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

This study has been terminated.
(Recruitment issues)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00254553
First received: November 14, 2005
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Hypogonadism
Drug: Testim 1% (testosterone gel)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Patient -reported outcome measures [ Time Frame: Baseline and after six weeks of treatment or placebo ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: July 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Testim 1% (testosterone gel)
Drug: Testim 1% (testosterone gel)
Testim_ 100 mg: two tubes of 50 mg of Testim_per day
Other Name: Testim
Placebo Comparator: Arm 2
Placebo
Drug: Placebo
two tubes of placebo per day

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Inclusion Criteria for Normogonadal Men:

  • 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.

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 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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00254553     History of Changes
Other Study ID Numbers: P05815, P05815, 169001
Study First Received: November 14, 2005
Last Updated: September 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on October 19, 2014