CLINICAL TRIALS PROFILE FOR DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

All Clinical Trials for dutasteride; tamsulosin hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
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)
NCT00701779 ↗	Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia	Completed	Siami, Paul F., M.D.	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)
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.

Clinical Trial Conditions for dutasteride; tamsulosin hydrochloride

Condition Name

Condition Name for dutasteride; tamsulosin hydrochloride
Intervention	Trials
Prostatic Hyperplasia	14
Benign Prostatic Hyperplasia	5
Urologic Diseases	2
Prostate Cancer	1

Condition MeSH

Condition MeSH for dutasteride; tamsulosin hydrochloride
Intervention	Trials
Prostatic Hyperplasia	18
Hyperplasia	18
Urologic Diseases	3
Hypertrophy	2

Clinical Trial Locations for dutasteride; tamsulosin hydrochloride

Trials by Country

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−

Trials by Country for dutasteride; tamsulosin hydrochloride
Location	Trials
United States	42
Germany	31
Italy	20
United Kingdom	12
France	11

Trials by US State

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−

Trials by US State for dutasteride; tamsulosin hydrochloride
Location	Trials
Maryland	3
Indiana	3
Ohio	2
New York	2
Texas	2

Clinical Trial Progress for dutasteride; tamsulosin hydrochloride

Clinical Trial Phase

Clinical Trial Phase for dutasteride; tamsulosin hydrochloride
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	5
Phase 1	11

Clinical Trial Status

Clinical Trial Status for dutasteride; tamsulosin hydrochloride
Clinical Trial Phase	Trials
Completed	17
Terminated	2
Recruiting	1

Clinical Trial Sponsors for dutasteride; tamsulosin hydrochloride

Sponsor Name

Sponsor Name for dutasteride; tamsulosin hydrochloride
Sponsor	Trials
GlaxoSmithKline	18
The Cleveland Clinic	1
University of California, Los Angeles	1

Sponsor Type

Sponsor Type for dutasteride; tamsulosin hydrochloride
Sponsor	Trials
Industry	18
Other	8
NIH	1

Dutasteride and Tamsulosin Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Dutasteride and Tamsulosin Hydrochloride

Dutasteride and tamsulosin hydrochloride are medications commonly used in the treatment of benign prostatic hyperplasia (BPH) and male pattern hair loss. Here, we will delve into the current clinical trials, market analysis, and future projections for these drugs.

Clinical Trials and Research

While there are no ongoing phase 3 clinical trials specifically for dutasteride and tamsulosin hydrochloride combination, it is important to note the context in which these drugs are used.

Current Use and Related Trials

Dutasteride is primarily used for treating BPH and male pattern hair loss. It works by inhibiting the 5-alpha-reductase enzyme, which converts testosterone to dihydrotestosterone (DHT), a hormone that contributes to prostate enlargement and hair loss[2].

For BPH, dutasteride is often combined with tamsulosin, an alpha-blocker that relaxes the muscles in the prostate and bladder neck, making it easier to urinate. This combination is well-established and has been approved by regulatory bodies such as the FDA[5].

Related Clinical Trials

Although there are no new phase 3 trials for the combination of dutasteride and tamsulosin, other related trials are worth mentioning. For instance, trials involving androgen receptor blockers, like Breezula® (a higher-strength version of clascoterone), are underway for treating male pattern hair loss. These trials indicate ongoing research in the field of hormonal treatments for conditions related to BPH and hair loss[1].

Market Analysis

Market Size and Growth

The market for dutasteride and tamsulosin hydrochloride is significant, driven by the increasing incidence of BPH and male pattern hair loss globally. The estimated market size for dutasteride and tamsulosin hydrochloride capsules was around $9 million for the twelve months ending May 2024[5].

Market Drivers

• Increasing Incidence of BPH: The growing number of men suffering from BPH is a major driver for the demand of dutasteride and tamsulosin hydrochloride. Men aged 50 and above are more prone to prostate enlargement, contributing to market growth[2].
• Therapeutic Efficiency: The effectiveness of dutasteride in managing hormonal imbalances and reducing DHT levels makes it a preferred treatment option, driving market demand[2].

