28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men

• ClinicalTrials.gov Identifier: NCT00398580
• Recruitment Status: Completed
• First Posted: November 10, 2006
• Last Update Posted: May 30, 2017
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Tracking Information

• First Submitted Date: November 8, 2006
• First Posted Date: November 10, 2006
• Last Update Posted Date: May 30, 2017
• Study Start Date: October 2006
• Actual Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 1, 2007): Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine [ Time Frame: days 1 and 28 ]

Original Primary Outcome Measures (submitted: November 8, 2006)

• Safety measured by: monitoring laboratory tests
• changes in blood pressure and heart rate
• and heart activity on an ECG machine days 1 and 28.

Current Secondary Outcome Measures (submitted: January 29, 2008)

• Testosterone concentration . [ Time Frame: on days 1 and 28 ]
• Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride [ Time Frame: days 1 and 28. ]
• Anabolic & androgenic Pharmacodynamic biomarkers [ Time Frame: pre- and post-dose ]

Original Secondary Outcome Measures (submitted: November 8, 2006)

• Testosterone concentration on days 1 and 28
• Pharmacokinetics of testosterone, DHT, estradiol, estrone and dutasteride days 1 & 28.
• Anabolic and androgenic Pharmacodynamic biomarkers pre- and post-dose.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
• Official Title: A Phase II, 28-Day, Randomized, Parallel-Group, Open-Label Study Evaluating the Efficacy and Safety of Twice Daily Oral Doses of Testosterone (150-400mg) Co-administered With 0.25mg Dutasteride Compared With 400mg Testosterone Alone and 0.25mg Dutasteride Alone in the Treatment of Hypogonadism
• Brief Summary: The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the effect of 28-day repeat dosing of this combination with varying BID doses of testosterone (T), in combination with a fixed BID dose of dutasteride (D), as well as a testosterone alone arm, on T and D levels in the blood. The rationale is to look for the effects of each compound on the other, and to look for any safety problems that may result when the 2 drugs are given together.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Hypogonadism
• Hypogonadism, Male

Intervention

• Drug: Nanomilled testosterone
• Drug: Nanomilled dutasteride
• Drug: commercially available dutasteride
  Other Names:

  • Nanomilled testosterone
  • Nanomilled dutasteride

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 29, 2008): 43
• Original Enrollment (submitted: November 8, 2006): 100
• Actual Study Completion Date: October 2007
• Actual Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00398580
• Other Study ID Numbers: TDC106220
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: GlaxoSmithKline
• Study Sponsor: GlaxoSmithKline
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials, M.D., Ph.D., FACP; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: May 2017