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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Secondary Hypogonadism, Sexual Dysfunction, Erectile Dysfunction

In brief

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

Key facts

Study ID

NCT02443090

Run by

NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)

People needed

160

Starts

2015-05-01

Expected to finish

2016-04-01

Last updated by the study team

2015-11-13

Who can join

Age: 18 and older, up to 64. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
• San Diego Clinical Trials — San Diego, California, United States
• Genesis Research LLC — San Diego, California, United States
• Meridien Research — Bradenton, Florida, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Well Pharma Medical Research — Miami, Florida, United States
• Regional Urology, LLC — Shreveport, Louisiana, United States
• Premier Urology Associates, LLC, dba AdvanceMed Research — Lawrence, New Jersey, United States
• The Urological Institute of Northeastern New York — Albany, New York, United States
• AccuMed Research Associates — Garden City, New York, United States
• Bruce R. GIlbert, MD, PhD, PC — Great Neck, New York, United States
• Manhattan Medical Research Practice PLLC — New York, New York, United States
• Volunteer Research — Knoxville, Tennessee, United States
• Clinical Research Associates, Inc. — Nashville, Tennessee, United States
• Physicians' Research Options LLC — Draper, Utah, United States
• Clinical Research Associates of Tidewater, Inc. — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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