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

Efficacy and Safety of Fispemifene in the Treatment of Hypogonadal Men With Erectile Dysfunction Unresponsive to PDE5 Inhibitors: An 8-Week, Randomized, Double-Blind, Placebo-Controlled Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00415571

Enrollment

Registered

2006-12-25

Start date

2006-12-31

Completion date

2008-08-31

Last updated

2010-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction, Hypogonadism

Keywords

Hypogonadism, Erectile Dysfunction

Brief summary

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.

Interventions

DRUGFispemifene (once daily for 8 weeks)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026