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Oral Testosterone for the Treatment of Hypogonadism

NCT ID: NCT01717768

Last Updated: 2015-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-12-31

Brief Summary

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Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.

The purpose of this study is to evaluate the ability of TSX-002, which is testosterone provided in easy to swallow capsules, to maintain serum (blood) testosterone levels within the normal range in hypogonadal men. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of TSX-002, which will be taken orally twice per day for 15 days. In addition, the study is intended to determine a dosing regimen(s) that achieves testosterone levels within the normal range. Related Outcome Measures will be reported for Parts 1, 2, and 4.

A portion of the study (Part 3) to also assess the effect of a high-calorie, high-fat meal on the single dose pharmacokinetic exposure of TSX-002. Related outcome measures to be reported for Part 3.

Detailed Description

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Conditions

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Hypogonadism

Keywords

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hypogonadism Gonadal Disorders Endocrine System Diseases Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Anabolic Agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: 120 mg BID

Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days

Group Type EXPERIMENTAL

TSX-002

Intervention Type DRUG

TSX-002 are capsules with testosterone as the active ingredient.

Part 1: 240 mg BID

Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days

Group Type EXPERIMENTAL

TSX-002

Intervention Type DRUG

TSX-002 are capsules with testosterone as the active ingredient.

Part 2: 120 mg BID

Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days

Group Type EXPERIMENTAL

TSX-002

Intervention Type DRUG

TSX-002 are capsules with testosterone as the active ingredient.

Part 3: A-B-C 120 mg QD

Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.

* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.

Group Type EXPERIMENTAL

TSX-002

Intervention Type DRUG

TSX-002 are capsules with testosterone as the active ingredient.

Part 3: B-C-A 120 mg QD

Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.

* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.

Group Type EXPERIMENTAL

TSX-002

Intervention Type DRUG

TSX-002 are capsules with testosterone as the active ingredient.

Part 3: C-A-B 120 mg QD

Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.

* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.

Group Type EXPERIMENTAL

TSX-002

Intervention Type DRUG

TSX-002 are capsules with testosterone as the active ingredient.

Part 4 Cohort 1: 60 mg BID/ 60 mg TID

Oral TSX-002 60 mg BID for 15 days then 60 mg TID for 15 days

Group Type EXPERIMENTAL

TSX-002

Intervention Type DRUG

TSX-002 are capsules with testosterone as the active ingredient.

Part 4 Cohort 2: 90 mg BID/ 90 mg TID

Oral TSX-002 90 mg BID for 15 days then 90 mg TID for 15 days

Group Type EXPERIMENTAL

TSX-002

Intervention Type DRUG

TSX-002 are capsules with testosterone as the active ingredient.

Part 4 Cohort 3: 180 mg QD

Oral TSX-002 180 mg once daily (QD) for 15 days

Group Type EXPERIMENTAL

TSX-002

Intervention Type DRUG

TSX-002 are capsules with testosterone as the active ingredient.

Part 4 Cohort 4: 120 mg BID

Oral TSX-002 120 mg BID for 15 days

Group Type EXPERIMENTAL

TSX-002

Intervention Type DRUG

TSX-002 are capsules with testosterone as the active ingredient.

Interventions

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TSX-002

TSX-002 are capsules with testosterone as the active ingredient.

Intervention Type DRUG

Other Intervention Names

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Testosterone

Eligibility Criteria

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Inclusion Criteria

* Prior documentation of a diagnosis of hypogonadism as evidenced by a screening serum testosterone \< 300 ng/dL (based on the average of 2 morning samples taken at least 1 week apart)
* Men over the age of 18 years with a body mass index (BMI) \< 39.0 kg/m2 and weighing ≥ 55 kg
* Hemoglobin levels at screening and baseline \> 12.5 g/dL
* Testosterone treatment not contraindicated
* No evidence of suspected reversible hypogonadism
* Willing to abstain from current treatment for hypogonadism in accordance with approved labeling to facilitate an appropriate washout period before study participation (for nondepot formulations of testosterone only)
* Understands the requirements of the study and voluntarily consents to participate in the study

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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TesoRx Pharma, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Kowalczyk, DO, FACOS

Role: PRINCIPAL_INVESTIGATOR

Urology Group of Southern California

Locations

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Urology Group of Southern California

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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TT-002

Identifier Type: -

Identifier Source: org_study_id