Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

155

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Sep 2018

Geographic Reach

1 country

19 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

Study Start

First participant enrolled

September 18, 2018

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2020

Completed

12 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed

4 years until next milestone

Results Posted

Study results publicly available

June 28, 2024

Completed

Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

1.6 years

First QC Date

July 1, 2020

Results QC Date

April 17, 2024

Last Update Submit

June 5, 2024

Conditions

Hypogonadism, Male

Outcome Measures

Primary Outcomes (2)

Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 120 Days Treatment
Change from baseline in 24-hour Ambulatory Systolic Blood Pressure (sBP) after approximately 120 days treatment (Mixed Model Repeated Measures analysis).
120 days
Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration
Percentage of SOV2012-F1-treated subjects with a plasma NaF/EDTA plasma testosterone (T) Cavg within the normal range after 90 days of treatment using up- and down-titration as appropriate. Measured by Plasma T concentration using a starting daily dose of 400 mg SOV2012-F1.
90 days

Secondary Outcomes (8)

Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment.
120 and 180 days
Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment.
120 and 180 days
Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment.
120 and 180 days
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
120 and 180 days
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
120 and 180 days
+3 more secondary outcomes

Other Outcomes (11)

AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects.
180 days
Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement.
Baseline, 90, 119 and 179 days
Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period.
Baseline, 90, 119 and 179 days
+8 more other outcomes

Study Arms (1)

SOV2012-F1-treated

EXPERIMENTAL

Patients treated with SOV2012-F1, starting daily dose in MRS-TU-2019EXT is 400 mg - (200 mg with morning meal and 200 mg with evening meal). Dosing is titrated up to a maximum of 800 mg SOV2012-F1 per day (400 mg in the morning and 400 mg in the evening) or titrated down to a minimum of 100 mg SOV2012-F1 per day (100 mg in the morning) based on plasma T after 14 and 42 days of treatment, intermediate dose levels include total daily doses of 600 mg, 400 mg and 200 mg.

Drug: SOV2012-F1

Interventions

SOV2012-F1DRUG

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

SOV2012-F1-treated

Eligibility Criteria

Age18 Years - 65 Years

Sexmale(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

\. Completion of MRS-TU-2019 Day 365/ End of Treatment
Upper arm circumference \> 45 cm.
Long distance driving or planned driving trip (\> 60 mins duration where the subject is doing the driving) during period of wearing ABPM cuff.
Expected / known forthcoming change to antihypertensive medication(s) during the MRS-TU-2019 EXT extension study.
Cardiac arrhythmias that, in the opinion of the investigator, interfere with the ability of the ABPM recorder to obtain reliable measurements.
Use of T implantable pellets since completion of Day 365/EOT visit in MRS-TU- 2019.
Male aged 18 to 65 years, inclusive, at the time of providing informed consent to participate in the study.
Hypogonadism defined as having 2 consecutive serum total T levels ≤ 281 ng/dL based on a blood sample, drawn at least 3 days apart, between 7 a.m. and 10 a.m.
At least 1 clinical feature consistent with male hypogonadism. If a subject is receiving commercial TRT prior to Screening Visit 1, he must have a history of at least 1 clinical feature consistent with male hypogonadism.
Must be naïve to androgen replacement therapy or washed out adequately of prior androgen replacement therapies; willing to cease current T treatment; or currently not taking any T treatment. Subjects must remain off all forms of T, except for dispensed study drug, throughout the entire study.
No unstable ongoing concomitant medical conditions. Treated and well-controlled conditions such as type 2 diabetes, hypertension, or dyslipidemia are acceptable with stable medication in place for at least 3 months prior to study entry:
Hemoglobin A1c \< 8.0%
BP \< 150/90 mm Hg
Low-density lipoprotein cholesterol \< 190 mg/dL.
Subjects with an endocrine disorder requiring treatment other than hypogonadism must be on a stable dose of replacement medication for at least 3 months prior to study entry.
+35 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Marius Pharmaceuticalslead
Syneos Healthcollaborator

Study Sites (19)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

Coastal Clinic Research Inc

Mobile, Alabama, 36608, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

PAB Clinical Research

Brandon, Florida, 33511, United States

Location

Jacksonville Impotence Treatment Center

Jacksonville, Florida, 32223, United States

Location

My Community Research Center

Miami, Florida, 33155, United States

Location

Oviedo Medical Research, LLC

Oviedo, Florida, 32765, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

Northwest Clinical Trials

Boise, Idaho, 83704, United States

Location

Centex Studies, Inc.

Lake Charles, Louisiana, 70601, United States

Location

Quality Clinical Research, Inc.

Omaha, Nebraska, 68114, United States

Location

Palm Research Center, Inc.

Las Vegas, Nevada, 89148, United States

Location

Accumed Research Associates

Garden City, New York, 11530, United States

Location

Manhattan Medical Research Practice, PLLC

New York, New York, 10016, United States

Location

Rapha Institute for Clinical Research

Fayetteville, North Carolina, 28314, United States

Location

Urologic Consultant of SE Pennyslvania

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

University Diabetes Endocrine Consultants

Chattanooga, Tennessee, 37411, United States

Location

Centex Studies, Inc.

Houston, Texas, 77058, United States

Location

Related Publications (1)

Bernstein JS, Dhingra OP. A phase III, single-arm, 6-month trial of a wide-dose range oral testosterone undecanoate product. Ther Adv Urol. 2024 Apr 10;16:17562872241241864. doi: 10.1177/17562872241241864. eCollection 2024 Jan-Dec.
PMID: 38606384DERIVED

MeSH Terms

Conditions

Eunuchism

Condition Hierarchy (Ancestors)

HypogonadismGonadal DisordersEndocrine System Diseases

Results Point of Contact

Title: Nita Nimmons
Organization: Marius Pharmaceuticals, LLC

Study Officials

Alistair Smith, MB, ChB
Syneos Health
STUDY DIRECTOR
Om Dhingra, PhD
Marius Pharmaceuticals
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 13, 2020

Study Start

September 18, 2018

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

June 28, 2024

Results First Posted

June 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing: Will not share

Locations

US(19)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Other Outcomes (11)

Study Arms (1)

SOV2012-F1-treated

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (19)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Other Outcomes (11)

Study Arms (1)

SOV2012-F1-treated

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (19)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations