Overview

Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men

Status:
Completed
Trial end date:
2020-05-01
Target enrollment:
Participant gender:
Summary
The purpose of this six-month treatment extension study is - to assess feasibility of a lower starting dose of SOV2012-F1 (daily dose of 400 mg [200 mg with breakfast meal and 200mg with dinner meal]) to titrate individual doses in order to further enhance drug administration. - To examine the blood pressure (BP) effects of Marius's oral testosterone undecanoate formulation, SOV2012-F1, using 24-hour ambulatory blood pressure monitoring (ABPM).
Phase:
Phase 3
Details
Lead Sponsor:
Marius Pharmaceuticals
Collaborator:
Syneos Health