CLINICAL TRIALS PROFILE FOR AVODART

All Clinical Trials for AVODART

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00161421 ↗	Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	2005-03-01	The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive.
NCT00161421 ↗	Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone	Completed	GlaxoSmithKline	Phase 2	2005-03-01	The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive.
NCT00161421 ↗	Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone	Completed	National Institutes of Health (NIH)	Phase 2	2005-03-01	The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive.
NCT00161421 ↗	Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone	Completed	University of Washington	Phase 2	2005-03-01	The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive.
NCT00244309 ↗	Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer	Completed	GlaxoSmithKline	Phase 3	2005-11-01	The purpose of this study is to determine whether a drug named tamsulosin (Flomax), or another drug named dutasteride (Avodart), or a combination of these two drugs is effective in improving urinary symptoms and decreasing the rate of intermittent self-catheterization after prostate brachytherapy.
NCT00244309 ↗	Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer	Completed	Case Comprehensive Cancer Center	Phase 3	2005-11-01	The purpose of this study is to determine whether a drug named tamsulosin (Flomax), or another drug named dutasteride (Avodart), or a combination of these two drugs is effective in improving urinary symptoms and decreasing the rate of intermittent self-catheterization after prostate brachytherapy.
NCT00303446 ↗	Dutasteride to Treat Spinal and Bulbar Muscular Atrophy (SBMA)	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2006-03-01	This study will determine if the drug dutasteride can improve weakness, mobility, functioning, nerve function, and quality of life in patients with spinal and bulbar muscular atrophy (SBMA). Patients with this inherited disease have an abnormal androgen receptor protein. The male hormones testosterone and dihydrotestosterone (DHT) bind to this abnormal receptor, causing damage to nerve cells that innervate muscle and leading to weakness. Dutasteride decreases DHT production. Lowering DHT levels may decrease the harmful effects of DHT to the nerves and improve strength in people with SBMA. Males 18 years of age and older with SBMA who have neurological symptoms and can walk 100 feet (with or without assistive devices) may be eligible for this study. Candidates are screened with a blood test and a review of their medical records and genetic studies. Participants undergo the following procedures: - Blood and urine tests, history and physical examination, assessment of muscle strength - Quality-of-life questionnaire - Tests to assess functional abilities, such walking up steps, keeping the head up while lying down, and other measures - Nerve conduction study and motor unit number estimation to assess nerve damage. A probe placed on the skin delivers small electrical impulses and wires taped to the skin record the impulses. - Quantitative muscle testing to measure strength. The subject pushes and pulls levers attached to a gauge. Strength is recorded by a computer. - Medication. Participants are divided into two groups. One group is given the study drug, dutasteride; the other receives a placebo (sugar pill). All participants take their assigned medication once a day for 24 months. - Follow-up evaluations. Every 6 months for 2 years, participants return to NIH to repeat the tests described above to determine the effects of the dutasteride. Nerve and quantitative muscle testing is not done at the 6- and 18-month visits. - In addition to their follow-up appointments here at the NIH every 6 months, participants will also have blood tests and a physical examination performed after 3, 9, 15 and 21 months of treatment by the patient's local physician.

Clinical Trial Conditions for AVODART

Condition Name

Condition Name for AVODART
Intervention	Trials
Prostate Cancer	11
Prostatic Hyperplasia	6
Benign Prostatic Hyperplasia	5
Alcoholism	4

Condition MeSH

Condition MeSH for AVODART
Intervention	Trials
Prostatic Neoplasms	13
Prostatic Hyperplasia	12
Hyperplasia	10
Alcoholism	5

Clinical Trial Locations for AVODART

Trials by Country

Trials by Country for AVODART
Location	Trials
United States	56
Germany	10
United Kingdom	6
Korea, Republic of	6
Canada	5

Trials by US State

Trials by US State for AVODART
Location	Trials
Washington	7
Connecticut	6
Massachusetts	6
Illinois	3
Colorado	2

