NCT00398580

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

November 8, 2006

Last Update Submit

May 25, 2017

Conditions

HypogonadismHypogonadism, Male

Keywords

DHTTestosteroneHypogonadismDutasterideAndrogen deficiency

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Testosterone concentration .

    on days 1 and 28

  • Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride

    days 1 and 28.

  • Anabolic & androgenic Pharmacodynamic biomarkers

    pre- and post-dose

Interventions

Nanomilled testosteroneDRUG
Nanomilled dutasterideDRUG
commercially available dutasterideDRUG
Also known as: Nanomilled testosterone, Nanomilled dutasteride

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

GSK Investigational Site

Torrance, California, 90502, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40202, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21287, United States

Location

GSK Investigational Site

Durham, North Carolina, 27710, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Seattle, Washington, 98108, United States

Location

GSK Investigational Site

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

HypogonadismEunuchism

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Officials

  • GSK Clinical Trials, M.D., Ph.D., FACP

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2006

First Posted

November 10, 2006

Study Start

October 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(7)