Oral Testosterone for the Treatment of Hypogonadism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TesoRx Pharma, LLC
ClinicalTrials.gov Identifier:
NCT01717768
First received: October 25, 2012
Last updated: December 14, 2015
Last verified: December 2015
  Purpose

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.


Condition Intervention Phase
Hypogonadism
Drug: TSX-002
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Dose Response Study of Oral Testosterone in Subjects With Hypogonadism

Resource links provided by NLM:


Further study details as provided by TesoRx Pharma, LLC:

Primary Outcome Measures:
  • Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range of 300 to 1050 ng/dL After 15 Days of Treatment With TSX-002 [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    Percentage of subjects achieving a 24-hour average total serum testosterone concentration (Cavg,0-24h) in the range of 300 to 1050 ng/dL after 15 days of treatment with TSX-002. PK samples taken at 0 ,2 ,4, 5 ,6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8 ,12, 13, 14, 15, 16, 17, 18, 20, 24 hours post-dose after 15 days of treatment for Part 4.


Secondary Outcome Measures:
  • Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax > 2500 ng/dL After 15 Days of BID Treatment [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    Cmax. PK samples taken at 0, 2, 4, 5, 6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 13, 14, 15, 16, 17,18, 20, 24 hours post-dose after 15 days of treatment for Part 4.


Other Outcome Measures:
  • Cavg 0-24 Hrs (ng/dL) After 120 mg Dose [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3. Mean of Cavg values from all time points for 14 subjects.

  • AUC 0-24 Hrs After 120 mg Dose of TSX-002 [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    AUC 0-24 hrs with PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3.


Enrollment: 130
Study Start Date: October 2012
Study Completion Date: December 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: 120 mg BID
Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
Drug: TSX-002
TSX-002 are capsules with testosterone as the active ingredient.
Other Name: Testosterone
Experimental: Part 1: 240 mg BID
Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days
Drug: TSX-002
TSX-002 are capsules with testosterone as the active ingredient.
Other Name: Testosterone
Experimental: 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
Drug: TSX-002
TSX-002 are capsules with testosterone as the active ingredient.
Other Name: Testosterone
Experimental: 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.
Drug: TSX-002
TSX-002 are capsules with testosterone as the active ingredient.
Other Name: Testosterone
Experimental: 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.
Drug: TSX-002
TSX-002 are capsules with testosterone as the active ingredient.
Other Name: Testosterone
Experimental: 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.
Drug: TSX-002
TSX-002 are capsules with testosterone as the active ingredient.
Other Name: Testosterone
Experimental: 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
Drug: TSX-002
TSX-002 are capsules with testosterone as the active ingredient.
Other Name: Testosterone
Experimental: 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
Drug: TSX-002
TSX-002 are capsules with testosterone as the active ingredient.
Other Name: Testosterone
Experimental: Part 4 Cohort 3: 180 mg QD
Oral TSX-002 180 mg once daily (QD) for 15 days
Drug: TSX-002
TSX-002 are capsules with testosterone as the active ingredient.
Other Name: Testosterone
Experimental: Part 4 Cohort 4: 120 mg BID
Oral TSX-002 120 mg BID for 15 days
Drug: TSX-002
TSX-002 are capsules with testosterone as the active ingredient.
Other Name: Testosterone

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717768

Locations
United States, California
Urology Group of Southern California
Los Angeles, California, United States, 90048
Sponsors and Collaborators
TesoRx Pharma, LLC
Investigators
Principal Investigator: John Kowalczyk, DO, FACOS Urology Group of Southern California
  More Information

No publications provided

Responsible Party: TesoRx Pharma, LLC
ClinicalTrials.gov Identifier: NCT01717768     History of Changes
Other Study ID Numbers: TT-002 
Study First Received: October 25, 2012
Results First Received: August 14, 2015
Last Updated: December 14, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by TesoRx Pharma, LLC:
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

Additional relevant MeSH terms:
Hypogonadism
Endocrine System Diseases
Gonadal Disorders
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2016