CompletedNCT01717768Updated Dec 15, 2015Results posted

Oral Testosterone for the Treatment of Hypogonadism

A Phase 2 interventional study of TSX-002 in Hypogonadism, sponsored by TesoRx Pharma, LLC. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-15.

Sponsored by TesoRx Pharma, LLC · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 130
Allocation: Randomized
Ages: 18 Years and older
Sex: Male

Study summary

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.

Conditions studied

Hypogonadism

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Keywords

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

In context

Hypogonadism

320 studies on the registry are indexed under Hypogonadism; 39 are open to participants now.

This study's enrollment of 130 is above the median of 50 across 243 interventional studies indexed under Hypogonadism.

Browse Hypogonadism studies →

Lead sponsor

TesoRx Pharma, LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No

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 (BMI) \< 39.0 kg/m2 and weighing ≥ 55 kg
levels at screening and baseline > 12.5 g/dL
Testosterone treatment not
No evidence of suspected reversible hypogonadism
Willing to abstain from current treatment for hypogonadism in accordance with approved labeling to facilitate an appropriate 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

Exclusion Criteria:

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 130 participants (actual)

Study arms

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
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
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
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
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
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
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
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
Experimental
Part 4 Cohort 3: 180 mg QD
Oral TSX-002 180 mg once daily (QD) for 15 days
Drug: TSX-002
Experimental
Part 4 Cohort 4: 120 mg BID
Oral TSX-002 120 mg BID for 15 days
Drug: TSX-002

Interventions

DrugTSX-002
TSX-002 are capsules with testosterone as the active ingredient.
Also known as: Testosterone

What researchers measure

Primary outcomes

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
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.
Time frame: 15 days

Secondary outcomes

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
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.
Time frame: 15 days

Other outcomes

Cavg 0-24 Hrs (ng/dL) After 120 mg Dose
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.
Time frame: 24 hrs
AUC 0-24 Hrs After 120 mg Dose of TSX-002
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.
Time frame: 24 hrs

Results

Posted Dec 15, 2015

Participant flow

130 subjects were recruited at 1 center in the US from October 2012 to May 2014. The study was designed with 4 parts, including 9 different dosages of the investigational drug.

Part 1 (Duration of 15 Days)

Participant flow — Part 1 (Duration of 15 Days)
Milestone	Part 1: 120 mg BID	Part 1: 240 mg BID
Started	17	17
Completed	17	16
Not completed	0	1
Withdrew: Lost to follow-up	0	1

Part 2 (Duration of 15 Days)

Participant flow — Part 2 (Duration of 15 Days)
Milestone	Part 1: 120 mg BID	Part 1: 240 mg BID	Part 2: 120 mg BID	Part 3: A-B-C 120 mg QD	Part 3: B-C-A 120 mg QD	Part 3: C-A-B 120 mg QD	Part 4 Cohort 1: 60 mg BID	Part 4 Cohort 1: 60 mg TID	Part 4 Cohort 2: 90 mg BID	Part 4 Cohort 2: 90 mg TID	Part 4 Cohort 3: 180 mg QD	Part 4 Cohort 4: 120 mg BID
Started	0	0	17	0	0	0	0	0	0	0	0	0
Completed	0	0	17	0	0	0	0	0	0	0	0	0
Not completed	0	0	0	0	0	0	0	0	0	0	0	0

Part 3 - Treatment 1 (Duration of 1 Day)

Participant flow — Part 3 - Treatment 1 (Duration of 1 Day)
Milestone	Part 3: A-B-C 120 mg QD	Part 3: B-C-A 120 mg QD	Part 3: C-A-B 120 mg QD
Started	4	5	5
Completed	4	5	5
Not completed	0	0	0

Part 3 - Treatment 2 (Duration of 1 Day)

Participant flow — Part 3 - Treatment 2 (Duration of 1 Day)
Milestone	Part 3: A-B-C 120 mg QD	Part 3: B-C-A 120 mg QD	Part 3: C-A-B 120 mg QD
Started	4	5	5
Completed	4	5	5
Not completed	0	0	0

Part 3 - Treatment 3 (Duration of 1 Day)

Participant flow — Part 3 - Treatment 3 (Duration of 1 Day)
Milestone	Part 3: A-B-C 120 mg QD	Part 3: B-C-A 120 mg QD	Part 3: C-A-B 120 mg QD
Started	4	5	5
Completed	4	5	5
Not completed	0	0	0

Part 4-Treatment 1 (Duration of 15 Days)

Participant flow — Part 4-Treatment 1 (Duration of 15 Days)
Milestone	Part 4 Cohort 1: 60 mg BID	Part 4 Cohort 2: 90 mg BID	Part 4 Cohort 3: 180 mg QD	Part 4 Cohort 4: 120 mg BID
Started	17	16	16	16
Completed	17	16	16	15
Not completed	0	0	0	1
Withdrew: Protocol violation	0	0	0	1

Part 4-Treatment 2 (Duration of 15 Days)

Participant flow — Part 4-Treatment 2 (Duration of 15 Days)
Milestone	Part 4 Cohort 1: 60 mg TID	Part 4 Cohort 2: 90 mg TID
Started	17	16
Completed	15	15
Not completed	2	1
Withdrew: Withdrawal by subject	2	0
Withdrew: Lost to follow-up	0	1

Outcome measures

PrimaryPercentage 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

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.

