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:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00254553
First received: November 14, 2005
Last updated: October 2, 2009
Last verified: October 2009
Tracking Information | |
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First Received Date ICMJE | November 14, 2005 |
Last Updated Date | October 2, 2009 |
Start Date ICMJE | July 2005 |
Primary Completion Date | January 2007 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
Patient -reported outcome measures [ Time Frame: Baseline and after six weeks of treatment or placebo ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE |
Pateint reported outcome measures will be taken at baseline (at wash out) and after six weeks of treatment or placebo. |
Change History | Complete list of historical versions of study NCT00254553 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE | |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | A Study to Test a Measure of Symptoms of Older Men With Low Testosterone On and Off Testosterone Replacement Treatment (TERMINATED)(P05815) |
Official Title ICMJE | 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 |
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. |
Detailed Description | |
Study Type ICMJE | Interventional |
Study Phase | Phase 2 |
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
Condition ICMJE | Hypogonadism |
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Terminated |
Enrollment ICMJE | 150 |
Completion Date | January 2007 |
Primary Completion Date | January 2007 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria: Men with late-onset hypogonadism who are either on testosterone treatment or naïve of treatment:
Inclusion Criteria for Normogonadal Men:
Exclusion Criteria:
Exclusion Criteria for Normogonadal Men:
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Gender | Male |
Ages | 50 Years to 75 Years |
Accepts Healthy Volunteers | Yes |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | |
Administrative Information | |
NCT Number ICMJE | NCT00254553 |
Other Study ID Numbers ICMJE | 169001, P05815 |
Has Data Monitoring Committee | No |
Responsible Party | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
Study Sponsor ICMJE | Schering-Plough |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Schering-Plough |
Verification Date | October 2009 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |