drugset / Trial / NCT02937740

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

NCT02937740

Phase 4 Completed 117 enrolled Acerus Pharmaceuticals Corporation
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2016-10
Primary completion
2017-10
Completion
2017-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Testosterone Small molecule 5.5 mg Intranasal

Indications