A Phase 4 interventional study of Andriol Testocaps in Assess the Effects of a the 90-day Oral TS Study Regimen on PSA, IPSS, Haemoglobin and Haematocrit, and to Assess Adverse and Serious Adverse Events., sponsored by Singapore Clinical Research Institute. Terminated at 12 sites in Singapore. Open to male participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-01-06.
Sponsored by Singapore Clinical Research Institute · Phase 4, Interventional, and Supportive care
The study hypothesis is that treatment with oral Testosterone according to the study regimen will improve glycemic control in T2DM Chinese males in Singapore as indicated by a reduction in HbA1c levels at study day 90.
This is a single arm open label clinical study in Chinese men of 45 to 75 years of age with Type 2 Diabetes. Subjects will be recruited from participating family medicine clinics with the FMRN and followed for 90-days. All subjects will continue on pre-study treatment regimens and medications as clinically indicated throughout the 90-day study period. Missed doses of study drug can be made up within the same day. With the exceptions of study drug and diabetic medications, changes in other medications will be permitted. The primary aim is to assess the effects of oral Testosterone on change in HbA1c levels in the Chinese males with a diagnosis of T2DM over a 90-day study period.
Subjects enrolled in the study will take two 40mg capsules of oral testosterone in the morning and two 40mg capsules in the evening with meals on both occasions on each day. This daily dosage is consistent with the recommended dosage for subjects being treated for hypogonadism.
Primary objective:
Secondary objectives:
All subjects must satisfy ALL of the following criteria at study entry:
All subjects must NOT have any of the following criteria at study entry:
Blood samples will be drawn during the study period:
Singapore Clinical Research Institute 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.
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.
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).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
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.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
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.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
90 day oral testosterone therapy
Drug: Andriol Testocaps
Oral, 40mg, Twice a day, 30days
The Effect of 90-day Oral Testosterone Therapy in Chinese Males with Type 2 Diabetes (T2DM): OTeST
The primary aim is to assess the effect of oral Testosterone Supplementation on percent change in HbA1c in Type 2 Diabetes Mellitus Chinese males in Singapore over a 90-day study period.
Time frame: 90 Day Study Period
The Effect of 90-day Oral Testosterone Therapy in Chinese Males with Type 2 Diabetes (T2DM): OTeST
The secondary aim is to assess the effects of site, eugonadism and hypogonadism, and the prognostic relevance of baseline levels of HbA1c, total testosterone, PSA, IPSS, haemoglobin and haematocrit on 90-day change and percent change from baseline in HbA1c under the study Testosterone Supplementation regimen.
Time frame: 90 day study period
The record gives a start of Oct 2011, a primary completion of Sep 2012 and a completion of Sep 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Singapore Clinical Research Institute