Clinical trial NCT02443090: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Secondary Hypogonadism
Sexual Dysfunction
Erectile Dysfunction
Keywords: secondary hypogonadism
sexual dysfunction
erectile dysfunction
Lead sponsor: NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
Sponsor class: INDUSTRY
First posted: 2015-05-13
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in IIEF-EF (International Index of Erectile Function - erectile function domain) score
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: San Diego
country: United States
facility: San Diego Clinical Trials
state: California
city: San Diego
country: United States
facility: Genesis Research LLC
state: California
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research
state: Florida
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Lawrence Township
country: United States
facility: Premier Urology Associates, LLC, dba AdvanceMed Research
state: New Jersey
city: Albany
country: United States
facility: The Urological Institute of Northeastern New York
state: New York
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: Great Neck
country: United States
facility: Bruce R. GIlbert, MD, PhD, PC
state: New York
city: New York
country: United States
facility: Manhattan Medical Research Practice PLLC
state: New York
city: Knoxville
country: United States
facility: Volunteer Research
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Draper
country: United States
facility: Physicians' Research Options LLC
state: Utah
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater, Inc.
state: Virginia
Study officials:
affiliation: NexMed (U.S.A.), Inc.
name: Barbara Troupin, MD, MBA
role: STUDY_DIRECTOR
References: