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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadism; Hypogonadism, Male

Intervention: Nanomilled testosterone (Drug); Nanomilled dutasteride (Drug); commercially available dutasteride (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, M.D., Ph.D., FACP, Study Director, Affiliation: GlaxoSmithKline


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine

Secondary outcome:

Testosterone concentration .

Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride

Anabolic & androgenic Pharmacodynamic biomarkers


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Male.


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


- 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.

Locations and Contacts

GSK Investigational Site, Torrance, California 90502, United States

GSK Investigational Site, Louisville, Kentucky 40202, United States

GSK Investigational Site, Baltimore, Maryland 21287, United States

GSK Investigational Site, Durham, North Carolina 27710, United States

GSK Investigational Site, San Antonio, Texas 78229, United States

GSK Investigational Site, Seattle, Washington 98108, United States

GSK Investigational Site, Seattle, Washington 98195, United States

Additional Information

Starting date: October 2006
Last updated: March 29, 2013

Page last updated: August 23, 2015

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