Safety and Efficacy Study of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men



Status:Active, not recruiting
Conditions:Erectile Dysfunction, Endocrine
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - 64
Updated:4/21/2016
Start Date:May 2015
End Date:April 2016

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An 8-Week Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men

To evaluate the safety and efficacy of fispemifene in men with secondary hypogonadism and
sexual side effects.

This phase 2 study is a double-blind, placebo controlled, parallel arm study with a 4 week
run-in and an 8-week treatment period. It will assess the safety and tolerability of
fispemifene, and the effects of treatment on the sexual side effects seen in this patient
population using PRO endpoints.

Inclusion Criteria:

- A confirmed diagnosis of secondary hypogonadism

- Mild to moderate erectile dysfunction

- Ability to read, understand and complete diaries and questionnaires

- Ability to safely make sexual attempts during the course of the study

Exclusion Criteria:

- Primary hypogonadism

- Hypogonadism as a result of surgery, trauma, tumors or radiation of the hypothalamus
or pituitary

- History or current diagnosis of breast cancer, prostate cancer and/or PSA level above
≥3.5 ng/mL

- Poorly controlled blood pressure, type 2 diabetes, thyroid disease; sleep apnea

- Elevated prolactin level

- Hemoglobin >17 g/dL or Hematocrit >50%

- Use of transdermal or oral testosterone within 4 weeks, intramuscular testosterone
therapy within 6 weeks, and testosterone pellets within 6 months prior to Screening
and at any time throughout the study

- Use of another SERM or past participation in a trial with Fispemifene

- Use of medications known to alter the HPG axis

- Clinically significant findings on physical exam, screening labs, or other findings
which would prevent safe participation in the study

- Participation in another clinical study in the last 30 days
We found this trial at
16
sites
Lawrence Township, New Jersey 08648
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Lawrence Township, NJ
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400 Gresham Dr
Norfolk, Virginia 23507
757-627-7446
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Norfolk, VA
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6719 Alvarado Road
San Diego, California 92120
619-287-6000
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San Diego, CA
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Albany, NY
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Bradenton, Florida
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Bradenton, FL
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801 Monterey Street
Coral Gables, Florida 33134
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Coral Gables, FL
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Draper, Utah 84020
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Draper, UT
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Garden City, New York 11530
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Garden City, NY
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Great Neck, New York 11022
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Great Neck, NY
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Knoxville, Tennessee 37920
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Knoxville, TN
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Little Rock, Arkansas 72205
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Little Rock, AR
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Miami, Florida 33143
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Miami, FL
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Nashville, Tennessee 37203
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Nashville, TN
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New York, New York 10016
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New York, NY
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San Diego, California 92123
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San Diego, CA
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Shreveport, Louisiana 71106
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Shreveport, LA
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