A Phase 3 interventional study of Testosterone and Testosterone in Male Hypogonadism, sponsored by Acerus Pharmaceuticals Corporation. Completed at 30 sites in United States. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-06-13.
Sponsored by Acerus Pharmaceuticals Corporation · Phase 3, Interventional, and Treatment
The purpose of this study is to determine the efficacy (based on the pharmacokinetic profile of testosterone) and safety of TBS-1 in the treatment of hypogonadal men
This study is a 4 Period study consists of 16 visits with overnight clinic stays that span over year to help determine the efficacy of TBS-1 gel administered twice daily (b.i.d) and three times daily (t.i.d)
In addition, this study will investigate the safety and tolerability of TBS-1 after 90, 180 and 360 days of treatment.
75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.
This study's enrollment of 306 is above the median of 60 across 55 interventional studies indexed under Eunuchism.
Browse Eunuchism studies →Acerus Pharmaceuticals Corporation is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria
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.
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.
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.
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).
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
5.5 mg per nostril of 4.5% TBS-1 BID
Drug: Testosterone
5.5 mg per nostril of 4.5% TBS-1 TID
Drug: Testosterone
Intranasal testosterone
Intranasal testosterone
Serum Testosterone Cavg
The percentage of patients with an average serum total testosterone concentration (Cavg) within the normal range (300 to 1050 ng/dL)
Time frame: 90 days
Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90
To determine the efficacy of 4.5% TBS-1 gel, administered 2 or 3 times daily at a dose of 5.5 mg per nostril, in achieving the following serum total testosterone maximum concentration (Cmax) on Day 90: * A Cmax (maximum testosterone concentration) value of 1500 ng/dL or more in at least 85% of the participants analyzed * A Cmax (maximum testosterone concentration) value of 1800 to 2500 ng/dL in fewer than 5% of participants analyzed * No analyzed participants with a Cmax (maximum testosterone concentration) \>2500 ng/dL
Time frame: 90 days
| Milestone | TBS-1 - b.i.d. | TBS-1 b.i.d./t.i.d | TBS-1 - t.i.d. |
|---|---|---|---|
| Started | 142 | 86 | 78 |
| Completed | 122 | 83 | 69 |
| Not completed | 20 | 3 | 9 |
| Withdrew: Withdrawal by subject | 12 | 2 | 4 |
| Withdrew: Adverse event | 1 | 0 | 4 |
| Withdrew: Lost to follow-up | 5 | 0 | 0 |
| Withdrew: Other reasons | 2 | 1 | 1 |
The percentage of patients with an average serum total testosterone concentration (Cavg) within the normal range (300 to 1050 ng/dL)
| Participants | TBS-1 - b.i.d. | TBS-1 - b.i.d./t.i.d. | TBS-1 - t.i.d. |
|---|---|---|---|
| Serum Testosterone Cavg | 76 | 43 | 61 |
To determine the efficacy of 4.5% TBS-1 gel, administered 2 or 3 times daily at a dose of 5.5 mg per nostril, in achieving the following serum total testosterone maximum concentration (Cmax) on Day 90: * A Cmax (maximum testosterone concentration) value of 1500 ng/dL or more in at least 85% of the participants analyzed * A Cmax (maximum testosterone concentration) value of 1800 to 2500 ng/dL in fewer than 5% of participants analyzed * No analyzed participants with a Cmax (maximum testosterone concentration) \>2500 ng/dL
| Participants | TBS-1 - b.i.d. | TBS-1 - b.i.d./t.i.d. | TBS-1 - t.i.d. |
|---|---|---|---|
| Cmax <=1500 ng/dL | 107 | 77 | 58 |
| 1800 ng/dL <= Cmax <=2500 ng/dL | 6 | 2 | 1 |
| Cmax >2500 ng/dL | 1 | 0 | 0 |
Collected over 1 year. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TBS-1 - b.i.d. | 0/142 (0%) | 2/142 (1.4%) | 65/142 (45.8%) |
| TBS-1 - b.i.d./t.i.d. | 0/86 (0%) | 1/86 (1.2%) | 40/86 (46.5%) |
| TBS-1 - t.i.d. | 1/78 (1.3%) | 2/78 (2.6%) | 46/78 (59%) |
| Event | TBS-1 - b.i.d. | TBS-1 - b.i.d./t.i.d. | TBS-1 - t.i.d. |
|---|---|---|---|
| Internal injuryInjury, poisoning and procedural complications | 0/142 | 0/86 | 1/78 |
| Road traffic accidentInjury, poisoning and procedural complications | 0/142 | 0/86 | 1/78 |
| Abdominal massGastrointestinal disorders | 0/142 | 0/86 | 1/78 |
| Acute Coronary SyndromeCardiac disorders | 0/142 | 1/86 | 0/78 |
| FallInjury, poisoning and procedural complications | 1/142 | 0/86 | 0/78 |
| Hip FractureInjury, poisoning and procedural complications | 1/142 | 0/86 | 0/78 |
| Ligament RaptureInjury, poisoning and procedural complications | 1/142 | 0/86 | 0/78 |
| Event | TBS-1 - b.i.d. | TBS-1 - b.i.d./t.i.d. | TBS-1 - t.i.d. |
|---|---|---|---|
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 8/142 | 8/86 | 3/78 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 6/142 | 5/86 | 3/78 |
| PSA increasedInvestigations | 0/142 | 2/86 | 4/78 |
| ParosmiaNervous system disorders | 7/142 | 3/86 | 2/78 |
| NasopharyngitisInfections and infestations | 4/142 | 4/86 | 3/78 |
| Nasal discomfortRespiratory, thoracic and mediastinal disorders | 6/142 | 2/86 | 3/78 |
| Nasal drynessRespiratory, thoracic and mediastinal disorders | 6/142 | 1/86 | 2/78 |
| BronchitisInfections and infestations | 2/142 | 0/86 | 3/78 |
| Tooth abscessInfections and infestations | 0/142 | 1/86 | 3/78 |
| Upper respiratory tract infectionInfections and infestations | 1/142 | 0/86 | 3/78 |
| Age, Categorical(Participants) | TBS-1 - b.i.d. | TBS-1 - b.i.d./t.i.d. | TBS-1 - t.i.d. | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 121 | 64 | 61 | 246 |
| >=65 years | 21 | 22 | 17 | 60 |
| Sex: Female, Male(Participants) | TBS-1 - b.i.d. | TBS-1 - b.i.d./t.i.d. | TBS-1 - t.i.d. | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 142 | 86 | 78 | 306 |
| Region of Enrollment(Participants) | TBS-1 - b.i.d. | TBS-1 - b.i.d./t.i.d. | TBS-1 - t.i.d. | Total |
|---|---|---|---|---|
| United States | 142 | 86 | 78 | 306 |
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Testosterone
Acerus Pharmaceuticals Corporation