Efficacy and Safety Evaluating Fispemifene in the Treatment of Hypogonadal Men With Erectile Dysfunction Unresponsive to PDE5 Inhibitors

QuatRx Pharmaceuticals Company72 enrolled

Overview

The objective of the study is to assess and compare the preliminary efficacy, safety and tolerability of fispemifene 300 mg and placebo given once daily for 8 weeks in the treatment of hypogonadal men with erectile dysfunction (ED) unresponsive to PDE5 inhibitors.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypogonadism Erectile Dysfunction

Interventions

Fispemifene (once daily for 8 weeks)DRUG

Eligibility

Sex: MALEMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hypogonadal (morning total testosterone levels ≤400 ng/dl) men age ≥20 with ED who are unresponsive to PDE5 inhibitors, as demonstrated by International Index of Erectile Function (IIEF) results for 28-day lead in period.

Locations (14)

Radiant Research

Birmingham, Alabama, United States

Genova Clinical Research

Tucson, Arizona, United States

HealthStar Research

Hot Springs, Arkansas, United States

Outcomes

Primary Outcomes

Change in the IIEF erectile function domain score from baseline to Week 8/Early Termination;

Change in total testosterone levels from baseline to Week 8/Early Termination

Data from ClinicalTrials.gov

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