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

Primary Purpose

Hypogonadism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fispemifene once daily for 4 weeks
Sponsored by
QuatRx Pharmaceuticals Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring Hypogonadism, Testosterone

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site

Outcomes

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

Full Information

First Posted
February 9, 2006
Last Updated
February 29, 2008
Sponsor
QuatRx Pharmaceuticals Company
Collaborators
Hormos Medical
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1. Study Identification

Unique Protocol Identification Number
NCT00290134
Brief Title
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

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
QuatRx Pharmaceuticals Company
Collaborators
Hormos Medical

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
Hypogonadism, Testosterone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fispemifene once daily for 4 weeks
Primary Outcome Measure Information:
Title
Change in morning total testosterone levels from baseline to Week 4 (end of therapy)
Secondary Outcome Measure Information:
Title
Change in total testosterone levels from baseline to Weeks 2 and 6
Title
Change in free testosterone, calculated free testosterone, and DHT from baseline to Weeks 2, 4, and 6
Title
Change in SHBG, E2, LH, FSH and inhibin B from baseline to Weeks 2, 4, and 6

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janne Komi, MD, PhD
Organizational Affiliation
Hormos Medical
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Clinical Research Site
City
Modesto
State/Province
California
ZIP/Postal Code
95350
Country
United States
Facility Name
Clinical Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Clinical Research Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Clinical Research Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Clinical Research Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Clinical Research Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Clinical Research Site
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
Clinical Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Clinical Research Site
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Clinical Research Site
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Clinical Research Site
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Clinical Research Site
City
Bethany
State/Province
Oklahoma
ZIP/Postal Code
73008
Country
United States
Facility Name
Clinical Research Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Clinical Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinical Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98166
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25009850
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/
Results Reference
background
PubMed Identifier
11158037
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.
Results Reference
background
PubMed Identifier
11836290
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.
Results Reference
background
PubMed Identifier
15951102
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.
Results Reference
background
PubMed Identifier
12198738
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.
Results Reference
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A Preliminary Clinical Study to Evaluate Fispemifene in the Treatment of Hypogonadism

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