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Completed

NCT Number: NCT00398580

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

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.

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Key information

Conditions

Hypogonadism Endocrine System Diseases Eunuchism Gonadal Disorders Hypogonadism, Male

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Torrance, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nanomilled testosterone

Drug

Nanomilled dutasteride

Drug

commercially available dutasteride

Drug

Other names: Nanomilled testosterone, Nanomilled dutasteride

Primary outcomes

  1. 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

Secondary outcomes

  1. Testosterone concentration .

    Time frame: on days 1 and 28

  2. Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride

    Time frame: days 1 and 28.

  3. Anabolic & androgenic Pharmacodynamic biomarkers

    Time frame: pre- and post-dose

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 10, 2006
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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