Conditions: Testicular Hypogonadism
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

Brief summary:
This is an open-label study of a single and repeated application of three dose levels of topical testosterone in hypogonadal males with morning serum testosterone concentrations \< 297 ng/dL.

Detailed description:

Arms:
arm 1: Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the inner thigh followed by a seven day washout period. arm 2: Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the abdomen followed by a seven day washout period. arm 3: Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the shoulder/upper arm. arm 4: Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke) applied once daily for 10 consecutive days to the shoulder/upper arm. arm 5: Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes) applied once daily for 10 consecutive days to the shoulder/upper arm. arm 6: Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes) applied once daily for 10 consecutive days to the shoulder/upper arm.

Interventions: intervention 1: Testosterone gel (FE 99903)
Intervention descriptions: intervention 1: None

Protocol document: