Trials / Terminated
TerminatedNCT00254553
A Study to Test a Measure of Symptoms of Older Men With Low Testosterone On and Off Testosterone Replacement Treatment (P05815)
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- Male
- Age
- 50 Years – 75 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Testim 1% (testosterone gel) | Testim\_ 100 mg: two tubes of 50 mg of Testim\_per day |
| DRUG | Placebo | two tubes of placebo per day |
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2007-01-01
- Completion
- 2007-01-01
- First posted
- 2005-11-16
- Last updated
- 2015-12-14
Source: ClinicalTrials.gov record NCT00254553. Inclusion in this directory is not an endorsement.