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

Phase 2

Completed

• Conditions: Hypogonadism

• Registration Number: NCT00290134
• Lead Sponsor: QuatRx Pharmaceuticals Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-09
• Study First Submitted QC: 2006-02-09
• Study First Posted: 2006-02-10
• Study Completion: 2007-10
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-29
• Last Update Posted: 2008-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in morning total testosterone levels from baseline to Week 4 (end of therapy)

Secondary Outcome Measures

Name	Time	Method
Change in total testosterone levels from baseline to Weeks 2 and 6
Change in free testosterone, calculated free testosterone, and DHT from baseline to Weeks 2, 4, and 6
Change in SHBG, E2, LH, FSH and inhibin B from baseline to Weeks 2, 4, and 6

Trial Locations

Locations (1)

Clinical Research Site; 🇺🇸 Seattle, Washington, United States