Clinical trial NCT01403116
Conditions: Male Hypogonadism
Keywords: testosterone male hypogonadism low testosterone
Sponsor: Clarus Therapeutics, Inc.
Start date: 2011-07-01; Completion date: 2013-09-01
Enrollment: 325 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

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).

Arms: arm 1: 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 arm 2: 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
Interventions: intervention 1: Oral testosterone undecanoate intervention 2: topical testosterone gel
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol documents: