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Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement (DUT/T)

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ClinicalTrials.gov Identifier: NCT00752869
Recruitment Status : Completed
First Posted : September 16, 2008
Last Update Posted : February 26, 2013
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Martin M. Miner, MD, The Miriam Hospital

Brief Summary:

This is a study using two FDA approved medications: Testosterone and the study medication, Dutasteride (Avodart 0.5mg/day). Half of the subjects will receive dutasteride and half will receive a placebo. The study medication will be taken for 12 months.

The subjects participating in the study are men who are already taking their own testosterone supplement because they have low testosterone levels which may cause them to experience sexual function difficulties, have fatigue or other symptoms. Testosterone can have an adverse effect of causing an enlarged prostate (Benign Prostatic Hypertrophy) (BPH).

Dutasteride (Avodart) is an approved medication used to decrease the prostate size, prevent urinary symptoms and reduce the risk of surgery.

The researchers would like to see if by taking dutasteride and testosterone at the same time they can prevent the adverse effects of testosterone and at the same time get the positive benefits of testosterone.

There will be 6 scheduled visits for the study and 2 diagnostic tests called a TRUS (TransRectal UltraSound), to evaluate prostate size. The six visits at will include consenting, blood work, two sexual function questionnaires, a physical examination, physical measurements, study medication teaching and dispensing of study medication.


Condition or disease Intervention/treatment Phase
Hypogonadism Drug: dutasteride Drug: placebo Phase 4

Detailed Description:

Termination criteria

  1. Serum AST or ALT > 3 times ULN
  2. Total serum bilirubin > 1.5 times ULN

    • no study termination of a patient with documented Gilberts disease for an isolated bilirubin elevation unless it exceeds 2.5x the upper limit of normal.
  3. Hematocrit > 55%
  4. Subject experiences any unacceptable or intolerable adverse effect.
  5. Subject is non-compliant with the study protocol.
  6. Subject needs to take any medication that would interfere with study measurements
  7. Subject develops prostate or breast cancer

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dutasteride in Men Receiving Testosterone Therapy: Impact on Serum PSA, Testosterone, DHT Levels and Prostate Volume: "Implications for Prostate Safety"
Study Start Date : September 2008
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: B
This group will meet the same inclusion and exclusion criteria as the group receiving the study drug
Drug: placebo
one tablet per day for 1 year
Other Name: Inactive substance

Active Comparator: A
This arm will receive the active medication dutasteride
Drug: dutasteride
0.5mg by mouth one time per day for 1 year
Other Names:
  • Avodart
  • chemical # c27H30F6N202
  • g1 198745
  • ind 64,789
  • code name nda 021319




Primary Outcome Measures :
  1. PSA reduction [ Time Frame: with up to 12 months of treatment ]

Secondary Outcome Measures :
  1. PV reduction with up to 12 months of treatment [ Time Frame: 1 year treatment ]
  2. DHT and T levels: serum [ Time Frame: 1 year treatment ]
  3. Prostatic TRUS pre and post treatment [ Time Frame: 1 year treatment ]
  4. IIEF; MHSQ: Questionnaires examining the domains of erectile and orgasmic function in men in the two treatment arms [ Time Frame: 1 year treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects currently on stable testosterone replacement therapy for 3 months' duration using either the approved transdermal products Androgel® or Testim®, or injections of testosterone enanthate or cypionate with a morning serum testosterone concentration within the normal range (300 - 1000 ng/dl). These will dispensed either by prescription or for injections by the PI or co-PI in the office.
  2. Total Serum PSA >1.5 - 10 ng/mL

    • If the total serum PSA is >4ng/mL, the investigator, or a qualified urologist, will perform a 12-core prostate biopsy prior to entry unless such a biopsy has already been performed within the past 6 months.
    • If the PSA rises above 4 during any time of the study, the patient will be referred to urology for biopsy.
    • Patients with any suspicious rise in PSA of >1.0 ng/ml/yr will have a repeat PSA performed within one month of the original value. If the rise in PSA remains >1.0 ng/ml/yr, the patient will undergo a prostate biopsy.
    • b. If the individual has had a negative biopsy more than 6 months previously, with documentation of stable PSA since that time, ie, no sustained increase >1.0ng/ml.
  3. Subject is able to read and comprehend the informed consent document.
  4. If the subject is on current replacement therapy for hypopituitarism or other multiple endocrine abnormalities, the subject must be on stable doses of thyroid hormone and/or adrenal replacement hormones for at least 14 days prior to enrollment.

Exclusion Criteria:

  1. Use of medications including those interactive with dutasteride from prior studies
  2. Hematocrit greater than 51%
  3. Prostate cancer in men found to have a prostate nodule on initial exam and subsequent positive biopsy
  4. No prostate surgery within 2 months of entry
  5. No prior use of finasteride, dutasteride within 6 months prior
  6. A history of hepatic impairment or abnormal liver function tests (defined as ALT, AST, alkaline phosphatase or bilirubin >1.5 times the upper limit of normal) with the exception that bilirubin elevations up to 2.0 times the upper limit of normal in the presence of normal liver enzymes will be permitted in patients with documented Gilbert's Disease. Subjects with Gilbert's disease not to be excluded.
  7. No serum creatinine greater than 2.0 times upper limit of normal
  8. No history of alcohol abuse with last 12 months
  9. Has received any medication in a clinical trial within 2 months of enrollment
  10. Use of anti-androgens, estrogens or coumadin
  11. A history or evidence of newly discovered prostate cancer (e.g. positive biopsy or ultrasound, suspicious DRE). In patients with suspicious ultrasound or DRE, including patients with a focal nodule, biopsy shall be performed by a qualified urologist upon study entry unless one was performed and found to be negative within the preceding 6 months.
  12. History of or current prostate or breast cancer
  13. Baseline EKG with clinically significant abnormal rhythm or abnormal QT interval
  14. Systolic blood pressure above 170mmHg or diastolic blood pressure above 90 mm Hg on baseline physical exam
  15. Clinically significant peripheral edema on baseline physical exam
  16. History of sleep apnea
  17. History of psychiatric disorders or major depression
  18. Consumption of grapefruit juice within 7 days of enrollment or is unwilling to eliminate use of grapefruit juice during the study period
  19. History of allergy to study medication
  20. Hemoglobin A1c > 9% in a non-insulin dependent diabetic
  21. Subjects with abnormal thyroid function
  22. Subjects with significantly elevated triglycerides

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752869


Locations
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United States, Massachusetts
Men's Health Boston
Boston, Massachusetts, United States, 002445
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
The Miriam Hospital
GlaxoSmithKline
Investigators
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Principal Investigator: Martin M Miner, MD The Miriam Hospital
Principal Investigator: Abraham Morgentaler, MD Men's Health Boston

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Responsible Party: Martin M. Miner, MD, Principal Investigator, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT00752869     History of Changes
Other Study ID Numbers: GSK 111504
FDA IND # 101,619
First Posted: September 16, 2008    Key Record Dates
Last Update Posted: February 26, 2013
Last Verified: February 2013
Keywords provided by Martin M. Miner, MD, The Miriam Hospital:
low testosterone
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Dutasteride
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists