NCT00290134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

March 3, 2008

Status Verified

February 1, 2008

First QC Date

February 9, 2006

Last Update Submit

February 29, 2008

Conditions

Hypogonadism

Keywords

HypogonadismTestosterone

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • 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

Interventions

Fispemifene once daily for 4 weeksDRUG

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Total testosterone level \<240 ng/dL
  • Serum LH and FSH levels within normal limits

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Clinical Research Site

Huntsville, Alabama, 35801, United States

Location

Clinical Research Site

Modesto, California, 95350, United States

Location

Clinical Research Site

Aurora, Colorado, 80012, United States

Location

Clinical Research Site

Waterbury, Connecticut, 06708, United States

Location

Clinical Research Site

New Port Richey, Florida, 34652, United States

Location

Clinical Research Site

Tallahassee, Florida, 32308, United States

Location

Clinical Research Site

Peoria, Illinois, 61614, United States

Location

Clinical Research Site

Greenbelt, Maryland, 20770, United States

Location

Clinical Research Site

Las Vegas, Nevada, 89109, United States

Location

Clinical Research Site

Garden City, New York, 11530, United States

Location

Clinical Research Site

Poughkeepsie, New York, 12601, United States

Location

Clinical Research Site

Williamsville, New York, 14221, United States

Location

Clinical Research Site

Bethany, Oklahoma, 73008, United States

Location

Clinical Research Site

Greer, South Carolina, 29650, United States

Location

Clinical Research Site

San Antonio, Texas, 78229, United States

Location

Clinical Research Site

Seattle, Washington, 98166, United States

Location

Related Publications (5)

  • 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/

    PMID: 25009850BACKGROUND

  • 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.

    PMID: 11158037BACKGROUND

  • 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.

    PMID: 11836290BACKGROUND

  • 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.

    PMID: 15951102BACKGROUND

  • 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.

    PMID: 12198738BACKGROUND

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Officials

  • Janne Komi, MD, PhD

    Hormos Medical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 9, 2006

First Posted

February 10, 2006

Study Start

February 1, 2006

Study Completion

October 1, 2007

Last Updated

March 3, 2008

Record last verified: 2008-02

Locations

US(16)