To Evaluate Fertility in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
Information source: Repros Therapeutics Inc.
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility in Men; Secondary Hypogonadism
Intervention: enclomiphene citrate (Drug); topical testosterone gel (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Repros Therapeutics Inc. Official(s) and/or principal investigator(s):
Ronald Wiehle, PhD, Study Director, Affiliation: Repros Therapeutics Inc.
Overall contact:
Ronald Wiehle, PhD, Phone: 281-719-3400, Email: administrator@reprosrx.com
Summary
To determine if Androxal® can correct the central defect in men who have AIHH that blocks
their ability to produce the hormones (LH and FSH) which stimulate testosterone production
and sertoli cell number, thereby restoring sperm count. Twelve subjects per group will be
randomized to daily treatments of Androxal® or topical testosterone Testim ® for six months.
These men must have been previously treated with exogenous 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: Treatment, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in semen volume, sperm count and sperm motility from baseline in men treated with Androxal®
Secondary outcome: Change in semen volume, sperm count and sperm motility in men treated with Androxal® versus men treated with Testim®
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 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
Ronald Wiehle, PhD, Phone: 281-719-3400, Email: administrator@reprosrx.com
University Urology Associates, New York, New York 10016, United States; Recruiting
Betsy Moclair, Phone: 212-686-9015, Email: bmoclair@universityurology.com
Jed Kaminetsky, MD, Principal Investigator
MAZE Labs, Purchase, New York 10577, United States; Recruiting
Tammy Facciolo, Phone: 914-997-4100, Email: tammy@mazelabs.com
Michael Werner, MD, Principal Investigator
Additional Information
Starting date: June 2008
Ending date: September 2009
Last updated: January 8, 2009
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