NCT01403116

Brief Summary

The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
325

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2011

Geographic Reach
2 countries

30 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

Study Start

First participant enrolled

July 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
5 years until next milestone

Results Posted

Study results publicly available

August 14, 2018

Completed
Last Updated

August 14, 2018

Status Verified

July 1, 2018

Enrollment Period

2.2 years

First QC Date

July 25, 2011

Results QC Date

August 22, 2017

Last Update Submit

July 16, 2018

Conditions

Male Hypogonadism

Keywords

testosteronemale hypogonadismlow testosterone

Outcome Measures

Primary Outcomes (1)

  • Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL

    The percentages of treated subjects that had 24-hour serum testosterone (T) average concentrations (Cavg) between 300 and 1000 ng/dL

    Following 90 days of treatment

Secondary Outcomes (1)

  • % of Oral TU Subjects With 24-hour Maximum Serum T Concentrations (Cmax) Greater Than 1500 ng/dL on Day 90

    90 days

Study Arms (2)

Oral testosterone undecanoate (TU)

EXPERIMENTAL

Treatment Period 1: 100 mg capsules, BID, with food Treatment Period 2: One of the following dosages: * 100 mg BID * 150 mg BID * 100 mg BID * 100 mg and 150 mg BID * 150 mg capsules BID Safety Follow-up Phase: Initial dose: \~84 doses Maintenance dose-Titrated dose: \~96 doses Safety follow-up at maintenance dose: \~540 doses

Drug: Oral testosterone undecanoate

topical testosterone gel

ACTIVE COMPARATOR

Treatment Period 1: 5 g of 1% transdermal T-gel applied QD Treatment Period 2: * 2.5 g of 1% transdermal T-gel applied QD * 5 g of 1% transdermal T-gel applied QD * 7.5 g of 1% transdermal T-gel applied QD * 10 g of 1% transdermal T-gel applied QD Safety Follow-up Phase: Initial dose: \~42 doses Maintenance dose-Titrated dose: \~48 doses Safety follow-up at maintenance dose: \~270 doses

Drug: topical testosterone gel

Interventions

Oral testosterone undecanoateDRUG

Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.

Also known as: Oral TU
Oral testosterone undecanoate (TU)
topical testosterone gelDRUG

Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.

Also known as: T-gel
topical testosterone gel

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Serum testosterone of less than or equal to 300 ng/dL on two occasions within one week (may wash out from previous oral, topical or buccal testosterone therapy)

You may not qualify if:

  • Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease, or psychiatric illness
  • Recent history of stroke, not including transient ischemic attack
  • Untreated, sever obstructive sleep apnea.
  • Hematocrit \<35% or \>48
  • Serum transaminases \>2 times upper limit of normal, serum bilirubin \> 2.0 mg/dL and serum creatinine \> 2.0 mgk/dL
  • BMI \> or equal to 36
  • Stable doses of lipid-lowering medication for less than 3 months
  • Stable doses of oral medication for diabetes for less than 2 months
  • Abnormal prostate DRE \[palpable nodule(s)\], elevated PSA (\>4 ng/mL), IPSS score \> or equal to 19 points.
  • History of breast cancer
  • Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum testosterone within previous 4 weeks
  • Known malabsorption syndrome and/or current treatment with oral lipase inhibitors
  • History of abuse of alcohol or any drug substance within the previous 2 years
  • Current use of antiandrogens, estrogens, oral CYP3A4 inducers or inhibitors, or long-acting opioid analgesics
  • Receipt of any drug as part of a research study within 30 days of initial dose administration in this study.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Alabama Clinical Therapeutics, Inc.

Birmingham, Alabama, 35235, United States

Location

Alabama Internal Medicine, PC

Birmingham, Alabama, 35235, United States

Location

Alabama Clinical Therapeutics

Calera, Alabama, 35040, United States

Location

Medical Affliated Research Center, Inc.

Huntsville, Alabama, 35801, United States

Location

Quality of Life Medical and Research Centers, LLC

Tucson, Arizona, 85712, United States

Location

Providence Clinical Research

Burbank, California, 91505, United States

Location

South Orange County Endocrinology

Laguna Hills, California, 92653, United States

Location

Tower Urology

Los Angeles, California, 90048, United States

Location

David Geffen School of Medicine

Los Angeles, California, 90095, United States

Location

Harbor-UCLA Medical Center, LA Biomedical Research Institute

Torrance, California, 90502, United States

Location

Connecticut Clinical Research Center/ConnecTrials

Middlebury, Connecticut, 06762, United States

Location

University of CT School of Medicine

New Haven, Connecticut, 06511, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11235, United States

Location

Bruce R. Gilbert, MD, PhD

Great Neck, New York, 11021, United States

Location

University Urology Associates

New York, New York, 10016, United States

Location

Michael A. Werner, MD, PC

Purchase, New York, 10577, United States

Location

Sunstone Medical Research

Medford, Oregon, 97504, United States

Location

Urologic Consultants of Southeast Pennsylvania

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Research Across America

Carrollton, Texas, 75010, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

University of Bonn, Clinic for Dermatology and Allergy

Bonn, Germany

Location

University of Halle, Center for Reproduction and Androlgoy

Halle, Germany

Location

Praxis Dr. Szymula

Leipzig, Germany

Location

Praxis Dr. Schulze

Markkleeberg, Germany

Location

University of Muenster, Center for Reproduction and Andrology

Münster, Germany

Location

Related Publications (1)

  • Honig S, Gittelman M, Kaminetsky J, Wang C, Amory JK, Rohowsky N, Dudley RE, Woun Seo B, Newmark J, Swerdloff R. Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety. J Sex Med. 2022 Dec;19(12):1750-1758. doi: 10.1016/j.jsxm.2022.09.002. Epub 2022 Oct 20.

    PMID: 36272969DERIVED

MeSH Terms

Conditions

Eunuchism

Interventions

testosterone undecanoateCoal Tar

Condition Hierarchy (Ancestors)

HypogonadismGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TarsComplex Mixtures

Results Point of Contact

Title
Theodore Danoff, MD, PhD
Organization
Clarus Therapeutics
tdanoff@clarustherapeutics.com
847-562-4300

Study Officials

  • Ronald Swerdloff, MD

    Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2011

First Posted

July 27, 2011

Study Start

July 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

August 14, 2018

Results First Posted

August 14, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

No plan to share IPD

Locations

US(25)DE(5)