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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: QuatRx Pharmaceuticals Company
• Collaborator: Hormos Medical
• Treatments: Tamoxifen

Criteria

Inclusion Criteria:

• Total testosterone level <240 ng/dL

• Serum LH and FSH levels within normal limits

Exclusion Criteria:

• 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