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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00254553 |
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 II |
| 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 |
| 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 |
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:
Contacts and Locations
More Information
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00254553 History of Changes |
| Other Study ID Numbers: | 169001, P05815 |
| Study First Received: | November 14, 2005 |
| Last Updated: | October 2, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
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 |