Time frame:: 15 days
Reported as:: Number · percentage of participants

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
percentage of participants	Part 1: 120 mg BID	Part 1: 240 mg BID	Part 2: 120 mg BID	Part 4 Cohort 1: 60 mg BID	Part 4 Cohort 1: 60 mg TID	Part 4 Cohort 2: 90 mg BID	Part 4 Cohort 2: 90 mg TID	Part 4 Cohort 3: 180 mg QD	Part 4 Cohort 4: 120 mg BID
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	59	31	35	41	53	19	20	31	27

SecondaryPercentage 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

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.

Time frame:: 15 days
Reported as:: Number · percentage of subjects

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
percentage of subjects	Part 1: 120 mg BID	Part 1: 240 mg BID	Part 2: 120 mg BID	Part 4 Cohort 1: 60 mg BID	Part 4 Cohort 1: 60 mg TID	Part 4 Cohort 2: 90 mg BID	Part 4 Cohort 2: 90 mg TID	Part 4 Cohort 3: 180 mg QD	Part 4 Cohort 4: 120 mg BID
Percentage of subjects with Cmax ≤ 1500 ng/dL afte	100	100	94.1	100	100	100	100	100	93.75
Percentage of subjects with Cmax ≥ 1800 and ≤ 2500	0	0	0	0	0	0	0	0	6.25
Percentage of subjects with Cmax > 2500 ng/dL afte	0	0	0	0	0	0	0	0	0

Other pre-specifiedCavg 0-24 Hrs (ng/dL) After 120 mg Dose

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.

Time frame:: 24 hrs
Reported as:: Least squares mean · ng/dL

Cavg 0-24 Hrs (ng/dL) After 120 mg Dose
ng/dL	Part 3:120 mg QD Treatment A	Part 3:120 mg QD Treatment B	Part 3:120 mg QD Treatment C
Cavg 0-24 Hrs (ng/dL) After 120 mg Dose	296 ± 108	297 ± 75	273 ± 109

Other pre-specifiedAUC 0-24 Hrs After 120 mg Dose of TSX-002

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.

Time frame:: 24 hrs
Reported as:: Median · hr×ng/dL

AUC 0-24 Hrs After 120 mg Dose of TSX-002
hr×ng/dL	Part 3:120 mg QD Treatment A	Part 3:120 mg QD Treatment B	Part 3:120 mg QD Treatment C
AUC 0-24 Hrs After 120 mg Dose of TSX-002	1941 ± 1198	2117 ± 1351	1516 ± 1217

Adverse events

Collected over The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part 1: 120 mg BID	—	0/17 (0%)	6/17 (35.3%)
Part 1: 240 mg BID	—	0/17 (0%)	8/17 (47.1%)
Part 2: 120 mg BID	—	0/17 (0%)	6/17 (35.3%)
Part 3: A-B-C 120 mg QD	—	0/4 (0%)	0/4 (0%)
Part 3: B-C-A 120 mg QD	—	0/5 (0%)	2/5 (40%)
Part 3: C-A-B 120 mg QD	—	0/5 (0%)	2/5 (40%)
Part 4 Cohort 1: 60 mg BID	—	0/17 (0%)	3/17 (17.6%)
Part 4 Cohort 1: 60 mg TID	—	0/17 (0%)	3/17 (17.6%)
Part 4 Cohort 2: 90 mg BID	—	0/16 (0%)	0/16 (0%)
Part 4 Cohort 2: 90 mg TID	—	0/16 (0%)	2/16 (12.5%)
Part 4 Cohort 3: 180 mg QD	—	0/16 (0%)	6/16 (37.5%)
Part 4 Cohort 4: 120 mg BID	—	0/16 (0%)	3/16 (18.8%)

