CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 155 enrolled
Drug / intervention
SOV2012-F1drug
Likely dose
SOV2012-F1 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04467697
NCT04467697Phase 3Completed
CompareCT.gov

A 6 Month, Open Label, Ambulatory Blood Pressure Monitoring (ABPM) Extension Study

Marius Pharmaceuticals·interventional·Posted Jul 13, 2020·Updated Jun 28, 2024

In Brief

A Phase 3 clinical trial evaluating SOV2012-F1 for Hypogonadism, Male. Completed, enrolled 155 participants across 19 sites.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadism, Male
CountriesUnited States
CollaboratorsSyneos Health

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 13, 2020
Enrollment StartSep 18, 2018
Primary CompletionMay 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.0 years ago

Interventions

SOV2012-F1drug

Oral preparation of testosterone undecanoate (TU). Strengths of 100 mg TU, 150 mg TU and 200 mg TU