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Completed

NCT Number: NCT00290134

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

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.

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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Research Site, Huntsville, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fispemifene once daily for 4 weeks

Drug

Primary outcomes

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

Secondary outcomes

  1. Change in total testosterone levels from baseline to Weeks 2 and 6

  2. Change in free testosterone, calculated free testosterone, and DHT from baseline to Weeks 2, 4, and 6

  3. Change in SHBG, E2, LH, FSH and inhibin B from baseline to Weeks 2, 4, and 6

Sponsors and collaborators

Lead sponsor

QuatRx Pharmaceuticals Company

Industry

Collaborators

  • Hormos Medical

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Feb 10, 2006
Registry last updated
Mar 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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