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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 Concentration

Motile Total Sperm Count

Semen Volume

Secondary outcome:

Luteinizing Hormone (LH) Levels

Follicle 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

Page last updated: August 23, 2015

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