To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
Information source: Repros Therapeutics Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Secondary Hypogonadism
Intervention: 25 mg Androxal (Drug); Testim 1% (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Repros Therapeutics Inc. Official(s) and/or principal investigator(s): Ronald Wiehle, PhD, Study Director, Affiliation: Repros Therapeutics Inc.
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Sperm ConcentrationMotile Total Sperm Count Semen Volume
Secondary outcome: Luteinizing Hormone (LH) LevelsFollicle Stimulating Hormone (FSH) Levels
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
Minimum age: 21 Years.
Maximum age: 60 Years.
Gender(s): Male.
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
Locations and Contacts
University Urology Associates, New York, New York 10016, United States
MAZE Labs, Purchase, New York 10577, United States
Additional Information
Starting date: June 2008
Last updated: July 22, 2015
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