To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone

Repros Therapeutics

Status and phase: Completed; Phase 2

Conditions: Secondary Hypogonadism

Treatments: Drug: 25 mg Androxal; Drug: Testim 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00706719

ZA-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: Male

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy adult males between 21 and 60 years of age who have been diagnosed with AIHH.
• Subjects must have been treated with a topical testosterone replacement therapy (typically AndroGel® or Testim®) for at least 6 months at enrollment and for not more than 2 years.

Exclusion criteria

• A history of idiopathic infertility due to primary hypogonadism, testicular failure, Kallmann's syndrome or any other infertility condition.
• Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile other than AIHH.
• Men with a history of, known, or suspected prostate disease not ruled out by a prostate biopsy, or a prostate specific antigen (PSA)>3.6 or clinical suspicion of current prostate disease.
• Men with a hematocrit in excess of 50 % or hemoglobin >17 g/dl

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 3 patient groups

25 mg Androxal no wash out

Experimental group

Description:

1 capsule daily for 6 months of 25 mg of Androxal in men without a 3 month wash out period

Treatment:

Drug: 25 mg Androxal

Testim 1% (topical testosterone)

Active Comparator group

Description:

Testim 1% Gel applied topically for 6 months

Treatment:

Drug: Testim 1%

25 mg Androxal wash out

Experimental group

Description:

1 x 25 mg Androxal capsule daily for 6 months in men with a previous 3 month washout period of topical testosterone

Treatment:

Drug: 25 mg Androxal