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

Repros Therapeutics Inc.17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Secondary Hypogonadism

Interventions

25 mg AndroxalDRUG

25 mg Androxal capsules, 1 capsule daily for 6 months

Testim 1%DRUG

Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months

Eligibility

Sex: MALEMin age: 21 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

University Urology Associates

New York, New York, United States

MAZE Labs

Purchase, New York, United States