Conditions: Secondary Hypogonadism
Keywords: Adult Onset Idiopathic Hypothalamic Hypogonadism (AIHH) Secondary hypogonadism Semen volume Sperm count Sperm motility
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 17
Healthy volunteers: no

Brief summary:
The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone.

Detailed description:
The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone. A maximum of twelve subjects per group were randomized to daily treatments of Androxal® or topical testosterone (Testim®) for six months. The protocol was later amended to include a treatment group who received Androxal after a 3 month wash out period.

Arms:
arm 1: 1 capsule daily for 6 months of 25 mg of Androxal in men without a 3 month wash out period arm 2: Testim 1% Gel applied topically for 6 months arm 3: 1 x 25 mg Androxal capsule daily for 6 months in men with a previous 3 month washout period of topical testosterone

Interventions: intervention 1: 25 mg Androxal intervention 2: Testim 1%
Intervention descriptions: intervention 1: 25 mg Androxal capsules, 1 capsule daily for 6 months intervention 2: Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months

Protocol document: