Status:
COMPLETED
A Preliminary Clinical Study to Evaluate Fispemifene in the Treatment of Hypogonadism
Lead Sponsor:
QuatRx Pharmaceuticals Company
Collaborating Sponsors:
Hormos Medical
Conditions:
Hypogonadism
Eligibility:
MALE
40+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Total testosterone level \<240 ng/dL
- Serum LH and FSH levels within normal limits
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
October 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00290134
Start Date
February 1 2006
End Date
October 1 2007
Last Update
March 3 2008
Active Locations (16)
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1
Clinical Research Site
Huntsville, Alabama, United States, 35801
2
Clinical Research Site
Modesto, California, United States, 95350
3
Clinical Research Site
Aurora, Colorado, United States, 80012
4
Clinical Research Site
Waterbury, Connecticut, United States, 06708