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

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02443090
• Other study ID #: NM-F15-202
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 11, 2015
• Last updated: November 11, 2015
• Start date: May 2015
• Est. completion date: April 2016

Study information

• Verified date: November 2015
• Source: NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: April 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Hypogonadism
• Secondary Hypogonadism
• Sexual Dysfunction

Intervention

Drug:
• fispemifene

Other:
• Placebo

Locations

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

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 weeks	No