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A Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral
Testosterone in Hypo gonadal Men. This is a multicenter, Phase 3,
randomized, open-label, parallel-group study evaluation the efficacy and
safety of oral meds. Subjects will undergo a screening period to
complete the pre-study examinations and to establish their hypogonadal
The main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with low testosterone and decreased sexual arousal, interest and drive and/or decreased energy. As well as to evaluate change from baseline to endpoint in the International Prostate Symptom Score (O-PSS), the SF-36v2TM Health Survey Version 2.0 (SF-36 quality-of-life questionnaire, and the Psychosexual Daily Questionnaire (PDQ) for the oral meds and Androgel treatment groups.
What is a clinical research study?
A clinical research study is a study in human participants to help answer specific health-related questions. Some research studies determine whether investigational treatments or new ways of using approved treatments are safe and effective.
What is the medication?
Oral testosterone undecanoate
Who is eligible for this research study?
If you have believe you have low testosterone or if your doctor has told you your testosterone level is low, you may qualify for a research study to treat low testosterone. Hypogonadal males ages 18-80 years of age (inclusive), with onset of hypogonadism diagnosed at age under 65. The study doctor is the only person who can determine whether you are eligible to participate in the study or not.
What can I gain from joining a clinical research study?
Participants in clinical research play an integral role in developing potentially better ways to treat various medical conditions. Additionally, throughout your participation in a clinical research study, you will receive study-related medical care and monitoring.
What questions should I ask if I am thinking about a clinical
If you want to take part in a clinical research study, you should inform the study doctor and his/her staff of your interest. If you qualify to participate, the study doctor and his/her staff will provide you with the informed Consent document, which will provide you with more information regarding the study. They will review all the information with you and give you the opportunity to ask question about anything you do not understand. Questions you should ask include; if the study medication is investigational? what treatments are available for your condition? how long does the study last? what benefits or side effects might you experience? what happens if I have side effects?
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Current Trials are Phase II, III and IV
Low Testosterone Clinical Research