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

November 11, 2015 updated by: NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

160

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
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Baptist Health Center For Clinical Research
    • California
      • San Diego, California, United States, 92120
        • San Diego Clinical Trials
      • San Diego, California, United States, 92123
        • Genesis Research LLC
    • Florida
      • Bradenton, Florida, United States, 34208
        • Meridien Research
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
      • Miami, Florida, United States, 33144
        • Well Pharma Medical Research
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology, LLC
    • New Jersey
      • Lawrence Township, New Jersey, United States, 08648
        • Premier Urology Associates, LLC, dba AdvanceMed Research
    • New York
      • Albany, New York, United States, 12208
        • The Urological Institute of Northeastern New York
      • Garden City, New York, United States, 11530
        • AccuMed Research Associates
      • Great Neck, New York, United States, 11022
        • Bruce R. Gilbert, MD, PhD, PC
      • New York, New York, United States, 10016
        • Manhattan Medical Research Practice PLLC
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Volunteer Research
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates, Inc.
    • Utah
      • Draper, Utah, United States, 84020
        • Physicians' Research Options LLC
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Clinical Research Associates of Tidewater, Inc.

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

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks

Collaborators and Investigators

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

Sponsor

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

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

May 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Estimate)

November 13, 2015

Last Update Submitted That Met QC Criteria

November 11, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NM-F15-202

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.

Clinical Trials on Sexual Dysfunction

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe