Clinical trial NCT00290134: A Preliminary Clinical Study to Evaluate Fispemifene in the Treatment of Hypogonadism
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypogonadism
Keywords: Hypogonadism
Testosterone
Lead sponsor: QuatRx Pharmaceuticals Company
Sponsor class: INDUSTRY
Collaborators: name: Hormos Medical
First posted: 2006-02-10
Enrollment: 100
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in morning total testosterone levels from baseline to Week 4 (end of therapy)
Secondary outcomes:
measure: Change in total testosterone levels from baseline to Weeks 2 and 6
measure: Change in free testosterone, calculated free testosterone, and DHT from baseline to Weeks 2, 4, and 6
measure: Change in SHBG, E2, LH, FSH and inhibin B from baseline to Weeks 2, 4, and 6
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clinical Research Site
state: Alabama
city: Modesto
country: United States
facility: Clinical Research Site
state: California
city: Aurora
country: United States
facility: Clinical Research Site
state: Colorado
city: Waterbury
country: United States
facility: Clinical Research Site
state: Connecticut
city: New Port Richey
country: United States
facility: Clinical Research Site
state: Florida
city: Tallahassee
country: United States
facility: Clinical Research Site
state: Florida
city: Peoria
country: United States
facility: Clinical Research Site
state: Illinois
city: Greenbelt
country: United States
facility: Clinical Research Site
state: Maryland
city: Las Vegas
country: United States
facility: Clinical Research Site
state: Nevada
city: Garden City
country: United States
facility: Clinical Research Site
state: New York
city: Poughkeepsie
country: United States
facility: Clinical Research Site
state: New York
city: Williamsville
country: United States
facility: Clinical Research Site
state: New York
city: Bethany
country: United States
facility: Clinical Research Site
state: Oklahoma
city: Greer
country: United States
facility: Clinical Research Site
state: South Carolina
city: San Antonio
country: United States
facility: Clinical Research Site
state: Texas
city: Seattle
country: United States
facility: Clinical Research Site
state: Washington
Study officials:
affiliation: Hormos Medical
name: Janne Komi, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Institute of Medicine (US) Committee on Assessing the Need for Clinical Trials of Testosterone Replacement Therapy; Liverman CT, Blazer DG, editors. Testosterone and Aging: Clinical Research Directions. Washington (DC): National Academies Press (US); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK216173/
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. doi: 10.1210/jcem.86.2.7219.
citation: 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. doi: 10.1210/jcem.87.2.8201.
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. doi: 10.1016/j.eururo.2005.04.027. No abstract available.
citation: 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.