A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel

Ferring

Status and phase: Completed; Phase 3

Conditions: Adult Male Hypogonadism

Treatments: Drug: Testosterone Gel (FE 999093)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01703741

000077

Details and patient eligibility

About

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.

Enrollment: 145 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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145 participants in 1 patient group

Testosterone gel (FE 999093)

Experimental group

Description:

Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.

Treatment:

Drug: Testosterone Gel (FE 999093)