Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01403116
Other study ID # CLAR-09007
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 2011
Est. completion date September 2013

Study information

Verified date July 2018
Source Clarus Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This was a randomized, open-label, 2-arm, active controlled, 12-month study of Oral TU that planned to enroll ≈ 300 hypogonadal men (≈ 150/group) at multiple study sites. Incorporated in the design was dose titration based on serum T concentration assessed 4-6 hrs post AM dose. Following a 2-visit screening period during which a serum T concentration was measured, eligible subjects were randomized to either Oral TU (Group A) or transdermal T-gel (Group B) for dosing during Treatment Period 1 (Days 0 to 42). Group A was initially dosed with 400 mg T daily (two 100 mg capsules, orally, twice a day [BID]), and Group B was initially dosed with 5 g of transdermal 1% T-gel.

Serum T sampling was done on Day 30, 4-6 hours after the morning dose and these T concentration results were used to determine the need for dose titration. Dose titration occurred on Day 42 for Treatment Period 2, until Day 90. Subjects whose dose was titrated on Day 42 were re-evaluated on Day 60 , with dose adjustments made as necessary on Day 74.

Serum T sampling was performed on Day 90, for Oral TU subjects who had dose titration on Day 74, on Day 105. If the serum T level was > 1800 ng/dL, the sample was repeated; subjects were discontinued if the second assayed T concentration was > 1800 ng/dL. An additional dose titration was done for subjects whose Day 180 occurred after a protocol amendment. Subjects taking 150 mg T BID with serum T over 1500 ng/dL on two separate draws were discontinued.

Safety measures included physical examination, vital signs, fasting laboratory analysis (hematology, chemistry, urinalysis), CV biomarker monitoring [hs-CRP, Lp-PLA2, Lp(a), and ApoA1], measurement of sex hormone binding globulin (SHBG); luteinizing hormone (LH), follicle-stimulating hormone (FSH); prostate specific antigen (PSA), and the American Urological Association/International Prostate Symptom Score (AUA/I-PSS).


Recruitment information / eligibility

Status Completed
Enrollment 325
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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.

- Blood donation within the 12 week period before the initial study dose.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Oral testosterone undecanoate
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.
topical testosterone gel
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.

Locations

Country Name City State
Germany University of Bonn, Clinic for Dermatology and Allergy Bonn
Germany University of Halle, Center for Reproduction and Androlgoy Halle
Germany Praxis Dr. Szymula Leipzig
Germany Praxis Dr. Schulze Markkleeberg
Germany University of Muenster, Center for Reproduction and Andrology Muenster
United States South Florida Medical Research Aventura Florida
United States Urologic Consultants of Southeast Pennsylvania Bala-Cynwyd Pennsylvania
United States Johns Hopkins University Baltimore Maryland
United States Alabama Clinical Therapeutics, Inc. Birmingham Alabama
United States Alabama Internal Medicine, PC Birmingham Alabama
United States Boston University School of Medicine Boston Massachusetts
United States Maimonides Medical Center Brooklyn New York
United States Providence Clinical Research Burbank California
United States Alabama Clinical Therapeutics Calera Alabama
United States Research Across America Carrollton Texas
United States Research Across America Dallas Texas
United States Bruce R. Gilbert, MD, PhD Great Neck New York
United States Medical Affliated Research Center, Inc. Huntsville Alabama
United States South Orange County Endocrinology Laguna Hills California
United States David Geffen School of Medicine Los Angeles California
United States Tower Urology Los Angeles California
United States University of Louisville Louisville Kentucky
United States Sunstone Medical Research Medford Oregon
United States Connecticut Clinical Research Center/ConnecTrials Middlebury Connecticut
United States University of CT School of Medicine New Haven Connecticut
United States University Urology Associates New York New York
United States Michael A. Werner, MD, PC Purchase New York
United States University of Washington Seattle Washington
United States Harbor-UCLA Medical Center, LA Biomedical Research Institute Torrance California
United States Quality of Life Medical and Research Centers, LLC Tucson Arizona

Sponsors (3)

Lead Sponsor Collaborator
Clarus Therapeutics, Inc. Los Angeles Biomedical Research Institute, PharmaNet

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 % of Oral TU Subjects With 24-hour Maximum Serum T Concentrations (Cmax) Greater Than 1500 ng/dL on Day 90 Percentage of Oral TU treated patients who reached study day 90 and had a maximum serum T concentrations (Cmax) values greater than 1500 ng/dL(objective to meet <15%). 90 days
See also
  Status Clinical Trial Phase
Completed NCT01446042 - Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism Phase 3
Completed NCT02966652 - Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism Phase 1
Completed NCT01228071 - Time to Eugonadal Range, Time to Steady State and Drying Time Phase 3
Withdrawn NCT02715713 - Autonomic Manifestations of Testosterone Deficiency in Men N/A
Completed NCT00858650 - Registry of Hypogonadism in Men N/A
Recruiting NCT05541172 - Testosterone Undecanoate Replacement Therapy in Boys With Pubertal Delay or Confirmed Hypogonadism
Not yet recruiting NCT04704141 - Relationship of the Microenvironment and Male Fertility
Completed NCT00911586 - Pharmacokinetic Study to Determine Time to Steady-state Phase 2
Completed NCT00924612 - Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation Phase 2
Completed NCT01765179 - Safety and Efficacy Trial of Testosterone Undecanoate Phase 3
Completed NCT00475501 - 5-Alpha Reductase and Anabolic Effects of Testosterone Phase 2
Completed NCT04708249 - D-chiroinositol Administration in Hypogonadal Males N/A
Completed NCT02081300 - Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism Phase 3
Active, not recruiting NCT03721497 - Testosterone in Bariatric Patients Phase 4
Completed NCT01699178 - Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men Phase 3