A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.

• 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:

• Completion of the Phase 3 protocol (NCT01665599)

Exclusion Criteria:

• Use of another investigational product

• Use of any medications that could be considered anabolic or interfere with androgen metabolism

• Use of estrogens, gonadotropin releasing hormone agonists/antagonists, antiandrogens, or human growth hormone

• Use of another testosterone product

• Chronic use of any drug of abuse