A Preliminary Clinical Study to Evaluate Fispemifene in the Treatment of Hypogonadism

Completed · Phase 2

Conditions studied: Hypogonadism

In brief

The purpose of this study is to determine whether one or more fispemifene dose regimens are more effective than placebo in the treatment of hypogonadism in older men.

Key facts

Study ID

NCT00290134

Run by

QuatRx Pharmaceuticals Company

People needed

100

Starts

2006-02-01

Expected to finish

2007-10-01

Last updated by the study team

2008-03-03

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Total testosterone level <240 ng/dL
• Serum LH and FSH levels within normal limits

You may not qualify if…

• Elevated prolactin
• Evidence of Benign Prostatic Hypertrophy
• History of or current breast cancer, prostate cancer, abnormal DRE or elevated PSA or any other malignancy
• Clinically significant endocrine/metabolic or cardiovascular disease
• Significant polycythemia

Where it is running

• Clinical Research Site — Huntsville, Alabama, United States
• Clinical Research Site — Modesto, California, United States
• Clinical Research Site — Aurora, Colorado, United States
• Clinical Research Site — Waterbury, Connecticut, United States
• Clinical Research Site — New Port Richey, Florida, United States
• Clinical Research Site — Tallahassee, Florida, United States
• Clinical Research Site — Peoria, Illinois, United States
• Clinical Research Site — Greenbelt, Maryland, United States
• Clinical Research Site — Las Vegas, Nevada, United States
• Clinical Research Site — Garden City, New York, United States
• Clinical Research Site — Poughkeepsie, New York, United States
• Clinical Research Site — Williamsville, New York, United States
• Clinical Research Site — Bethany, Oklahoma, United States
• Clinical Research Site — Greer, South Carolina, United States
• Clinical Research Site — San Antonio, Texas, United States
• Clinical Research Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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