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

This study has been completed.
Sponsor:
Collaborator:
Hormos Medical
Information provided by:
QuatRx Pharmaceuticals Company
ClinicalTrials.gov Identifier:
NCT00290134
First received: February 9, 2006
Last updated: February 29, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Hypogonadism
Drug: Fispemifene once daily for 4 weeks
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Preliminary Efficacy and Safety of Fispemifene in the Treatment of Hypogonadism: A 4 Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Daily Oral Doses of 100, 200, and 300 mg Fispemifene and Placebo

Further study details as provided by QuatRx Pharmaceuticals Company:

Primary Outcome Measures:
  • Change in morning total testosterone levels from baseline to Week 4 (end of therapy)

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 100
Study Start Date: February 2006
Study Completion Date: October 2007
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT00290134

Locations
United States, Alabama
Clinical Research Site
Huntsville, Alabama, United States, 35801
United States, California
Clinical Research Site
Modesto, California, United States, 95350
United States, Colorado
Clinical Research Site
Aurora, Colorado, United States, 80012
United States, Connecticut
Clinical Research Site
Waterbury, Connecticut, United States, 06708
United States, Florida
Clinical Research Site
New Port Richey, Florida, United States, 34652
Clinical Research Site
Tallahassee, Florida, United States, 32308
United States, Illinois
Clinical Research Site
Peoria, Illinois, United States, 61614
United States, Maryland
Clinical Research Site
Greenbelt, Maryland, United States, 20770
United States, Nevada
Clinical Research Site
Las Vegas, Nevada, United States, 89109
United States, New York
Clinical Research Site
Garden City, New York, United States, 11530
Clinical Research Site
Poughkeepsie, New York, United States, 12601
Clinical Research Site
Williamsville, New York, United States, 14221
United States, Oklahoma
Clinical Research Site
Bethany, Oklahoma, United States, 73008
United States, South Carolina
Clinical Research Site
Greer, South Carolina, United States, 29650
United States, Texas
Clinical Research Site
San Antonio, Texas, United States, 78229
United States, Washington
Clinical Research Site
Seattle, Washington, United States, 98166
Sponsors and Collaborators
QuatRx Pharmaceuticals Company
Hormos Medical
Investigators
Study Director: Janne Komi, MD, PhD Hormos Medical
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00290134     History of Changes
Other Study ID Numbers: 101-50204
Study First Received: February 9, 2006
Last Updated: February 29, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by QuatRx Pharmaceuticals Company:
Hypogonadism
Testosterone

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014