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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00290134
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : March 3, 2008
Hormos Medical
Information provided by:
QuatRx Pharmaceuticals Company

Brief Summary:
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 or disease Intervention/treatment Phase
Hypogonadism Drug: Fispemifene once daily for 4 weeks Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : February 2006
Actual Study Completion Date : October 2007

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

Secondary Outcome Measures :
  1. Change in total testosterone levels from baseline to Weeks 2 and 6
  2. Change in free testosterone, calculated free testosterone, and DHT from baseline to Weeks 2, 4, and 6
  3. Change in SHBG, E2, LH, FSH and inhibin B from baseline to Weeks 2, 4, and 6

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00290134

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
Study Director: Janne Komi, MD, PhD Hormos Medical

Publications: Identifier: NCT00290134     History of Changes
Other Study ID Numbers: 101-50204
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: March 3, 2008
Last Verified: February 2008

Keywords provided by QuatRx Pharmaceuticals Company:

Additional relevant MeSH terms:
Gonadal Disorders
Endocrine System Diseases
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents