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Trial record 22 of 213 for:    "Hypogonadism" | "Androgens"

Oral Testosterone for the Treatment of Hypogonadism in Males

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ClinicalTrials.gov Identifier: NCT02222558
Recruitment Status : Completed
First Posted : August 21, 2014
Results First Posted : May 30, 2016
Last Update Posted : May 30, 2016
Sponsor:
Information provided by (Responsible Party):
TesoRx Pharma, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypogonadism
Intervention Drug: TSX-002
Enrollment 25
Recruitment Details The planned enrollment for this study was up to 28 subjects. The actual enrollment of the study was 25 subjects, all of whom were included in the safety and PK evaluable populations. This was a single-center study conducted at San Diego Sexual Medicine medical clinic. First patient screened 27Aug2014, FPE 05Sep2014, LPE 28Jan2015, LPLV 24Apr2015.
Pre-assignment Details Period 1: Each study subject received 5 escalating single doses of TSX-002. Period 2: Each study subject dose was 90 mg BID of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level was drawn and used to determine eligibility for randomization to a further treatment group (BID vs. TID) or continuation in a BID treatment regimen.
Arm/Group Title Period 1: Single Dose Period 2: Two Times Daily Dosing 90 mg Period 3: Two Times Daily Dosing 120 mg Period 3: Three Times Daily Dosing 90 mg Period 3: Two Times Daily Dosing 180 mg Period 3: Three Times Daily Dosing 120 mg
Hide Arm/Group Description Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2. Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.

Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.

Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.

Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.

Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.

Period Title: Period 1: Single Dose
Started 25 0 0 0 0 0
Completed 21 0 0 0 0 0
Not Completed 4 0 0 0 0 0
Reason Not Completed
Withdrawal by Subject             4             0             0             0             0             0
Period Title: Period 2: Two Times Daily Dosing 90 mg
Started 0 21 0 0 0 0
Completed 0 21 0 0 0 0
Not Completed 0 0 0 0 0 0
Period Title: Period 3
Started 0 0 4 1 8 8
Completed 0 0 4 1 8 7
Not Completed 0 0 0 0 0 1
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             1
Arm/Group Title All Study Participants
Hide Arm/Group Description

Study participants start in Period 1 and proceed to Period 2 and then Period 3 Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.

Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.

Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
Subjects that began each defined period.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
22
  88.0%
>=65 years
3
  12.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants
54.4
(31 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
0
   0.0%
Male
25
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
1.Primary Outcome
Title Percentage of Responders
Hide Description Percentage of subjects with response to treatment within each period. Response to treatment was considered when Testosterone Cavg was within the physiological range of Testosterone concentration, i.e. 300 - 1050 ng/dL.
Time Frame Cavg from samples at Period 1: post dose hrs 0,1,2,3,4,5,6,8,12,16,24; Period 2: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 BID: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 TID: hrs 0,2,3,4,5,6,8,10,11,12,13,14,16,18,19,20,21,22,24
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received TSX-002 and provided PK concentrations for the protocol required 24 hour collection periods.
Arm/Group Title Period 1: Single Dose Period 2: Two Times Daily Dosing 90 mg Period 3: Two Times Daily Dosing 120 mg Period 3: Three Times Daily Dosing 90 mg Period 3: Two Times Daily Dosing 180 mg Period 3: Three Times Daily Dosing 120 mg
Hide Arm/Group Description:
Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.

Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.

Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.

Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.

Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.

Overall Number of Participants Analyzed 25 21 4 1 8 7
Measure Type: Number
Unit of Measure: percentage of subjects
67 57 50 100 25 57.1
Time Frame 17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
Adverse Event Reporting Description

An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question “How have you been feeling since you were last asked?” at all visits from Day 0 to Exit.

Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).

 
Arm/Group Title Period 1: Single Dose Period 2: Two Times Daily Dosing 90 mg Period 3: Two Times Daily Dosing 120 mg Period 3: Three Times Daily Dosing 90 mg Period 3: Two Times Daily Dosing 180 mg Period 3: Three Times Daily Dosing 120 mg
Hide Arm/Group Description Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2. Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.

Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.

Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.

Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.

Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.

All-Cause Mortality
Period 1: Single Dose Period 2: Two Times Daily Dosing 90 mg Period 3: Two Times Daily Dosing 120 mg Period 3: Three Times Daily Dosing 90 mg Period 3: Two Times Daily Dosing 180 mg Period 3: Three Times Daily Dosing 120 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Period 1: Single Dose Period 2: Two Times Daily Dosing 90 mg Period 3: Two Times Daily Dosing 120 mg Period 3: Three Times Daily Dosing 90 mg Period 3: Two Times Daily Dosing 180 mg Period 3: Three Times Daily Dosing 120 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/21 (0.00%)      0/4 (0.00%)      0/1 (0.00%)      1/8 (12.50%)      0/8 (0.00%)    
Musculoskeletal and connective tissue disorders             
Rhabdomyolysis  1 [1]  0/25 (0.00%)  0 0/21 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
[1]
Unrelated to study drug, due to muscle injury due to prolonged muscle compression. Lab abnormalities included acute renal failure secondary to rhabdomyolysis, hyperkalemia, high creatinine kinase, and high level of potassium.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Period 1: Single Dose Period 2: Two Times Daily Dosing 90 mg Period 3: Two Times Daily Dosing 120 mg Period 3: Three Times Daily Dosing 90 mg Period 3: Two Times Daily Dosing 180 mg Period 3: Three Times Daily Dosing 120 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/25 (20.00%)      7/21 (33.33%)      1/4 (25.00%)      1/1 (100.00%)      2/8 (25.00%)      2/8 (25.00%)    
General disorders             
Oedema Peripheral  1  0/25 (0.00%)  0 0/21 (0.00%)  0 1/4 (25.00%)  2 0/1 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Infections and infestations             
Nasopharyngitis  1  0/25 (0.00%)  0 2/21 (9.52%)  2 0/4 (0.00%)  0 0/1 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Rhinitis  1  0/25 (0.00%)  0 3/21 (14.29%)  3 0/4 (0.00%)  0 0/1 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Investigations             
Prostatic specific antigen increased  1  0/25 (0.00%)  0 0/21 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 1/8 (12.50%)  1 1/8 (12.50%)  1
Blood creatine phosphokinase increased  1  0/25 (0.00%)  0 0/21 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Blood potassium increased  1  0/25 (0.00%)  0 0/21 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Metabolism and nutrition disorders             
Hyperkalaemia  1  0/25 (0.00%)  0 0/21 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Rhabdomyolysis  1  0/25 (0.00%)  0 0/21 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Nervous system disorders             
Headache  1  5/25 (20.00%)  7 4/21 (19.05%)  4 0/4 (0.00%)  0 1/1 (100.00%)  1 1/8 (12.50%)  1 1/8 (12.50%)  1
Hypoaesthesia  1  0/25 (0.00%)  0 0/21 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Renal and urinary disorders             
Renal failure acute  1  0/25 (0.00%)  0 0/21 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Reproductive system and breast disorders             
Testicular pain  1  0/25 (0.00%)  0 0/21 (0.00%)  0 0/4 (0.00%)  0 1/1 (100.00%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
At 60 days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy and allow Sponsor 60 days to review and comment and provide written permission prior to publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Oefelein, MD, Chief Medical Officer
Organization: TesoRx Pharma, LLC
Phone: 909-595-0500 ext 104
EMail: karl@tesorx.com
Layout table for additonal information
Responsible Party: TesoRx Pharma, LLC
ClinicalTrials.gov Identifier: NCT02222558     History of Changes
Other Study ID Numbers: TT-006
First Submitted: August 18, 2014
First Posted: August 21, 2014
Results First Submitted: March 16, 2016
Results First Posted: May 30, 2016
Last Update Posted: May 30, 2016