CLINICAL TRIALS PROFILE FOR DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

All Clinical Trials for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00090103 ↗	Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment	Completed	GlaxoSmithKline	Phase 3	2003-11-01	This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.
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.
NCT00537654 ↗	A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State	Completed	GlaxoSmithKline	Phase 1	2007-10-18	This study will be an open-label, randomized, single dose, three way partial crossover study in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0.5 milligram [mg]/0.4 mg) relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin hydrochloride 0.4 mg tablets in both the fed and fasted states. Approximately 98 healthy adult male subjects will be enrolled into the study. Subjects will receive single oral doses in 3 treatment periods and be randomized to one of twelve different treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) wherein A= commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state, B= fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fed state, C= commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state, D= fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fasted state. Each treatment period will be separated by a minimum 28 day washout period. The total duration of a subject's involvement in this study is approximately 15-18 weeks.
NCT00609596 ↗	A Study To Compare 3 Different Formulations Of Tamsulosin At Steady State.	Completed	GlaxoSmithKline	Phase 1	2008-02-26	Dutasteride and tamsulosin are to treat benign prostatic hyperplasia. Studies show that when given together, there is more improvement in symptoms than either drug alone. In this study, we are looking to see if 2 different formulations of tamsulosin in our combination capsules are the same after 7 days of dosing as the US commercial tamsulosin and dutasteride.
NCT00701779 ↗	Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia	Completed	GlaxoSmithKline	Phase 4	2005-09-01	This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia (BPH). At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin. After randomization, study visits are every 13 weeks for up to 52 Weeks. (Including Screening, (up to 7 clinic visits)

Clinical Trial Conditions for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

Condition Name

Condition Name for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Intervention	Trials
Prostatic Hyperplasia	14
Benign Prostatic Hyperplasia	5
Urologic Diseases	2
Lower Urinary Tract Symptoms	2

Condition MeSH

Condition MeSH for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Intervention	Trials
Prostatic Hyperplasia	20
Hyperplasia	18
Urologic Diseases	3
Hypertrophy	2

Clinical Trial Locations for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

Trials by Country

Trials by Country for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Location	Trials
United States	42
Germany	31
Italy	20
United Kingdom	12
France	11

Trials by US State

Trials by US State for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Location	Trials
Maryland	3
Indiana	3
Ohio	2
New York	2
Texas	2

Clinical Trial Progress for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	4
Phase 3	5

Clinical Trial Status

Clinical Trial Status for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	18
Terminated	2
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Sponsor	Trials
GlaxoSmithKline	18
The Cleveland Clinic	1
University of California, Los Angeles	1

Sponsor Type

Sponsor Type for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Sponsor	Trials
Industry	19
Other	10
NIH	1

Dutasteride and Tamsulosin Hydrochloride: Clinical-Stage Update, Market Dynamics, and Projection

Last updated: April 27, 2026

What is this fixed-dose combo and why does it matter commercially?

Dutasteride and tamsulosin hydrochloride is a fixed-dose combination used for benign prostatic hyperplasia (BPH). Dutasteride (5-alpha-reductase inhibitor) reduces dihydrotestosterone-driven prostate growth, while tamsulosin (alpha-1 blocker) improves urinary flow by relaxing smooth muscle in the prostate and bladder neck. In-market value is driven by:

• Dose adherence from combination packaging
• Symptom improvement and risk reduction claims tied to prostate size progression
• Competition vs. mono-therapies (dutasteride-only, tamsulosin-only) and other combination formulations

What is the current clinical-trials status?

No complete, reliably attributable, up-to-date clinical-trials set can be produced from the information available in the prompt alone. The response must not fabricate trial pipelines, study IDs, enrollment counts, phases, or readouts.

How does the BPH market behave and what does it imply for this combo?

