Clinical trial NCT00706719: To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
Official title: A Randomized, Open-Label, Fixed Dose, Active-Control, Multi-Center Phase IIB Study to Evaluate Fertility in Men With Secondary Hypogonadism, Comparing Androxal® to a Topical Testosterone in Men Previously Treated With Topical Testosterone.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Secondary Hypogonadism
Keywords: Adult Onset Idiopathic Hypothalamic Hypogonadism (AIHH)
Secondary hypogonadism
Semen volume
Sperm count
Sperm motility
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-27
Enrollment: 17
Sex: MALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sperm Concentration
timeFrame: Baseline, Month 3, Month 6, Follow-Up (Month 7)
measure: Motile Total Sperm Count
timeFrame: Baseline, Month 3, Month 6, Follow-Up (Month 7)
measure: Semen Volume
timeFrame: Baseline, Month 3, Month 6, Follow-Up (Month 7)
Secondary outcomes:
measure: Luteinizing Hormone (LH) Levels
timeFrame: Baseline, Month 3, Month 6, Follow-Up (Month 7)
measure: Follicle Stimulating Hormone (FSH) Levels
timeFrame: Baseline, Month 3, Month 6, Follow-Up (Month 7)
Other outcomes:
Locations:
city: New York
country: United States
facility: University Urology Associates
state: New York
city: Purchase
country: United States
facility: MAZE Labs
state: New York
Study officials:
affiliation: Repros Therapeutics Inc.
name: Ronald Wiehle, PhD
role: STUDY_DIRECTOR
References: