Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism (Low Testosterone), That Wish to Maintain Their Reproductive Status
| Status: | Archived |
|---|---|
| Conditions: | Women's Studies, Endocrine |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | January 2011 |
| End Date: | January 2012 |
A Randomized, Double Blind, Placebo and Active Controlled, Parallel, Multi-Center Phase IIb Study to Evaluate Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism With Confirmed Morning Testosterone Levels <250 ng/dL That Wish to Preserve Their Reproductive Status and Are Not Currently Being Treated With Topical Testosterone
The Purpose of the study is to determine the effects of Androxal on morning testosterone and
reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less
than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The
effects of Testim versus placebo on reproductive status will also be examined. Study
subjects must not be currently using a topical testosterone.
This study is a phase IIb, 4 arm study with three month active dosing period. Three of the
four treatment groups will be randomized to either Androxal or placebo in a double-blind
fashion, and the fourth treatment group will receive open-label Testim. The doses of
Androxal in the blinded portion of the study will be 12.5 mg and 25 mg, in capsule form.
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