to Validate Patient-Reported Outcome Measures for Use in Men With Late Onset Hypogonadism
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment
Primary outcome: Patient-reported outcome measures will be taken at baseline (at wash-out) and after six weeks of treatment or placebo.
Eligibility
Minimum age: 50 Years.
Maximum age: 75 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
• Men with late-onset hypogonadism who are either on testosterone treatment or naïve of treatment.
- All subjects should 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).
- Subjects must have 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).
- Men should have a calculated free T <= 0. 074 ng/mL.
• Subjects should be at least 50 and at most 75 years of age.
• Subjects with a body mass index (BMI) of at least 18 kg/m2 or at most 32 kg/m2
Inclusion Criteria for Normogonadal Men:
• Subjects must have morning total T levels <=3 ng/mL (<=300 ng/dL; <=10. 4 nmol/L).
• Men should have a calculated free T <= 0. 074 ng/mL.
• Subjects should be at least 50 and at most 75 years of age.
• Subjects must have a body mass index (BMI) of at least 18 kg/m2 or at most 32 kg/m2.
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.
• Any clinically significant abnormal physical finding prior to randomization.
• Subjects 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.
Exclusion Criteria for Normogonadal Men:
• 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 steroids
• 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.)
Locations and Contacts
Organon Investigational Site, Birmingham, Alabama 90502, United States
Organon Investigational Site, Torrance, California 90502, United States
Organon Investigational Site, Vista, California 92084, United States
Organon Investigational Site, Aurora, Colorado 80012, United States
Organon Investigational Site, Waterbury, Connecticut 06708, United States
Organon Investigational Site, Gurnee, Illinois 60031, United States
Organon Investigational Site, Fort Wayne, Indiana 46825, United States
Organon Investigational Site, Boston, Massachusetts 02114, United States
Organon Investigational Site, Cleveland, Ohio 44122, United States
Organon Investigational Site, Oklahoma City, Oklahoma 73103, United States
Organon Investigational Site, San Antonio, Texas 78229, United States
Organon Investigational Site, Salt Lake City, Utah 98043, United States
Organon Investigational Site, Mountlake Terrace, Washington 98043, United States
Additional Information
Starting date:
July 2005
Ending date: December 2006
Last updated: January 17, 2007
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