Most frequent other events

Showing 10 of 45

Most frequent other events
Event	Part 1: 120 mg BID	Part 1: 240 mg BID	Part 2: 120 mg BID	Part 3: A-B-C 120 mg QD	Part 3: B-C-A 120 mg QD	Part 3: C-A-B 120 mg QD	Part 4 Cohort 1: 60 mg BID	Part 4 Cohort 1: 60 mg TID	Part 4 Cohort 2: 90 mg BID	Part 4 Cohort 2: 90 mg TID	Part 4 Cohort 3: 180 mg QD	Part 4 Cohort 4: 120 mg BID
Oral painGastrointestinal disorders	0/17	0/17	0/17	0/4	1/5	0/5	0/17	0/17	0/16	0/16	0/16	0/16
Infusion site extravasationGeneral disorders	0/17	0/17	0/17	0/4	1/5	0/5	0/17	0/17	0/16	0/16	0/16	0/16
LacerationInjury, poisoning and procedural complications	0/17	0/17	0/17	0/4	0/5	1/5	0/17	0/17	0/16	0/16	0/16	0/16
Blood potassium increasedInvestigations	0/17	0/17	0/17	0/4	0/5	1/5	0/17	0/17	0/16	0/16	0/16	0/16
HeadacheNervous system disorders	0/17	2/17	1/17	0/4	0/5	0/5	1/17	0/17	0/16	0/16	2/16	1/16
DiarrhoeaGastrointestinal disorders	1/17	1/17	1/17	0/4	0/5	0/5	1/17	0/17	0/16	0/16	0/16	1/16
FlatulenceGastrointestinal disorders	0/17	0/17	0/17	0/4	0/5	0/5	0/17	0/17	0/16	0/16	0/16	1/16
Gastrooesophageal reflux diseaseGastrointestinal disorders	0/17	0/17	0/17	0/4	0/5	0/5	0/17	0/17	0/16	0/16	0/16	1/16
Catheter site phlebitisGeneral disorders	0/17	0/17	0/17	0/4	0/5	0/5	0/17	0/17	0/16	1/16	0/16	0/16
FatigueGeneral disorders	0/17	0/17	0/17	0/4	0/5	0/5	0/17	0/17	0/16	0/16	1/16	0/16

Baseline characteristics

Age, Customized
Age, Customized(participants)	Part 1: 120 mg BID	Part 1: 240 mg BID	Part 2: 120 mg BID	Part 3: A-B-C 120 mg QD	Part 3: B-C-A 120 mg QD	Part 3: C-A-B 120 mg QD	Part 4 Cohort 1: 60 mg BID/ 60 mg TID	Part 4 Cohort 2: 90 mg BID/ 90 mg TID	Part 4 Cohort 3: 180 mg QD	Part 4 Cohort 4: 120 mg BID	Total
<50 years	2	4	8	1	1	0	4	4	9	5	38
50-64 years	11	11	5	1	4	4	9	8	7	9	69
65-74 years	3	2	3	1	0	1	3	4	0	2	19
75 years or older	1	0	1	1	0	0	1	0	0	0	4

Sex/Gender, Customized
Sex/Gender, Customized(participants)	Part 1: 120 mg BID	Part 1: 240 mg BID	Part 2: 120 mg BID	Part 3: A-B-C 120 mg QD	Part 3: B-C-A 120 mg QD	Part 3: C-A-B 120 mg QD	Part 4 Cohort 1: 60 mg BID/ 60 mg TID	Part 4 Cohort 2: 90 mg BID/ 90 mg TID	Part 4 Cohort 3: 180 mg QD	Part 4 Cohort 4: 120 mg BID	Total
Male	17	17	17	4	5	5	17	16	16	16	130

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Part 1: 120 mg BID	Part 1: 240 mg BID	Part 2: 120 mg BID	Part 3: A-B-C 120 mg QD	Part 3: B-C-A 120 mg QD	Part 3: C-A-B 120 mg QD	Part 4 Cohort 1: 60 mg BID/ 60 mg TID	Part 4 Cohort 2: 90 mg BID/ 90 mg TID	Part 4 Cohort 3: 180 mg QD	Part 4 Cohort 4: 120 mg BID	Total
American Indian or Alaska Native	0	0	0	0	0	0	1	0	0	1	2
Asian	0	0	0	0	0	0	1	0	0	1	2
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	1	0	0	1	2
Black or African American	3	5	0	1	3	3	4	4	3	1	27
White	13	12	17	3	2	2	10	12	13	12	96
More than one race	1	0	0	0	0	0	0	0	0	0	1
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Part 1: 120 mg BID	Part 1: 240 mg BID	Part 2: 120 mg BID	Part 3: A-B-C 120 mg QD	Part 3: B-C-A 120 mg QD	Part 3: C-A-B 120 mg QD	Part 4 Cohort 1: 60 mg BID/ 60 mg TID	Part 4 Cohort 2: 90 mg BID/ 90 mg TID	Part 4 Cohort 3: 180 mg QD	Part 4 Cohort 4: 120 mg BID	Total
United States	17	17	17	4	5	5	17	16	16	16	130

Study locations

1 site

Urology Group of Southern California
Los Angeles, California 90048, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01717768
Lead sponsor: TesoRx Pharma, LLC
Responsible party: Sponsor
First posted: Oct 30, 2012
Start date: Oct 2012
Primary completion: Aug 2014
Completion: Dec 2014
Results posted: Dec 15, 2015
Last update: Dec 15, 2015

Study contacts

John Kowalczyk, DO, FACOS

principal investigator · Urology Group of Southern California

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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