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

Hypogonadism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398580
• Other study ID #: TDC106220
• Status: Completed
• Phase: Phase 2
• First received: November 8, 2006
• Last updated: May 25, 2017
• Start date: October 2006
• Est. completion date: October 2007

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadism, Male

Intervention

Drug:
• Nanomilled testosterone

• Nanomilled dutasteride

• commercially available dutasteride

Locations

Country	Name	City	State
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine		days 1 and 28
Secondary	Testosterone concentration .		on days 1 and 28
Secondary	Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride		days 1 and 28.
Secondary	Anabolic & androgenic Pharmacodynamic biomarkers		pre- and post-dose