HypogonadismPhase 2NCT01717768

Oral Testosterone for the Treatment of Hypogonadism

A Phase 2 study testing TSX-002 in people with Hypogonadism, run by TesoRx Pharma, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Hypogonadism
What is being tested?: TSX-002
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 1 siteUnited States
Study dates: Oct 2012to Dec 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

Urology Group of Southern California
Los Angeles, California, 90048

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-blind, Dose Response Study of Oral Testosterone in Subjects With Hypogonadism

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: Hypogonadism
Being tested: TSX-002
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
Medical subject headings: Hypogonadism, Gonadal Disorders, Endocrine System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TSX-002Drug
Also called Testosterone
TSX-002 are capsules with testosterone as the active ingredient.

Study groups in NCT01717768
Study group	Role	What they receive
Part 1: 120 mg BID	Experimental	Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days Receives: Drug: TSX-002
Part 1: 240 mg BID	Experimental	Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days Receives: Drug: TSX-002
Part 2: 120 mg BID	Experimental	Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days Receives: Drug: TSX-002
Part 3: A-B-C 120 mg QD	Experimental	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. Receives: Drug: TSX-002
Part 3: B-C-A 120 mg QD	Experimental	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. Receives: Drug: TSX-002
Part 3: C-A-B 120 mg QD	Experimental	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. Receives: Drug: TSX-002
Part 4 Cohort 1: 60 mg BID/ 60 mg TID	Experimental	Oral TSX-002 60 mg BID for 15 days then 60 mg TID for 15 days Receives: Drug: TSX-002
Part 4 Cohort 2: 90 mg BID/ 90 mg TID	Experimental	Oral TSX-002 90 mg BID for 15 days then 90 mg TID for 15 days Receives: Drug: TSX-002
Part 4 Cohort 3: 180 mg QD	Experimental	Oral TSX-002 180 mg once daily (QD) for 15 days Receives: Drug: TSX-002
Part 4 Cohort 4: 120 mg BID	Experimental	Oral TSX-002 120 mg BID for 15 days Receives: Drug: TSX-002

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 15 days

Secondary outcomes (1)

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.
Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Dec 2014

First posted30 Oct 2012 (estimated)
Study startOct 2012
Primary completionAug 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypogonadismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01717768
Sponsor's protocol ID: TT-002
Status last verified: Dec 2015
First submitted: 25 Oct 2012
Last updated: 15 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
Hypogonadism, Male, Endocrine Disease
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
RecruitingPhase 4
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Prostate Cancer, Hypogonadism, Male
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship

All Hypogonadism trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-blind, Dose Response Study of Oral Testosterone in Subjects With Hypogonadism
ClinicalTrials.gov ID: NCT01717768
Acronym / sponsor ID: TT-002
Conditions: Hypogonadism
Keywords: hypogonadism, Gonadal Disorders, Endocrine System Diseases, Testosterone, Testosterone enanthate, Testosterone undecanoate, Testosterone 17 beta-cypionate, Methyltestosterone
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: TesoRx Pharma, LLCIndustry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Aug 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 30 Oct 2012 (estimated)
Results: Posted 15 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 10

Arm	Type	Receives
Part 1: 120 mg BID	Experimental	Drug: TSX-002Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
Part 1: 240 mg BID	Experimental	Drug: TSX-002Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days
Part 2: 120 mg BID	Experimental	Drug: TSX-002Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
Part 3: A-B-C 120 mg QD	Experimental	Drug: TSX-002Open-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.
Part 3: B-C-A 120 mg QD	Experimental	Drug: TSX-002Open-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.
Part 3: C-A-B 120 mg QD	Experimental	Drug: TSX-002Open-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.
Part 4 Cohort 1: 60 mg BID/ 60 mg TID	Experimental	Drug: TSX-002Oral TSX-002 60 mg BID for 15 days then 60 mg TID for 15 days
Part 4 Cohort 2: 90 mg BID/ 90 mg TID	Experimental	Drug: TSX-002Oral TSX-002 90 mg BID for 15 days then 90 mg TID for 15 days
Part 4 Cohort 3: 180 mg QD	Experimental	Drug: TSX-002Oral TSX-002 180 mg once daily (QD) for 15 days
Part 4 Cohort 4: 120 mg BID	Experimental	Drug: TSX-002Oral TSX-002 120 mg BID for 15 days

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TSX-002Also: TestosteroneTSX-002 are capsules with testosterone as the active ingredient.	Drug	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

Primary outcome

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
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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 15 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: 120 mg BID	17	17
Part 1: 240 mg BID	17	16
Part 2: 120 mg BID	0	0
Part 3: A-B-C 120 mg QD	0	0
Part 3: B-C-A 120 mg QD	0	0
Part 3: C-A-B 120 mg QD	0	0
Part 4 Cohort 1: 60 mg BID	0	0
Part 4 Cohort 1: 60 mg TID	0	0
Part 4 Cohort 2: 90 mg BID	0	0
Part 4 Cohort 2: 90 mg TID	0	0
Part 4 Cohort 3: 180 mg QD	0	0
Part 4 Cohort 4: 120 mg BID	0	0

Primary outcome: 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. Number. Unit: percentage of participants

Measure	Part 1: 120 mg BID n = 17	Part 1: 240 mg BID n = 17	Part 2: 120 mg BID n = 17	Part 4 Cohort 1: 60 mg BID n = 17	Part 4 Cohort 1: 60 mg TID n = 17	Part 4 Cohort 2: 90 mg BID n = 16	Part 4 Cohort 2: 90 mg TID n = 16	Part 4 Cohort 3: 180 mg QD n = 16	Part 4 Cohort 4: 120 mg BID n = 16
Value	59	31	35	41	53	19	20	31	27

Population analysed: All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: 120 mg BID	0 of 17 (0%)	6 of 17 (35.3%)	Not reported
Part 1: 240 mg BID	0 of 17 (0%)	8 of 17 (47.1%)	Not reported
Part 2: 120 mg BID	0 of 17 (0%)	6 of 17 (35.3%)	Not reported
Part 3: A-B-C 120 mg QD	0 of 4 (0%)	0 of 4 (0%)	Not reported
Part 3: B-C-A 120 mg QD	0 of 5 (0%)	2 of 5 (40%)	Not reported
Part 3: C-A-B 120 mg QD	0 of 5 (0%)	2 of 5 (40%)	Not reported
Part 4 Cohort 1: 60 mg BID	0 of 17 (0%)	3 of 17 (17.6%)	Not reported
Part 4 Cohort 1: 60 mg TID	0 of 17 (0%)	3 of 17 (17.6%)	Not reported
Part 4 Cohort 2: 90 mg BID	0 of 16 (0%)	0 of 16 (0%)	Not reported
Part 4 Cohort 2: 90 mg TID	0 of 16 (0%)	2 of 16 (12.5%)	Not reported
Part 4 Cohort 3: 180 mg QD	0 of 16 (0%)	6 of 16 (37.5%)	Not reported
Part 4 Cohort 4: 120 mg BID	0 of 16 (0%)	3 of 16 (18.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypogonadism

RecruitingObservational study
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Kowalczyk, DO, FACOS principal investigator

Urology Group of Southern California

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TSX-002 in people with Hypogonadism, run by TesoRx Pharma, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01717768.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2015.