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

February 29, 2008 updated by: QuatRx Pharmaceuticals Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Clinical Research Site
    • California
      • Modesto, California, United States, 95350
        • Clinical Research Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Clinical Research Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Clinical Research Site
    • Florida
      • New Port Richey, Florida, United States, 34652
        • Clinical Research Site
      • Tallahassee, Florida, United States, 32308
        • Clinical Research Site
    • Illinois
      • Peoria, Illinois, United States, 61614
        • Clinical Research Site
    • Maryland
      • Greenbelt, Maryland, United States, 20770
        • Clinical Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Clinical Research Site
    • New York
      • Garden City, New York, United States, 11530
        • Clinical Research Site
      • Poughkeepsie, New York, United States, 12601
        • Clinical Research Site
      • Williamsville, New York, United States, 14221
        • Clinical Research Site
    • Oklahoma
      • Bethany, Oklahoma, United States, 73008
        • Clinical Research Site
    • South Carolina
      • Greer, South Carolina, United States, 29650
        • Clinical Research Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Clinical Research Site
    • Washington
      • Seattle, Washington, United States, 98166
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QuatRx Pharmaceuticals Company

Collaborators

Hormos Medical

Investigators

  • Study Director: Janne Komi, MD, PhD, Hormos Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 9, 2006

First Submitted That Met QC Criteria

February 9, 2006

First Posted (Estimate)

February 10, 2006

Study Record Updates

Last Update Posted (Estimate)

March 3, 2008

Last Update Submitted That Met QC Criteria

February 29, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101-50204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe