HypogonadismPhase 4DUT/TNCT00752869
Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement
A Phase 4 study testing dutasteride in people with Hypogonadism, run by The Miriam Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- dutasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2008to Mar 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- Subject is able to read and comprehend the informed consent document.
- 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.
Who cannot join
- Use of medications including those interactive with dutasteride from prior studies
- Hematocrit greater than 51%
- Prostate cancer in men found to have a prostate nodule on initial exam and subsequent positive biopsy
- No prostate surgery within 2 months of entry
- No prior use of finasteride, dutasteride within 6 months prior
- 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.
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- No serum creatinine greater than 2.0 times upper limit of normal
- No history of alcohol abuse with last 12 months
- Has received any medication in a clinical trial within 2 months of enrollment
- Use of anti-androgens, estrogens or coumadin
- 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.
- History of or current prostate or breast cancer
- Baseline EKG with clinically significant abnormal rhythm or abnormal QT interval
- Systolic blood pressure above 170mmHg or diastolic blood pressure above 90 mm Hg on baseline physical exam
- Clinically significant peripheral edema on baseline physical exam
- History of sleep apnea
- History of psychiatric disorders or major depression
- Consumption of grapefruit juice within 7 days of enrollment or is unwilling to eliminate use of grapefruit juice during the study period
- History of allergy to study medication
- Hemoglobin A1c > 9% in a non-insulin dependent diabetic
- Subjects with abnormal thyroid function
- Subjects with significantly elevated triglycerides
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Men's Health Boston
Boston, Massachusetts, 002445
The Miriam Hospital
Providence, Rhode Island, 02906
About this study
Official title: Dutasteride in Men Receiving Testosterone Therapy: Impact on Serum PSA, Testosterone, DHT Levels and Prostate Volume: "Implications for Prostate Safety"
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).
Read more
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.
Read the detailed description
Termination criteria
- Serum AST or ALT > 3 times ULN
- 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.
- Hematocrit > 55%
- Subject experiences any unacceptable or intolerable adverse effect.
- Subject is non-compliant with the study protocol.
- Subject needs to take any medication that would interfere with study measurements
- Subject develops prostate or breast cancer
- Conditions
- Hypogonadism
- Being tested
- dutasteride, placebo
- Keywords
- low testosterone
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dutasterideDrug
Also called Avodart, chemical # c27H30F6N202, g1 198745, ind 64,789
0.5mg by mouth one time per day for 1 year
placeboDrug
Also called Inactive substance
one tablet per day for 1 year
| Study group | Role | What they receive |
|---|---|---|
| B | Placebo comparator | This group will meet the same inclusion and exclusion criteria as the group receiving the study drug Receives: Drug: placebo |
| A | Active comparator | This arm will receive the active medication dutasteride Receives: Drug: dutasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA reduction
Measured: with up to 12 months of treatment
Secondary outcomes (4)
PV reduction with up to 12 months of treatment
Measured: 1 year treatment
DHT and T levels: serum
Measured: 1 year treatment
Prostatic TRUS pre and post treatment
Measured: 1 year treatment
IIEF; MHSQ: Questionnaires examining the domains of erectile and orgasmic function in men in the two treatment arms
Measured: 1 year treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Martin M. Miner, MD, The Miriam Hospital
- Investigators
- Martin M Miner, MD, Principal investigator, The Miriam HospitalAbraham Morgentaler, MD, Principal investigator, Men's Health Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752869
- Sponsor's protocol ID
- GSK 111504
- Other IDs
- FDA IND # 101,619
- Acronym
- DUT/T
- Status last verified
- Feb 2013
- First submitted
- 15 Sep 2008
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dutasteride in Men Receiving Testosterone Therapy: Impact on Serum PSA, Testosterone, DHT Levels and Prostate Volume: "Implications for Prostate Safety"
- ClinicalTrials.gov ID
- NCT00752869
- Acronym / sponsor ID
- DUT/T / GSK 111504
- Conditions
- Hypogonadism
- Keywords
- low testosterone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 16 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Termination criteria
- Serum AST or ALT > 3 times ULN
- 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.
- Hematocrit > 55%
- Subject experiences any unacceptable or intolerable adverse effect.
- Subject is non-compliant with the study protocol.
- Subject needs to take any medication that would interfere with study measurements
- Subject develops prostate or breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Placebo comparator | Drug: placeboThis group will meet the same inclusion and exclusion criteria as the group receiving the study drug |
| A | Active comparator | Drug: dutasterideThis arm will receive the active medication dutasteride |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Total Serum PSA >1.5 - 10 ng/mL
- Subject is able to read and comprehend the informed consent document.
- 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.
Key exclusion criteria (22 listed)
- Use of medications including those interactive with dutasteride from prior studies
- Hematocrit greater than 51%
- Prostate cancer in men found to have a prostate nodule on initial exam and subsequent positive biopsy
- No prostate surgery within 2 months of entry
- No prior use of finasteride, dutasteride within 6 months prior
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dutasterideAlso: Avodart, chemical # c27H30F6N202, g1 198745, ind 64,7890.5mg by mouth one time per day for 1 year | Drug | A |
| placeboAlso: Inactive substanceone tablet per day for 1 year | Drug | B |
Primary outcome
PSA reduction
Time frame: with up to 12 months of treatment
4 secondary outcomes
PV reduction with up to 12 months of treatment
Time frame: 1 year treatment
DHT and T levels: serum
Time frame: 1 year treatment
Prostatic TRUS pre and post treatment
Time frame: 1 year treatment
IIEF; MHSQ: Questionnaires examining the domains of erectile and orgasmic function in men in the two treatment arms
Time frame: 1 year treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin M Miner, MD principal investigator
The Miriam Hospital
Abraham Morgentaler, MD principal investigator
Men's Health Boston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dutasteride in people with Hypogonadism, run by The Miriam Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA reduction (time frame: with up to 12 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2013.