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

Sponsor
NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.) (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02443090
Collaborator
(none)
160
Enrollment
16
Locations
2
Arms
11
Duration (Months)
10
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Anticipated 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 1, 2015
Actual Primary Completion Date :
Oct 1, 2015
Anticipated Study Completion Date :
Apr 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in IIEF-EF (International Index of Erectile Function - erectile function domain) score [8 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baptist Health Center for Clinical Research Little Rock Arkansas United States 72205
2 San Diego Clinical Trials San Diego California United States 92120
3 Genesis Research LLC San Diego California United States 92123
4 Meridien Research Bradenton Florida United States 34208
5 Clinical Research of South Florida Coral Gables Florida United States 33134
6 Well Pharma Medical Research Miami Florida United States 33144
7 Regional Urology, LLC Shreveport Louisiana United States 71106
8 Premier Urology Associates, LLC, dba AdvanceMed Research Lawrence Township New Jersey United States 08648
9 The Urological Institute of Northeastern New York Albany New York United States 12208
10 AccuMed Research Associates Garden City New York United States 11530
11 Bruce R. GIlbert, MD, PhD, PC Great Neck New York United States 11022
12 Manhattan Medical Research Practice PLLC New York New York United States 10016
13 Volunteer Research Knoxville Tennessee United States 37920
14 Clinical Research Associates, Inc. Nashville Tennessee United States 37203
15 Physicians' Research Options LLC Draper Utah United States 84020
16 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

  • Study Director: Barbara Troupin, MD, MBA, NexMed (U.S.A.), Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
ClinicalTrials.gov Identifier:
NCT02443090
Other Study ID Numbers:
  • NM-F15-202
First Posted:
May 13, 2015
Last Update Posted:
Nov 13, 2015
Last Verified:
Nov 1, 2015
Keywords provided by NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
secondary hypogonadism
sexual dysfunction
erectile dysfunction
Additional relevant MeSH terms:
Erectile Dysfunction
Hypogonadism

Study Results

No Results Posted as of Nov 13, 2015