Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
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.
Age
18–64
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible 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 be 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
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
Clareo Health | Safety and Efficacy Study of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men
