28-Day Study of Testosterone Co-administered with Dutasteride in Hypogonadal Men
Trial overview
Average serum testosterone concentration over 24 hour (h) for each treatment arm on Day 28
Timeframe: Day 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)
The percentage of participants classified as responders (24-hr C average (Cavg) within normal limits) for each treatment arm on Day 28. .
Timeframe: Day 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)
Number of participants with Adverse events (AE) and serious adverse events (SAE)
Timeframe: Up to 28 days (Visit 10)
Change from baseline in vital signs (heart rate)
Timeframe: Baseline (Day 1, pre -dose), Day 1 (24 h) and Visit 10 (Day 28, 24 h)
Changes from baseline in systolic and diastolic blood pressure (SBP and DBP)
Timeframe: Baseline (Day 1, pre -dose), Day 1 (24 h) and Visit 10 (Day 28, 24 h)
Participants with 12-lead electrocardiogram (ECG) values outside the normal range of potential clinical importance (PCI)
Timeframe: Up to Visit 10
Participants with hematology values outside the normal range PCI
Timeframe: Up to Visit 10 (Follow up)
Participants with clinical chemistry values outside the normal range (PCI)
Timeframe: Up to Visit 10
Area under curve (AUC) for T, Dihydrotestosterone (DHT), as appropriate: AUC (0-12h), AUC (12-24h), AUC (0-24h) on Day 1 and 28
Timeframe: Day 1 and 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)
Pharmacokinetic parameters for D as AUC(0-12h), AUC(12-24h), AUC(0-24h) on Day 1 and Day 28
Timeframe: Day 1 and Day 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)
Maximum observed plasma drug concentration (Cmax) for T and DHT on Day 1 and Day 28
Timeframe: Day 1 and 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)
Cmax for D on Day 1 and Day 28
Timeframe: Day 1 and Day 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)
AUC for estradiol and estrone as appropriate: AUC(0-12h), AUC(12-24h), AUC(0-24h) on Day 1 and Day 28
Timeframe: Day 1 and Day 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)
Cmax for estradiol and estrone on Day 1 and Day 28.
Timeframe: Day 1 and Day 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)
Time at which Cmax was observed (Tmax) for T, DHT, estradiol and estrone
Timeframe: Day 1 and Day 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)
Tmax for D on Day 1 and 28
Timeframe: Day 1 and Day 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)
The percentage of participants classified as responders (24-h Cavg within normal limits) for each treatment arm on Day 1
Timeframe: Day 1 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)
Average serum T concentration over 24 h for each treatment arm on Day 1.
Timeframe: Day 1 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)
DHT and DHT/T ratio AUC (0-24h) on Day 1 and Day 28
Timeframe: Day 1 and Day 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)
Pre-dose concentrations of T immediately prior to morning dosing on Day 28
Timeframe: Day 28 (pre-dose)
Pre-dose concentrations of D immediately prior to morning dosing on Day 28
Timeframe: Day 28
Number of participants with prostate specific antigen (PSA), or markers of anabolic effects on skeletal muscle.
Timeframe: Visit 5 (Day -1) and Visit 9 (Day 28)
Number of participants with androgenic Pharmacodynamic biomarkers
Timeframe: Up to Visit 10 (at Visit 5 and Visit 9)
Participation criteria
- Have a diagnosis of primary or secondary hypogonadism.
- Have very low testosterone levels on 2 separate days.
- Have had or have breast or prostate cancer, malabsorption syndrome, sleep apnea, psychiatric illness, polycythemia, or any other clinically significant current condition.
- Are diabetic with an HbA1c >= 8.
- Have a diagnosis of primary or secondary hypogonadism.
- Have very low testosterone levels on 2 separate days.
- Have a BMI within range of 18.5-35kg/m2.
- Have not taken dutasteride for one year, or finasteride for the past 3 months.
- Have had or have breast or prostate cancer, malabsorption syndrome, sleep apnea, psychiatric illness, polycythemia, or any other clinically significant current condition.
- Are diabetic with an HbA1c >= 8.
- Are taking any androgens, such as testosterone, saw palmetto.
- Are taking ritonavir, indinavir, itraconazole, ketoconazole, erythromycin, warfarin, digoxin, cholestyramine, or any dietary/herbal/vitamin supplements.
- Would donate more than 500 ML of blood over a 2 month period.
- Physician does not think it is a good idea for you to participate in the trial.
- Are unwilling to abstain from alcohol during the study.
- Have a positive urine drug screen test.
- Plan to change your smoking habits during the course of the trial.
- Have Hepatitis C, Hepatitis B, or HIV.
- Have a lab or EKG abnormality.
- High or low blood pressure.
- Have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.