Safety and Efficacy Study of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men
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
1 other identifier
interventional
160
1 country
16
Brief Summary
To evaluate the safety and efficacy of fispemifene in men with secondary hypogonadism and sexual side effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2015
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 11, 2015
CompletedFirst Posted
Study publicly available on registry
May 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedNovember 13, 2015
November 1, 2015
5 months
May 11, 2015
November 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Fispemifene 450 mg
EXPERIMENTALFispemifene capsules will be taken orally each morning immediately after eating a meal
Placebo
PLACEBO COMPARATORPlacebo capsules will be taken orally each morning immediately after eating a meal
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205, United States
San Diego Clinical Trials
San Diego, California, 92120, United States
Genesis Research LLC
San Diego, California, 92123, United States
Meridien Research
Bradenton, Florida, 34208, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Well Pharma Medical Research
Miami, Florida, 33144, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
Premier Urology Associates, LLC, dba AdvanceMed Research
Lawrence, New Jersey, 08648, United States
The Urological Institute of Northeastern New York
Albany, New York, 12208, United States
AccuMed Research Associates
Garden City, New York, 11530, United States
Bruce R. GIlbert, MD, PhD, PC
Great Neck, New York, 11022, United States
Manhattan Medical Research Practice PLLC
New York, New York, 10016, United States
Volunteer Research
Knoxville, Tennessee, 37920, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203, United States
Physicians' Research Options LLC
Draper, Utah, 84020, United States
Clinical Research Associates of Tidewater, Inc.
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Barbara Troupin, MD, MBA
NexMed (U.S.A.), Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2015
First Posted
May 13, 2015
Study Start
May 1, 2015
Primary Completion
October 1, 2015
Study Completion
April 1, 2016
Last Updated
November 13, 2015
Record last verified: 2015-11