Market structure

BPH treatment markets are typically segmented by:

• Symptom status (mild/moderate vs severe LUTS)
• Prostate volume and progression risk (patients more likely to benefit from 5-AR inhibition)
• Therapy line (alpha blocker initiation vs combination earlier in progression-risk patients)

Competitive set (practical substitution paths)

Core substitution risks come from:

• Alpha blockers alone (faster symptom relief; adherence and tolerability often stronger drivers than progression modulation)
• Dutasteride alone (progression risk reduction without rapid symptom relief)
• Other fixed-dose combinations in urology portfolios (brand-led switching, payer formulary positioning)

Commercial drivers

• Formulary access: how aggressively payers cover fixed-dose combos vs tiered generics
• Safety/tolerability: dizziness/orthostasis tied to alpha blockers; sexual AEs tied to 5-AR inhibition
• Urology prescribing patterns: combinations gain share when clinicians target progression-risk profiles (larger prostate, higher baseline PSA density, or history of progression)
• Generic erosion: long-tail demand persists, but pricing power depends on which patents and exclusivities still constrain competitors

What pricing and lifecycle factors decide near-term revenue?

Generic pressure and margin profile

For long-established BPH assets, revenue projection is typically constrained by:

• Patent and exclusivity expiration (entry of generics and authorized generics)
• Interchangeability and substitution rules in major markets
• Wholesale acquisition cost downtrends post-entry

Forecast logic for a fixed-dose combo

A defensible projection approach for this category uses:

1. Patient prevalence growth (aging demographics)
2. Therapy penetration (how many LUTS/BPH patients receive drug therapy vs watchful waiting)
3. Combination adoption rate (share vs monotherapies)
4. Net price erosion driven by generic competition
5. Channel mix (retail vs mail order; government program enrollment in aging cohorts)

Because the prompt provides no confirmed patent dates, exclusivities, or market sales baselines, no numeric revenue forecast can be produced without risking fabrication.

What is the investment and R&D lens for this product class?

Where new trials would be expected to create value (without claiming existing ones)

The development themes that typically matter for fixed-dose BPH combos are:

• Earlier-line use in progression-risk patients (biomarker stratification)
• Adherence and persistence improvements (once-daily regimens; fewer pills)
• Safety optimization to reduce discontinuations
• Comparative outcomes vs separate dosing (real-world endpoints)

This matters because, in mature BPH markets, “incremental clinical differentiation” is usually required to offset price erosion from generic entry.

Key diligence items for business decisions

A commercial assessment should track:

• Exclusivity status by jurisdiction (US, EU5, UK, Canada, key APAC markets)
• Competitor launches (authorized generics, multiple-source generics)
• Formulary status and prior authorization requirements
• Real-world persistence benchmarks (switch and discontinuation rates)

Market projection: what can be quantified from the provided prompt?

None. The prompt does not provide:

• current sales (global or by region)
• pricing or reimbursement constraints
• patent/exclusivity timelines
• any clinical trial identifiers or results
• any baseline forecast inputs

Producing numbers without these would create false precision.

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Key Takeaways

• Dutasteride plus tamsulosin is a fixed-dose BPH regimen combining progression risk reduction and symptom relief.
• Commercial outcomes depend more on formulary access, generic erosion, and combination adoption than on incremental clinical effects alone.
• A clinical-trials update and numeric market projection cannot be completed from the prompt without introducing unsupported claims.

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FAQs

1. Is dutasteride plus tamsulosin used for symptom relief or disease modification?
   It targets both: symptom improvement through tamsulosin and disease progression risk reduction through dutasteride.

2. Does combination therapy usually outperform monotherapy in clinical practice?
   Combination use is commonly favored when clinicians aim to balance rapid LUTS improvement with progression-risk mitigation.

3. What typically drives payer coverage for fixed-dose BPH combos?
   Coverage decisions usually hinge on net cost vs alternatives and evidence of progression-risk targeting plus tolerability.

4. How does generic entry affect revenues for this type of product?
   Generic substitution generally compresses prices and margins; volume can persist, but net revenue growth often slows sharply post-entry.

5. What R&D endpoints matter most for the next generation of BPH combos?
   Most value resides in endpoints tied to persistence/discontinuation, time to symptom worsening, and progression outcomes in defined risk groups.

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References (APA)

[1] FDA. (n.d.). Labeling for dutasteride/tamsulosin hydrochloride products (where applicable). U.S. Food and Drug Administration.
[2] EMA. (n.d.). EPAR and product information for dutasteride/tamsulosin combinations (where applicable). European Medicines Agency.
[3] NCBI Bookshelf. (n.d.). Benign prostatic hyperplasia clinical overview and treatment principles. National Center for Biotechnology Information.
[4] EAU. (n.d.). Guidelines on benign prostatic hyperplasia/LUTS. European Association of Urology.