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

QuatRx Pharmaceuticals Company100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Hypogonadism

Interventions

Fispemifene once daily for 4 weeksDRUG

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (16)

Clinical Research Site

Huntsville, Alabama, United States

Clinical Research Site

Modesto, California, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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