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

This study has been completed.
Hormos Medical
Information provided by:
QuatRx Pharmaceuticals Company Identifier:
First received: December 21, 2006
Last updated: February 2, 2010
Last verified: February 2010

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.

Condition Intervention Phase
Erectile Dysfunction
Drug: Fispemifene (once daily for 8 weeks)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by QuatRx Pharmaceuticals Company:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 72
Study Start Date: December 2006
Study Completion Date: August 2008

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00415571

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Sponsors and Collaborators
QuatRx Pharmaceuticals Company
Hormos Medical
  More Information


Responsible Party: Janice Margulies/ Development Scientist, QUATRx Identifier: NCT00415571     History of Changes
Other Study ID Numbers: 101-50608
Study First Received: December 21, 2006
Last Updated: February 2, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by QuatRx Pharmaceuticals Company:
Erectile Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Endocrine System Diseases
Genital Diseases, Male
Gonadal Disorders
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Phosphodiesterase 5 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors processed this record on November 19, 2014