A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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