Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men
A 12-Month, Randomized, Active-controlled, Open-label Study of the Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men (RE-TUne)
1 other identifier
interventional
314
1 country
36
Brief Summary
This will be a randomized, multicenter, open-label, active-controlled, efficacy, and safety study in adult hypogonadal men. The study duration is 12 months (365 days), including a 90-day, open-label efficacy period and a 9-month (275-day) safety evaluation period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2017
Typical duration for phase_3
36 active sites
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
First Submitted
Initial submission to the registry
June 21, 2017
CompletedFirst Posted
Study publicly available on registry
June 26, 2017
CompletedStudy Start
First participant enrolled
July 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedResults Posted
Study results publicly available
June 28, 2023
CompletedJune 28, 2023
June 1, 2023
2.8 years
June 21, 2017
February 27, 2023
June 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Male Hypogonadal Subjects With Average NaF/EDTA Plasma Total Testosterone (T Cavg) Within the Normal Range Using Oral SOV2012-F1.
Efficacy assessment includes T Cavg calculated from NaF/EDTA plasma testosterone. The T Cavg is calculated as the 24-hour area under the curve (AUC), divided by 24, at Day 90, based on a fifteen blood samples (PK samples) taken over the 24-hours. The T concentration in each sample is measured using a validated LC-MS/MS method. The use of NaF/EDTA plasma tubes chilled after sample collection provides the most accurate values, as the prodrug TU may degrade post-sample collection, artificially inflating testosterone values.
90 days
Secondary Outcomes (1)
Percentages of Participants in Each Category for Maximum Plasma Concentration
90 days
Other Outcomes (16)
Change From Baseline in the IPSS
Baseline (pre-treatment) to 90 days and 365 days
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Baseline (pre-treatment) to 90 days and 365 days
Change From Baseline in the SF-36
Baseline (Day 1, pre-treatment) and change from baseline at the End of Treatment (EOT)
- +13 more other outcomes
Study Arms (2)
SOV2012-F1-treated
EXPERIMENTAL200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated on Days 28 and 56 up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
Andro-Gelâ„¢ treated
ACTIVE COMPARATOR100 patients treated with AndroGel, starting dose of 40.5 mg QD. Dose titrated according to approved label, using samples from Days 14 and 42 and dose adjustments on Days 28 and 56.
Interventions
Eligibility Criteria
You may qualify if:
- 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 naĂ¯ve 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.
- 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.
You may not qualify if:
- Serum PSA \> 2.5 ng/ml and/or abnormal prostate gland on palpation, eg, palpable nodes, at Screening Visit 2.
- Received oral, topical, intranasal, or buccal T therapy within the previous 2 weeks, intramuscular T injection of short-acting duration within the previous 4 weeks, intramuscular T injection of long-acting duration within the previous 20 weeks, or T implantable pellets within the previous 6 months.
- Use of any drug that could interfere with measurement or assessment of serum androgen levels, including 5 alpha-reductase inhibitors, anabolic steroids, and drugs with antiandrogenic properties (eg, spironolactone, cimetidine, flutamide, bicalutamide, and ketoconazole). These drugs must be stopped for at least 1 month prior to study entry (6 months in the case of dutasteride). Patients taking potent, long-acting opiate therapy on a daily basis are not eligible for the study. Conversely, ad hoc use of potent, short-acting opiates for a period of less than 7 days may be permitted after discussion with the Marius Pharmaceuticals medical monitor.
- Use of over-the-counter products, including natural health products (eg, food supplements and herbal supplements such as saw palmetto or phytoestrogens) that may affect total T levels, within 7 days prior to study entry.
- History of drug or alcohol abuse within the past 2 years that in the opinion of the investigator could interfere with study participation and/or influence study efficacy and safety endpoints assessments.
- Unstable or chronic disease that could interfere with participation in the study or patient safety, including psychiatric disorders.
- Myocardial infarction, coronary artery surgery, heart failure, stroke, unstable angina, or other unstable cardiovascular disease within the past 6 months.
- Abnormal ECG considered clinically significant by investigator at Screening.
- Diagnosis of any cancer within the previous 5 years other than basal or squamous cell skin cancer with clear margins.
- Any surgical or medical condition that might alter administration of the study drug or comparator, including history of gastric surgery, cholecystectomy, vagotomy, bowel resection, or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption of TU.
- Duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to screening.
- Chronic skin conditions on the chest or upper arms that would prevent administration of AndroGel in a manner designed to ensure reliable and consistent absorption thereof.
- Human immunodeficiency virus (HIV) infection.
- Chronic hepatitis B virus and/or hepatitis C virus (HCV) infection (as determined by positive testing for hepatitis B virus surface antigen or HCV antibody with confirmatory testing, ie, detectable serum HCV ribonucleic acid \[RNA\]).
- Clinically significant abnormal laboratory values at screening including but not limited to:
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marius Pharmaceuticalslead
- Syneos Healthcollaborator
Study Sites (36)
Central Research Associates, Inc.
Birmingham, Alabama, 35205, United States
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Quality of Life Medical and Research Centers, LLC
Tucson, Arizona, 85712, United States
San Diego Sexual Medicine
San Diego, California, 92120, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
PAB Clinical Research
Brandon, Florida, 33511, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
Jacksonville Impotence Treatment Center
Jacksonville, Florida, 32223, United States
Health Awareness, Inc.
Jupiter, Florida, 33458, United States
Meridien Research
Lakeland, Florida, 33805, United States
My Community Research Center
Miami, Florida, 33155, United States
Oviedo Medical Research, LLC
Oviedo, Florida, 32765, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Primary Care Research Group
Atlanta, Georgia, 30312, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Central Kentucky Research Associates
Lexington, Kentucky, 40509, United States
Centex Studies, Inc.
Lake Charles, Louisiana, 70601, United States
Men's Health Boston
Chestnut Hill, Massachusetts, 02467, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Palm Research Center, Inc.
Las Vegas, Nevada, 89148, United States
Accumed Research Associates
Garden City, New York, 11530, United States
Manhattan Medical Research Practice, PLLC
New York, New York, 10016, United States
Rapha Institute For Clinical Research
Fayetteville, North Carolina, 28314, United States
Aventiv Research, Inc.
Columbus, Ohio, 43213, United States
Urologic Consultants of SE Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
University Diabetes Endocrine Consultants
Chattanooga, Tennessee, 37411, United States
Centex Studies, Inc.
Houston, Texas, 77058, United States
Pioneer Research Solutions, Inc.
Houston, Texas, 77099, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
National Clinical Research, Inc.
Richmond, Virginia, 23294, United States
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057, United States
Mid-Columbia Research
Richland, Washington, 99352, United States
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nita Nimmons
- Organization
- Marius Pharmaceuticals, LLC
Study Officials
- STUDY DIRECTOR
Alastair Smith, MB, ChB
Syneos Health
- STUDY CHAIR
Om Dhingra, PhD
Marius Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Open label
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2017
First Posted
June 26, 2017
Study Start
July 5, 2017
Primary Completion
May 1, 2020
Study Completion
May 1, 2020
Last Updated
June 28, 2023
Results First Posted
June 28, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share