Clinical Trial Progress for AVODART

Clinical Trial Phase

Clinical Trial Phase for AVODART
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	7
Phase 3	2

Clinical Trial Status

Clinical Trial Status for AVODART
Clinical Trial Phase	Trials
Completed	29
Not yet recruiting	2
Unknown status	2

Clinical Trial Sponsors for AVODART

Sponsor Name

Sponsor Name for AVODART
Sponsor	Trials
GlaxoSmithKline	17
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	5
University of Washington	5

Sponsor Type

Sponsor Type for AVODART
Sponsor	Trials
Other	36
Industry	21
NIH	12

Avodart (dutasteride): Clinical Trials Update and Market Projection

Last updated: April 28, 2026

What is Avodart and what are its clinical trial pillars?

Avodart is dutasteride, a 5α-reductase inhibitor that lowers conversion of testosterone to dihydrotestosterone (DHT). Clinically, the product is positioned for benign prostatic hyperplasia (BPH) and symptomatic BPH with risk of progression (including acute urinary retention and surgery).

Key clinical endpoints used across the dutasteride BPH program

Across dutasteride’s late-stage BPH development and follow-on evidence, the dominant efficacy endpoints are:

• Symptom relief: International Prostate Symptom Score (IPSS)
• Disease progression prevention: time to acute urinary retention and time to BPH-related surgery
• Disease modification biology: prostate volume reduction and DHT suppression

Core Phase 3 evidence that anchors current labeling

The pivotal dutasteride Phase 3 evidence for BPH progression is built on two large, multi-year randomized trials:

• Combination therapy vs monotherapy and dutasteride vs placebo evaluated progression endpoints over multi-year follow-up and established superiority in reducing acute urinary retention and surgery relative to placebo in men at risk of progression. (European Medicines Agency EPAR for Avodart; FDA labeling for dutasteride)[1,2]

What is the latest clinical trials activity for dutasteride (Avodart)?

A complete “latest trials update” requires up-to-date registry searches (e.g., ClinicalTrials.gov and other national registries) filtered by dutasteride and Avodart, including study statuses (recruiting, active, suspended, completed) and results availability.

No registry dataset is provided here, and the prompt does not include a date window or trial registry extracts. Under the operating constraints, producing a “clinical trials update” without a current registry snapshot would require speculation on trial status and recency, which is not permissible.

Where is Avodart in the market today?

Avodart is a mature, branded product in the BPH space and faces:

• Generic competition for dutasteride in most geographies where patents have expired or where brand exclusivity has ended.
• Therapy mix pressure from other BPH classes (alpha blockers, PDE5 inhibitors, and combination regimens) and from payer preferences for lower-cost options.

The current market reality is that Avodart pricing is constrained where generics are available, while brand differentiation persists mainly through formulary placement, patient stability on therapy, and institutional contracting.

Competitive positioning vs typical BPH standard-of-care

In BPH, dutasteride competes primarily against:

• Alpha blockers (fast symptom relief, less progression modification impact as monotherapy)
• Combination regimens (alpha blocker + 5α-reductase inhibitor)
• PDE5 inhibitors (for men with LUTS and comorbid erectile dysfunction, depending on guideline and label context)

What is the market trajectory and how should investors model it?

A numeric projection requires inputs that are not provided, including current market size by geography, branded share vs generic share, current prescription volumes, and payer dynamics. Without those baseline numbers and without a defined time horizon, any forecast would be fabricated.

Under the operating constraints, the only allowable “market analysis and projection” is a framework grounded in observable market forces rather than a numeric sales forecast.

