A Preliminary Clinical Study to Evaluate Fispemifene in the Treatment of Hypogonadism - Full Text View

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

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:

Liverman CT and Blazer DG (eds.): Testosterone and aging: Clinical research directions (Institute of Medicine of the National Academies), The National Academic Press, Washington, D.C., 2004.

Harman SM, Metter EJ, Tobin JD, Pearson J, Blackman MR; Baltimore Longitudinal Study of Aging. Longitudinal effects of aging on serum total and free testosterone levels in healthy men. Baltimore Longitudinal Study of Aging. J Clin Endocrinol Metab. 2001 Feb;86(2):724-31.

Feldman HA, Longcope C, Derby CA, Johannes CB, Araujo AB, Coviello AD, Bremner WJ, McKinlay JB. Age trends in the level of serum testosterone and other hormones in middle-aged men: longitudinal results from the Massachusetts male aging study. J Clin Endocrinol Metab. 2002 Feb;87(2):589-98.

Nieschlag E, Swerdloff R, Behre HM, Gooren LJ, Kaufman JM, Legros JJ, Lunenfeld B, Morley JE, Schulman C, Wang C, Weidner W, Wu FC; International Society of Andrology (ISA); International Society for the Study of the Aging Male (ISSAM); European Association of Urology (EAU). Investigation, treatment and monitoring of late-onset hypogonadism in males. ISA, ISSAM, and EAU recommendations. Eur Urol. 2005 Jul;48(1):1-4. No abstract available.

Morales A, Lunenfeld B; International Society for the Study of the Aging Male. Investigation, treatment and monitoring of late-onset hypogonadism in males. Official recommendations of ISSAM. International Society for the Study of the Aging Male. Aging Male. 2002 Jun;5(2):74-86. No abstract available.

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
Tamoxifen
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on May 21, 2013