Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
|ClinicalTrials.gov Identifier: NCT01403116|
Recruitment Status : Completed
First Posted : July 27, 2011
Results First Posted : August 14, 2018
Last Update Posted : August 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Male Hypogonadism||Drug: Oral testosterone undecanoate Drug: topical testosterone gel||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||325 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Oral testosterone undecanoate (TU)
Treatment Period 1: 100 mg capsules, BID, with food
Treatment Period 2: One of the following dosages:
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:
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
- 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
- % 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%).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403116
|Principal Investigator:||Ronald Swerdloff, MD||Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center|