Status:
COMPLETED
Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men
Lead Sponsor:
Marius Pharmaceuticals
Collaborating Sponsors:
Syneos Health
Conditions:
Hypogonadism, Male
Eligibility:
MALE
18-65 years
Phase:
PHASE3
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 tit...
Detailed Description
This is the six-month treatment extension of Study MRS-TU-2019, which like Study MRS-TU-2019 (NCT03198728), is an open-label study. The MRS-TU-2019 ABPM Extension Study (MRS-TU-2019EXT; NCT04467697), ...
Eligibility Criteria
Inclusion
- For all subjects participating in MRS-TU-2019EXT, whether rolling over from MRS-TU-2019 (after washout) or newly enrolling, the following MRS-TU-2019EXT Inclusion/Exclusion Criteria apply:
- 1\. Completion of MRS-TU-2019 Day 365/ End of Treatment
Exclusion
- 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.
- For newly enrolling subjects into MRS-TU-2019EXT (naïve to MRS-TU-2019), the applicable Inclusion/Exclusion criteria from the MRS-TU-2019 study, also must be met :
- MRS-TU-2019 Key Inclusion Criteria:
- 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
- \*for MRS-TU-2019EXT ABPM Extension Study, the in-clinic, average BP must be \< 140/90 for inclusion into the MRS-TU-2019EXT study.
- 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.
- Adequate venous access to allow collection of a number of blood samples via a venous cannula.
- Written informed consent to participate in the study and ability to comply with all study requirements.
- MRS-TU-2019 Key
Key Trial Info
Start Date :
September 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT04467697
Start Date
September 18 2018
End Date
May 1 2020
Last Update
June 28 2024
Active Locations (19)
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1
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
2
Coastal Clinic Research Inc
Mobile, Alabama, United States, 36608
3
South Florida Medical Research
Aventura, Florida, United States, 33180
4
PAB Clinical Research
Brandon, Florida, United States, 33511