Market Restraints

• Regulatory Challenges: Regulatory hurdles and compliance issues can limit the expansion of the market. For example, generic versions must meet strict FDA guidelines to be approved as AB-rated equivalents[5].
• High Development Costs: The cost of developing new formulations or applications of dutasteride can be a significant barrier to innovation and market expansion[2].

Competitive Landscape

The market for dutasteride and tamsulosin hydrochloride is competitive, with several pharmaceutical companies involved. Aurobindo Pharma Limited, for instance, has received FDA approval for its generic version of dutasteride and tamsulosin hydrochloride capsules, which is an AB-rated generic equivalent to Jalyn Capsules[5].

Porter’s Five Forces Analysis

This analysis helps in understanding the competitive position and power dynamics in the market.

• Threat of New Entrants: The market is moderately competitive, with barriers to entry such as high development costs and regulatory challenges.
• Bargaining Power of Suppliers: Suppliers have moderate bargaining power due to the availability of generic versions.
• Bargaining Power of Buyers: Buyers have significant bargaining power due to the presence of multiple generic options.
• Threat of Substitute Products: There is a moderate threat from substitute products, such as other treatments for BPH and hair loss.
• Competitive Rivalry Among Existing Competitors: The market is highly competitive, with multiple players offering similar products[2].

Market Projections

Market Size and Share

The dutasteride drug market, including its combination with tamsulosin, is expected to grow significantly over the next few years. The global market size for dutasteride is projected to increase due to the rising incidence of BPH and male pattern hair loss, as well as the expanding use of dutasteride in other therapeutic areas such as cancer treatments and precision medicine[2].

Innovations and Future Applications

• Cancer Treatments: There is potential for dutasteride to be used in cancer treatments, particularly in prostate cancer, by inhibiting the growth of cancer cells through hormonal regulation[2].
• Precision Medicine: The use of dutasteride in precision medicine and personalized healthcare solutions is an area of growing interest and potential growth[2].

Distribution and Supply Chain

Optimizing supply chain logistics can significantly reduce lead times and costs in the delivery of dutasteride and tamsulosin hydrochloride. Partnering with digital health platforms can also streamline prescriptions and patient management, enhancing market efficiency[2].

Key Takeaways

• Clinical Trials: While there are no new phase 3 trials for the combination, ongoing research in related areas like androgen receptor blockers is promising.
• Market Growth: The market is driven by increasing incidence of BPH and hair loss, with a projected growth due to therapeutic efficiency and expanding applications.
• Competitive Landscape: The market is competitive with multiple players, including generic versions, and is influenced by regulatory and development costs.
• Future Applications: Potential uses in cancer treatments and precision medicine offer lucrative paths for growth.

FAQs

What is the primary use of dutasteride and tamsulosin hydrochloride?

Dutasteride and tamsulosin hydrochloride are primarily used for treating symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

How does dutasteride work?

Dutasteride works by inhibiting the 5-alpha-reductase enzyme, which converts testosterone to dihydrotestosterone (DHT), a hormone that contributes to prostate enlargement and hair loss.

What is the current market size for dutasteride and tamsulosin hydrochloride capsules?

The estimated market size for dutasteride and tamsulosin hydrochloride capsules was around $9 million for the twelve months ending May 2024.

Are there any new clinical trials for dutasteride and tamsulosin hydrochloride?

There are no new phase 3 clinical trials specifically for the combination of dutasteride and tamsulosin hydrochloride, but related trials in the field of hormonal treatments are ongoing.

What are the potential future applications of dutasteride?

Dutasteride has potential future applications in cancer treatments, particularly prostate cancer, and in precision medicine and personalized healthcare solutions.

Sources

1. Hair Science: "Breezula® Phase 3 Clinical Trials for Male Pattern Hair Loss Begin" - July 2023
2. 360iResearch: "Dutasteride Drug Market Size & Share 2025-2030"
3. Business Wire: "Dutasteride / Tamsulosin Sales, Price Analysis, & Sales Forecasts 2017"
4. Bayer Clinical Trials Explorer: "Prostate Cancer | Study 20963 | Bayer"
5. Chain Drug Review: "Aurobindo gets FDA approval for dutasteride and tamsulosin hydrochloride capsules" - July 2024