A 150-Day, Prospective, Phase 4, Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Testosterone Nasal Gel (Natesto™) (MyT)

NCT02937740 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Acerus Pharmaceuticals Corporation
Phase	Phase 4
Status	COMPLETED
Enrolment	117
Start date	2016-10
Completion	2017-11

Conditions

• Hypogonadism

Interventions

• NATESTO Testosterone Nasal Gel

Primary outcomes

• Patient Satisfaction - Change From Baseline — Baseline and 3 months for BID, 4 months for TID
  The primary objective of this study is to measure patient satisfaction with testosterone replacement therapy before, during and after treatment with NATESTO. Patient satisfaction with treatment will be measured by TSQM (Treatment Satisfaction Questionnaire for Medication) Version 9, a 9-item validated instrument. TSQM domains include - Effectiveness, Convenience, Global Satisfaction. The score for each domain is converted into a scale out of 100. Higher values imply a better outcome.

Countries

Canada