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

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ClinicalTrials.gov Identifier: NCT02443090
Recruitment Status : Unknown
Verified November 2015 by NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.).
Recruitment status was:  Active, not recruiting
First Posted : May 13, 2015
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)

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

Condition or disease Intervention/treatment Phase
Secondary Hypogonadism Sexual Dysfunction Erectile Dysfunction Drug: fispemifene Other: Placebo Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2015
Actual Primary Completion Date : October 2015
Estimated Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: Fispemifene 450 mg
Fispemifene capsules will be taken orally each morning immediately after eating a meal
Drug: fispemifene
Placebo Comparator: Placebo
Placebo capsules will be taken orally each morning immediately after eating a meal
Other: Placebo



Primary Outcome Measures :
  1. Change in IIEF-EF (International Index of Erectile Function - erectile function domain) score [ Time Frame: 8 weeks ]
    Change in the IIEF-EF (International Index of Erectile Function - erectile function domain) score from Randomization to Week 8



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443090


Locations
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United States, Arkansas
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States, 72205
United States, California
San Diego Clinical Trials
San Diego, California, United States, 92120
Genesis Research LLC
San Diego, California, United States, 92123
United States, Florida
Meridien Research
Bradenton, Florida, United States, 34208
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
Well Pharma Medical Research
Miami, Florida, United States, 33144
United States, Louisiana
Regional Urology, LLC
Shreveport, Louisiana, United States, 71106
United States, New Jersey
Premier Urology Associates, LLC, dba AdvanceMed Research
Lawrence Township, New Jersey, United States, 08648
United States, New York
The Urological Institute of Northeastern New York
Albany, New York, United States, 12208
AccuMed Research Associates
Garden City, New York, United States, 11530
Bruce R. GIlbert, MD, PhD, PC
Great Neck, New York, United States, 11022
Manhattan Medical Research Practice PLLC
New York, New York, United States, 10016
United States, Tennessee
Volunteer Research
Knoxville, Tennessee, United States, 37920
Clinical Research Associates, Inc.
Nashville, Tennessee, United States, 37203
United States, Utah
Physicians' Research Options LLC
Draper, Utah, United States, 84020
United States, Virginia
Clinical Research Associates of Tidewater, Inc.
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
Investigators
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Study Director: Barbara Troupin, MD, MBA NexMed (U.S.A.), Inc.

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Responsible Party: NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
ClinicalTrials.gov Identifier: NCT02443090     History of Changes
Other Study ID Numbers: NM-F15-202
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015
Keywords provided by NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.):
secondary hypogonadism
sexual dysfunction
erectile dysfunction
Additional relevant MeSH terms:
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Erectile Dysfunction
Hypogonadism
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Gonadal Disorders
Endocrine System Diseases
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents