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

Ferring

Status and phase: Completed; Phase 3

Conditions: Adult Male Hypogonadism

Treatments: Drug: Testosterone gel (FE 999303)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02149264

000127

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

Testosterone gel (FE 999303)

Experimental group

Description:

Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.

Treatment:

Drug: Testosterone gel (FE 999303)