Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natesto™

PHASE4CompletedINTERVENTIONAL
Enrollment

117

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

October 31, 2017

Study Completion Date

November 30, 2017

Conditions
Hypogonadism
Interventions
DRUG

NATESTO Testosterone Nasal Gel

"Participants will be instructed to administer 5.5 mg of testosterone (1 actuation) per nostril of NATESTO Testosterone Nasal Gel once in the morning and once in the evening (at least 6 hours apart), preferably at the same time each day for a total daily dose of 22 mg/day of testosterone. Patients should be instructed to completely depress the pump 1 time in each nostril to receive the total dose.~For three times daily (after Visit 4 \[Day 90\] if symptoms not adequately managed by a BID dose), NATESTO will be administered intranasally once in the morning, once in the afternoon and once in the evening (approximately 6-8 hours apart), preferably at the same time each day for a total daily dose of 33 mg/day of testosterone."

Trial Locations (11)

T2V 1P9

Prostate Cancer Centre - Research, Calgary

V8T 2C1

Silverado Research Inc., Victoria

L4M 7G1

LMC Barrie, Barrie

L7N 3V2

G. Kenneth Jansz Medicine Professional Corporation, Burlington

N6A 4V2

Lawson Research Institute / St Joseph's Health Care London, London

L6H 3P1

The Fe/Male Health Centre, Oakville

M6A 3B5

Toronto Urology Clinical Study Group, Toronto

N8X 3V6

Rabih Nour Clinic Windsor, Windsor

H9R 4S3

Ultra-Med Inc., Pointe-Claire

G1H 6P3

Clinique D'Andropause de Quebec, Québec

H4G 1E2

Dr. Carlos Marois Urologue, Verdun

All Listed Sponsors
lead

Acerus Pharmaceuticals Corporation

INDUSTRY