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

Condition(s) targeted: Hypogonadism

Intervention: Fispemifene once daily for 4 weeks (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: QuatRx Pharmaceuticals Company

Official(s) and/or principal investigator(s):
Janne Komi, MD, PhD, Study Director, Affiliation: Hormos Medical

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.

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

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

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Male.

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

Clinical Research Site, Huntsville, Alabama 35801, United States

Clinical Research Site, Modesto, California 95350, United States

Clinical Research Site, Aurora, Colorado 80012, United States

Clinical Research Site, Waterbury, Connecticut 06708, United States

Clinical Research Site, Tallahassee, Florida 32308, United States

Clinical Research Site, New Port Richey, Florida 34652, United States

Clinical Research Site, Peoria, Illinois 61614, United States

Clinical Research Site, Greenbelt, Maryland 20770, United States

Clinical Research Site, Las Vegas, Nevada 89109, United States

Clinical Research Site, Williamsville, New York 14221, United States

Clinical Research Site, Poughkeepsie, New York 12601, United States

Clinical Research Site, Garden City, New York 11530, United States

Clinical Research Site, Bethany, Oklahoma 73008, United States

Clinical Research Site, Greer, South Carolina 29650, United States

Clinical Research Site, San Antonio, Texas 78229, United States

Clinical Research Site, Seattle, Washington 98166, United States

Related 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.

Starting date: February 2006
Ending date: October 2006
Last updated: September 6, 2006