Overview

This trial is active, not recruiting.

Conditions secondary hypogonadism, sexual dysfunction, erectile dysfunction
Treatments fispemifene, placebo
Phase phase 2
Sponsor NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
Start date May 2015
End date October 2015
Trial size 160 participants
Trial identifier NCT02443090, NM-F15-202

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Fispemifene capsules will be taken orally each morning immediately after eating a meal
fispemifene
(Placebo Comparator)
Placebo capsules will be taken orally each morning immediately after eating a meal
placebo

Primary Outcomes

Measure
Change in IIEF-EF (International Index of Erectile Function - erectile function domain) score
time frame: 8 weeks

Eligibility Criteria

Male participants from 18 years up to 64 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.).