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Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01403116
Recruitment Status : Completed
First Posted : July 27, 2011
Results First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Collaborators:
PharmaNet
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Information provided by (Responsible Party):
Clarus Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Male Hypogonadism Drug: Oral testosterone undecanoate Drug: topical testosterone gel Phase 3

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Study Start Date : July 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013


Arm Intervention/treatment
Experimental: Oral testosterone undecanoate (TU)

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
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.
Other Name: Oral TU

Active Comparator: topical testosterone gel

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
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.
Other Name: T-gel




Primary Outcome Measures :
  1. Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL [ Time Frame: Following 90 days of treatment ]
    The percentages of treated subjects that had 24-hour serum testosterone (T) average concentrations (Cavg) between 300 and 1000 ng/dL


Secondary Outcome Measures :
  1. % of Oral TU Subjects With 24-hour Maximum Serum T Concentrations (Cmax) Greater Than 1500 ng/dL on Day 90 [ Time Frame: 90 days ]
    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%).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403116


Locations
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Sponsors and Collaborators
Clarus Therapeutics, Inc.
PharmaNet
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Investigators
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Principal Investigator: Ronald Swerdloff, MD Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Responsible Party: Clarus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01403116    
Other Study ID Numbers: CLAR-09007
First Posted: July 27, 2011    Key Record Dates
Results First Posted: August 14, 2018
Last Update Posted: August 14, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD
Keywords provided by Clarus Therapeutics, Inc.:
testosterone
male hypogonadism
low testosterone
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents