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

QuatRx Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hypogonadism

Treatments: Drug: Fispemifene once daily for 4 weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00290134

101-50204

Details and patient eligibility

About

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.

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind