A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

NCT02722278 | Completed Phase 3 Results

• 1 other identifier: CLAR-15012
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Conditions

Hypogonadism

Outcome Measures

Primary Outcomes (1)

• Number of Oral TU Treated Subjects Who Have a Total T Cavg in the Eugonadal Range of 252 to 907 ng/dL at Visit 7

  Day 105

Other Outcomes (1)

• Number of Participants With Post-stimulation Cortisol Level of >18 ug/dL at Visit 8

  Approximately 4.5 months

Study Arms (2)

Oral Testosterone Undecanoate

EXPERIMENTAL

Approximately 135 subjects will receive oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).

Drug: Oral Testosterone Undecanoate

Axiron Testosterone Topical Solution

ACTIVE COMPARATOR

Subjects randomly assigned to the Axiron treatment group will begin treatment at a dose of 60 mg every morning.

Drug: Axiron Testosterone Topical Solution

Interventions

Oral Testosterone Undecanoate DRUG

Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.

Also known as: Oral TU

Oral Testosterone Undecanoate

Axiron Testosterone Topical Solution DRUG

Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.

Also known as: Axiron solution

Axiron Testosterone Topical Solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man 18 to 65 years of age, inclusive, with hypogonadism as defined by 2 AM total T values of \<300 ng/dL drawn on 2 separate days (\[approximately 7 days apart\]).
• Adequate venous access
• Must be naïve to androgen-replacement therapy or washed out of prior androgen replacement therapies; willing to cease current T treatment or currently not be taking T treatment. Subjects must remain off all forms of T, except for dispensed study drug, throughout the entire study.
• Subjects on replacement therapy for hypopituitarism or multiple endocrine deficiencies must be on stable doses of thyroid hormone and adrenal replacement hormones for at least 14 days before Screen 1.
• Voluntarily given written informed consent to participate in this study.

You may not qualify if:

• 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.
• Received oral TU in a previous Clarus-sponsored investigational study.
• Significant intercurrent disease of any type; in particular, liver, kidney, uncontrolled or poorly controlled heart disease, including hypertension, congestive heart failure or coronary heart disease, or psychiatric-illness, including severe depression.
• Recent (within 2 years) history of stroke, transient ischemic attack, or acute coronary event.
• A mean of the triplicate assessment of systolic blood pressure (sBP) \> 150 mm Hg and/or diastolic blood pressure (dBP) \> 90 mm Hg at screening.
• Recent (within 2 years) history of angina or stent (coronary or carotid) placement.
• Untreated, severe obstructive sleep apnea.
• Clinically significant abnormal laboratory values (serum transaminases \> 2 × ULN, serum bilirubin \> 1.5 × ULN and serum creatinine \> 1.5 × ULN).
• Hematocrit (HCT) value of \< 35% or \> 48%.
• Has a history of polycythemia, either idiopathic or associated with testosterone replacement therapy (TRT).
• Glycosylated hemoglobin (A1C) \> 8.5%.
• BMI ≥ 38 kg/m2.
• If receiving the following medications:
• Has been on stable doses of lipid-lowering medication for \< 3 months;
• Has been on stable doses of oral medication for diabetes for \< 2 months; or

Sponsors & Collaborators

• Clarus Therapeutics, Inc.: lead
• Syneos Health: collaborator

Study Sites (1)

Multiple Sites in the United States

Northbrook, Illinois, 60062, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Theodore Danoff, MD, PhD
• Organization: Clarus Therapeutics

tdanoff@clarustherapeutics.com

847-562-4300

Study Officials

• Ronald Swerdloff, MD

  Primary Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: March 29, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 23, 2018
• Results First Posted: February 23, 2018

Record last verified: 2018-01

Locations

US (1)