A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 10/28/2017 |
| Start Date: | July 2014 |
| End Date: | June 2015 |
A Phase 3, Open-Label, Non-Randomized, Clinical Trial to Evaluate the Efficacy and Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males
This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and
safety of FE 999303 (Testosterone gel) in adult hypogonadal males.
safety of FE 999303 (Testosterone gel) in adult hypogonadal males.
Inclusion Criteria:
- Males between 18-75 years of age
- Two fasting serum testosterone levels <300 ng/dL
Exclusion Criteria:
- Previous use of the study drug
- History of prostate or breast cancer
- Prostate-Specific Antigen (PSA) ≥3 ng/mL
- Subject is sexually active and not willing to use adequate contraception
We found this trial at
22
sites
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