28-Day Study of Testosterone Co-Administered With Dutasteride in Hypogonadal Men
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadism
Intervention: Nanomilled testosterone (Drug); Nanomilled dutasteride (Drug); commercially available dutasteride (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, M.D., Ph.D., FACP, Study Director, Affiliation: GlaxoSmithKline
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.
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: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Male.
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.
Locations and Contacts
GSK Clinical Trials Call Center, Torrance, California 90509, United States
GSK Clinical Trials Call Center, Louisville, Kentucky 40202, United States
GSK Clinical Trials Call Center, Baltimore, Maryland 21287, United States
GSK Clinical Trials Call Center, Durham, North Carolina 27710, United States
GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States
GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States
GSK Clinical Trials Call Center, Salt Lake City, Utah 84108, United States
GSK Clinical Trials Call Center, Seattle, Washington 98108, United States
GSK Clinical Trials Call Center, Seattle, Washington 98195, United States
Additional Information
Starting date: October 2006
Last updated: January 29, 2008
|
