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

Hypogonadism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00290134
• Other study ID #: 101-50204
• Status: Completed
• Phase: Phase 2
• First received: February 9, 2006
• Last updated: February 29, 2008
• Start date: February 2006
• Est. completion date: October 2007

Study information

• Verified date: February 2008
• Source: QuatRx Pharmaceuticals Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Fispemifene once daily for 4 weeks

Locations

Country	Name	City	State
United States	Clinical Research Site	Aurora	Colorado
United States	Clinical Research Site	Bethany	Oklahoma
United States	Clinical Research Site	Garden City	New York
United States	Clinical Research Site	Greenbelt	Maryland
United States	Clinical Research Site	Greer	South Carolina
United States	Clinical Research Site	Huntsville	Alabama
United States	Clinical Research Site	Las Vegas	Nevada
United States	Clinical Research Site	Modesto	California
United States	Clinical Research Site	New Port Richey	Florida
United States	Clinical Research Site	Peoria	Illinois
United States	Clinical Research Site	Poughkeepsie	New York
United States	Clinical Research Site	San Antonio	Texas
United States	Clinical Research Site	Seattle	Washington
United States	Clinical Research Site	Tallahassee	Florida
United States	Clinical Research Site	Waterbury	Connecticut
United States	Clinical Research Site	Williamsville	New York

Sponsors (2)

Lead Sponsor	Collaborator
QuatRx Pharmaceuticals Company	Hormos Medical

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in morning total testosterone levels from baseline to Week 4 (end of therapy)
Secondary	Change in total testosterone levels from baseline to Weeks 2 and 6
Secondary	Change in free testosterone, calculated free testosterone, and DHT from baseline to Weeks 2, 4, and 6
Secondary	Change in SHBG, E2, LH, FSH and inhibin B from baseline to Weeks 2, 4, and 6