CompletedNCT02222558Updated May 30, 2016Results posted

Oral Testosterone for the Treatment of Hypogonadism in Males

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 to 70 Years. Per ClinicalTrials.gov, last updated 2016-05-30.

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

Phase: Phase 2
Study type: Interventional
Enrollment: 25
Allocation: Randomized
Ages: 18 Years to 70 Years
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.

Read the detailed description

The purpose of this study is to evaluate the pharmacokinetic (PK) parameters of testosterone after administration of TSX-002 (easy to swallow testosterone capsules) to hypogonadal men. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the PK parameters of the testosterone metabolite, dihydrotestosterone (DHT), as well as the safety and tolerability of TSX-002. The study consists of three (3) periods, for which TSX-002 will be taken orally at various doses. Study duration is approximately 9 weeks.

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,
Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anabolic Agents
dihydrotestosterone

In context

Hypogonadism

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

This study's enrollment of 25 is below 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 to 70 Years
Sexes eligible: Male
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Symptomatic hypogonadal male subjects (Testosterone > 100 and \<300 ng/dL, two separate 10 am samples one week apart),
18-70 years old,
Willing and able to provide and to participate in all 3 periods of the study.
\< 35 kg/m2.

Exclusion criteria

Exclusion Criteria:

Malabsorption conditions (e.g. history of cholecystectomy, Inflammatory Bowel Disease, Pancreatitis, Celiac disease, Sprue, Dumping syndrome, Bariatric surgery; Short bowel syndrome, Lactose intolerance);
Alcoholics or substance abuse;
Gastroparesis; IPSS (International Prostate Symptom score) > 19; PSA (prostate-specific antigen)> 4 ng/ml;
Congestive Heart Failure, uncontrolled (NYHC >1);
Uncontrolled sleep apnea;
Topical or injectable testosterone replacement therapy (any kind including dehydroepiandrosterone (DHEA) and nutritional supplements) within past 4 weeks;
Testopel excluded if within 2 years;
Aveed excluded if within past 6 months;
Hematocrit > 50.

Terms in these criteria, in plain language(2)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 25 participants (actual)

Study arms

Experimental
Period 1: Single Dose
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.
Drug: TSX-002
Experimental
Period 2: Two Times Daily Dosing 90 mg
Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
Drug: TSX-002
Experimental
Period 3: Two Times Daily Dosing 120 mg
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.
Drug: TSX-002
Experimental
Period 3: Three Times Daily Dosing 90 mg
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.
Drug: TSX-002
Experimental
Period 3: Two Times Daily Dosing 180 mg
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.
Drug: TSX-002
Experimental
Period 3: Three Times Daily Dosing 120 mg
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.
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 Responders
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

Results

Posted May 30, 2016

Participant flow

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.

Period 1: Single Dose

Participant flow — Period 1: Single Dose
Milestone	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
Started	25	0	0	0	0	0
Completed	21	0	0	0	0	0
Not completed	4	0	0	0	0	0
Withdrew: Withdrawal by subject	4	0	0	0	0	0

Period 2: Two Times Daily Dosing 90 mg

Participant flow — Period 2: Two Times Daily Dosing 90 mg
Milestone	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
Started	0	21	0	0	0	0
Completed	0	21	0	0	0	0
Not completed	0	0	0	0	0	0

Period 3

Participant flow — Period 3
Milestone	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
Started	4	1	8	8
Completed	4	1	8	7
Not completed	0	0	0	1
Withdrew: Withdrawal by subject	0	0	0	1

Outcome measures

PrimaryPercentage of Responders

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
Reported as:: Number · percentage of subjects

Percentage of Responders
percentage of subjects	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
Percentage of Responders	67	57	50	100	25	57.1

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Period 1: Single Dose	—	0/25 (0%)	5/25 (20%)
Period 2: Two Times Daily Dosing 90 mg	—	0/21 (0%)	7/21 (33.3%)
Period 3: Two Times Daily Dosing 120 mg	—	0/4 (0%)	1/4 (25%)
Period 3: Three Times Daily Dosing 90 mg	—	0/1 (0%)	1/1 (100%)
Period 3: Two Times Daily Dosing 180 mg	—	1/8 (12.5%)	2/8 (25%)
Period 3: Three Times Daily Dosing 120 mg	—	0/8 (0%)	2/8 (25%)

Most frequent serious events

Most frequent serious events
Event	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
RhabdomyolysisMusculoskeletal and connective tissue disorders	0/25	0/21	0/4	0/1	1/8	0/8

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	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
HeadacheNervous system disorders	5/25	4/21	0/4	1/1	1/8	1/8
Testicular painReproductive system and breast disorders	0/25	0/21	0/4	1/1	0/8	0/8
Oedema PeripheralGeneral disorders	0/25	0/21	1/4	0/1	0/8	0/8
RhinitisInfections and infestations	0/25	3/21	0/4	0/1	0/8	0/8
Prostatic specific antigen increasedInvestigations	0/25	0/21	0/4	0/1	1/8	1/8
Blood creatine phosphokinase increasedInvestigations	0/25	0/21	0/4	0/1	1/8	0/8
Blood potassium increasedInvestigations	0/25	0/21	0/4	0/1	1/8	0/8
HyperkalaemiaMetabolism and nutrition disorders	0/25	0/21	0/4	0/1	1/8	0/8
RhabdomyolysisMusculoskeletal and connective tissue disorders	0/25	0/21	0/4	0/1	1/8	0/8
HypoaesthesiaNervous system disorders	0/25	0/21	0/4	0/1	1/8	0/8

Baseline characteristics

Subjects that began each defined period.

Age, Categorical
Age, Categorical(Participants)	All Study Participants
<=18 years	0
Between 18 and 65 years	22
>=65 years	3

Age, Continuous
Age, Continuous(years)	All Study Participants
Mean	54.4 (31 to 70)

Sex: Female, Male
Sex: Female, Male(Participants)	All Study Participants
Female	0
Male	25

Region of Enrollment
Region of Enrollment(participants)	All Study Participants
United States	25

Study locations

1 site

San Diego Sexual Medicine
San Diego, California 92120, United States

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2014, a primary completion of Apr 2015 and a completion of May 2015. It does not say whether these dates are actual or estimated.

Results were first posted in May 2016, 1 year 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 18, 2014
First posted: Aug 21, 2014
Start: Sep 2014
Primary completionActual: Apr 2015
CompletionActual: May 2015
Results first posted: May 30, 2016
Last update: May 30, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02222558
Lead sponsor: TesoRx Pharma, LLC
Responsible party: Sponsor
First posted: Aug 21, 2014
Start date: Sep 2014
Primary completion: Apr 2015
Completion: May 2015
Results posted: May 30, 2016
Last update: May 30, 2016

Study contacts

Irwin Goldstein, MD

principal investigator · San Diego Sexual Medicine

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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