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CompletedNCT00398580Updated May 30, 2017

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

A Phase 2 interventional study of Nanomilled testosterone and Nanomilled dutasteride in Hypogonadism and Hypogonadism, Male, sponsored by GlaxoSmithKline. Completed at 7 sites in United States. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Hypogonadism
  • Hypogonadism, Male

Keywords

  • DHT
  • Testosterone
  • Hypogonadism
  • Dutasteride
  • Androgen deficiency
03

In context

Hypogonadism

345 studies on the registry are indexed under Hypogonadism; 43 are open to participants now.

This study's enrollment of 43 is below the median of 56 across 260 interventional studies indexed under Hypogonadism.

Browse Hypogonadism studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
43 participants (actual)

Interventions

  • DrugNanomilled testosterone
  • DrugNanomilled dutasteride
  • Drugcommercially available dutasteride

    Also known as: Nanomilled testosterone, Nanomilled dutasteride

06

What researchers measure

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

07

Study locations

7 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00398580
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Nov 10, 2006
Start date
Oct 2006
Primary completion
Oct 2007
Completion
Oct 2007
Last update
May 30, 2017

Study contacts

GSK Clinical Trials, M.D., Ph.D., FACP
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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