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

NCT04467697 PHASE3 COMPLETED Results posted

The purpose of this six-month treatment 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 to further enhance efficacy and safety. * To examine the blood pressure (BP) effects of Marius's oral testosterone undecanoate formulation, SOV2012-F1, using 24-hour ambulatory blood pressure monitoring (ABPM).

Details

Lead sponsor	Marius Pharmaceuticals
Phase	PHASE3
Status	COMPLETED
Enrolment	155
Start date	Tue Sep 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri May 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Hypogonadism, Male

Interventions

• SOV2012-F1

Countries

United States