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

NCT02937740 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2019-08-12

Study results available
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Summary

Multicenter study consisting of two study periods as follows: a 90-day Treatment Period, with potential extension by 30 days for those patients requiring a dose increase, as determined by the treating physician. Participants receiving 122.5mg of NATESTO (5.5 mg of testosterone) per nostril twice daily may have an increased daily dose adjustment on Day 90, based on their hypogonadism symptoms.

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.

Sponsors & Collaborators

  • Acerus Pharmaceuticals Corporation

    lead INDUSTRY

Principal Investigators

  • Nathan Bryson, Ph.D. · Sponsor GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-10-31
Completion
2017-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02937740 on ClinicalTrials.gov