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Clinical Trial Details

Trial ID: L6780
Source ID: NCT01510847
Associated Drug: Andriol Testocaps
Title: The Effect of 90-day Oral Testosterone Therapy in Chinese Males With Type 2 Diabetes (T2DM)
Acronym: OTEST
Status: TERMINATED
Study Results: NO
Results:
Conditions: 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.
Interventions: DRUG: Andriol Testocaps
Outcome Measures: Primary: 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., 90 Day Study Period | Secondary: 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., 90 day study period
Sponsor/Collaborators: Sponsor: Singapore Clinical Research Institute | Collaborators: Singapore General Hospital|Duke-NUS Graduate Medical School
Gender: MALE
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 19
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2011-10
Completion Date: 2012-09
Results First Posted:
Last Update Posted: 2016-01-06
Locations: Camry Medical Centre, Singapore, 310095, Singapore|Frontier Medical Associates (Ubi) Pte Ltd, Singapore, 400305, Singapore|Everhealth Medical Centre, Singapore, 530540, Singapore|Frontier Medical Associates (Buangkok Cresent) Pte Ltd, Singapore, 530982, Singapore|Frontier Medical Associates (AMK) Pte Ltd, Singapore, 560163, Singapore|EJ Tan Clinic & Surgery, Singapore, 600104, Singapore|Everhealth Family Clinic & Surgery, Singapore, 640762, Singapore|Bukit Batok Medical Clinic, Singapore, 650207, Singapore|Princeton Family Clinic Pte Ltd, Singapore, 670445, Singapore|The Edinburgh Clinic, Singapore, 680306, Singapore|Frontier Medical Associates (Woodlands) Pte Ltd, Singapore, 732899, Singapore|Frontier Medical Associates (Yishun) Pte Ltd, Singapore, 760654, Singapore
URL: https://clinicaltrials.gov/show/NCT01510847

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