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

Primary Purpose

Secondary Hypogonadism, Sexual Dysfunction, Erectile Dysfunction

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fispemifene
Placebo
Sponsored by
NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hypogonadism focused on measuring secondary hypogonadism, sexual dysfunction, erectile dysfunction

Eligibility Criteria

18 Years - 64 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Baptist Health Center for Clinical Research
  • San Diego Clinical Trials
  • Genesis Research LLC
  • Meridien Research
  • Clinical Research of South Florida
  • Well Pharma Medical Research
  • Regional Urology, LLC
  • Premier Urology Associates, LLC, dba AdvanceMed Research
  • The Urological Institute of Northeastern New York
  • AccuMed Research Associates
  • Bruce R. GIlbert, MD, PhD, PC
  • Manhattan Medical Research Practice PLLC
  • Volunteer Research
  • Clinical Research Associates, Inc.
  • Physicians' Research Options LLC
  • Clinical Research Associates of Tidewater, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fispemifene 450 mg

Placebo

Arm Description

Fispemifene capsules will be taken orally each morning immediately after eating a meal

Placebo capsules will be taken orally each morning immediately after eating a meal

Outcomes

Primary Outcome Measures

Change in IIEF-EF (International Index of Erectile Function - erectile function domain) score
Change in the IIEF-EF (International Index of Erectile Function - erectile function domain) score from Randomization to Week 8

Secondary Outcome Measures

Full Information

First Posted
May 11, 2015
Last Updated
November 11, 2015
Sponsor
NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
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1. Study Identification

Unique Protocol Identification Number
NCT02443090
Brief Title
Safety and Efficacy Study of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men
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 Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hypogonadism, Sexual Dysfunction, Erectile Dysfunction
Keywords
secondary hypogonadism, sexual dysfunction, erectile dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fispemifene 450 mg
Arm Type
Experimental
Arm Description
Fispemifene capsules will be taken orally each morning immediately after eating a meal
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules will be taken orally each morning immediately after eating a meal
Intervention Type
Drug
Intervention Name(s)
fispemifene
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in IIEF-EF (International Index of Erectile Function - erectile function domain) score
Description
Change in the IIEF-EF (International Index of Erectile Function - erectile function domain) score from Randomization to Week 8
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Troupin, MD, MBA
Organizational Affiliation
NexMed (U.S.A.), Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Baptist Health Center for Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
San Diego Clinical Trials
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Genesis Research LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Meridien Research
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Well Pharma Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Premier Urology Associates, LLC, dba AdvanceMed Research
City
Lawrence Township
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
The Urological Institute of Northeastern New York
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
AccuMed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Bruce R. GIlbert, MD, PhD, PC
City
Great Neck
State/Province
New York
ZIP/Postal Code
11022
Country
United States
Facility Name
Manhattan Medical Research Practice PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Volunteer Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Clinical Research Associates, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Physicians' Research Options LLC
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Clinical Research Associates of Tidewater, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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