Projection drivers (directional, tied to market structure)

The market trajectory for Avodart in most established markets follows these drivers:

1. Share shift to generics
   • As generic penetration increases, branded units and net sales typically compress, with residual sales supported by brand loyalty and contracting.
2. Progression-focused indication economics
   • Dutasteride’s clinical value is progression reduction (acute urinary retention and surgery), which can support reimbursement, but only if payers treat it as cost-effective versus alternatives.
3. Combination therapy uptake
   • Where combination regimens are preferred for men at risk of progression, dutasteride can retain clinical relevance even as brand declines.
4. Safety and adherence
   • Ongoing prescribing depends on tolerability, adherence, and patient acceptance of long-term therapy.

What does the evidence say about progression benefit (the commercial value proposition)?

The commercial rationale for dutasteride hinges on outcomes that shift downstream costs and utilization, notably:

• Reduced rates of acute urinary retention
• Reduced rates of BPH-related surgery

These endpoints were central to pivotal BPH program evidence and the basis for clinical positioning in labeling. (European Medicines Agency EPAR for Avodart; FDA labeling for dutasteride)[1,2]

Regulatory and label anchors that influence uptake

Avodart’s continuing market presence is supported by established labeling for BPH and risk-of-progression populations.

US and EU label anchoring (high-level)

• EU: Avodart EPAR covers dutasteride’s BPH indication and supports risk-of-progression use and dosing in the approved regimen. (EMA EPAR)[1]
• US: FDA-approved dutasteride labeling supports BPH treatment positioning and provides dosing and safety information used by prescribers and formularies. (FDA labeling)[2]

Actionable business implications (without numeric forecasting)

If you are underwriting branded value

• Model branded sales as structurally decelerating with generic penetration and only stabilizing where formularies restrict interchange or where contracting locks in brand.
• Tie volume assumptions to progression-risk cohorts and the durability of combination regimens.

If you are underwriting pipeline-adjacent R&D

Dutasteride’s long-term efficacy supports a continuing opportunity for:

• Fixed-dose combinations
• Improved adherence formulations
• Next-generation androgen pathway modulators aimed at maintaining progression benefit with improved tolerability

Key Takeaways

• Avodart (dutasteride) is clinically anchored by long-term BPH progression endpoints (acute urinary retention and BPH-related surgery), with symptom improvement measured by IPSS and prostate volume/DHT effects. (EMA EPAR; FDA labeling)[1,2]
• A true “latest clinical trials update” requires current registry results; without an up-to-date registry snapshot, no defensible recency status can be reported.
• Market direction is dominated by generic competition and payer-driven cost minimization, partially offset by dutasteride’s progression prevention value and combination regimen uptake.
• Investor modeling should treat branded Avodart as structurally pressured by generics, with remaining value concentrated in progression-risk cohorts and combination therapy channels.

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FAQs

1) What is Avodart’s mechanism of action?

Avodart (dutasteride) inhibits 5α-reductase, reducing conversion of testosterone to DHT, which is implicated in prostate growth and BPH progression. (FDA labeling; EMA EPAR)[2,1]

2) What are the key clinical endpoints that matter commercially for dutasteride?

The core progression endpoints are time to acute urinary retention and time to BPH-related surgery, supported by symptom and prostate/DHT-related effects. (EMA EPAR; FDA labeling)[1,2]

3) Does dutasteride work for symptom relief or progression prevention?

Both, but the commercial differentiator is progression prevention, while symptom improvement is measured alongside it using IPSS. (EMA EPAR; FDA labeling)[1,2]

4) How does generic competition typically affect Avodart?

Generic dutasteride generally compresses branded net sales through price erosion and formulary substitution, leaving branded performance more dependent on contracts, loyalty, and specific plan rules.

5) Why do combination regimens matter for dutasteride demand?

Combination use is often targeted to men at higher risk of progression, which aligns with dutasteride’s demonstrated progression modification evidence, supporting sustained utilization even as brand shifts.

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References

[1] European Medicines Agency. (n.d.). Avodart: EPAR - Product information and assessment. EMA.
[2] U.S. Food and Drug Administration. (n.d.). Dutasteride prescribing information (Avodart) and label details. FDA.