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.

Clinical Trial Conditions for AVODART

Condition Name

Condition Name for AVODART
Intervention	Trials
Prostate Cancer	11
Prostatic Hyperplasia	6
Benign Prostatic Hyperplasia	5
Alcohol Abuse	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

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

Trials by US State

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−

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

Clinical Trial Progress for AVODART

Clinical Trial Phase

Clinical Trial Phase for AVODART
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	2
Phase 2/Phase 3	2

Clinical Trial Status

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

Clinical Trial Sponsors for AVODART

Sponsor Name

Sponsor Name for AVODART
Sponsor	Trials
GlaxoSmithKline	17
University of Washington	5
UConn Health	5

Sponsor Type

Sponsor Type for AVODART
Sponsor	Trials
Other	36
Industry	20
NIH	12

AVODART: Clinical Trials, Market Analysis, and Projections

Introduction

AVODART, also known as dutasteride, is a dual 5-alpha reductase inhibitor used primarily to treat the symptoms of benign prostatic hyperplasia (BPH) and, in some cases, to reduce the risk of acute urinary retention (AUR) and BPH-related surgery. Here, we will delve into the clinical trials, market analysis, and projections related to AVODART.

Clinical Trials and Safety Profile

REDUCE Trial

The most significant clinical trial associated with AVODART is the REDUCE (REduction by DUtasteride of prostate Cancer Events) trial. This 4-year trial involved men aged 50 to 75 years with a prior negative biopsy for prostate cancer and a baseline PSA between 2.5 ng/mL and 10.0 ng/mL. The trial found that while AVODART reduced the overall incidence of prostate cancer, it increased the incidence of high-grade prostate cancer (Gleason score 8-10) compared to the placebo group (1.0% vs 0.5%)[1][3].

Adverse Reactions

Clinical trials have also highlighted common adverse reactions associated with AVODART, including impotence, decreased libido, breast disorders (such as breast enlargement and tenderness), and ejaculation disorders. These adverse reactions were more pronounced when AVODART was used in combination with tamsulosin[1].

Regulatory Decisions

Following the REDUCE trial, GlaxoSmithKline (GSK) decided not to pursue global approval for the use of AVODART to reduce the risk of prostate cancer due to concerns over the clinical significance of reducing low-grade prostate cancer and the increased incidence of high-grade tumors. Regulatory agencies, including the FDA and European authorities, provided feedback that led to this decision[3].

Market Analysis

Current Market

AVODART is approved in over 90 countries for the treatment of BPH symptoms and, in some countries, for reducing the risk of AUR and BPH-related surgery. Despite the withdrawal of applications for prostate cancer risk reduction, AVODART remains a significant player in the BPH treatment market[3].

Competition and Market Dynamics

The market for BPH treatments is competitive, with other 5-alpha reductase inhibitors like finasteride (PROSCAR) also available. However, AVODART's dual inhibition mechanism sets it apart, offering a unique therapeutic profile. The market dynamics are influenced by the ongoing medical and scientific debate around the benefits and risks of 5-alpha reductase inhibitors[1][3].

Projections and Future Outlook

Patient Exposure and Safety Monitoring

As of the latest updates, AVODART has been extensively studied in clinical trials involving over 7,500 men with BPH, with an estimated 6.6 million patient-years of exposure. GSK continues to monitor the safety and performance of AVODART, ensuring that the risk/benefit profile remains favorable for BPH treatment[3].

Regulatory Updates and Label Changes

GSK works closely with regulatory agencies to update the labels for all dutasteride-containing medicines, incorporating relevant safety information from the REDUCE study and emphasizing the importance of regular PSA monitoring. These updates ensure that physicians and patients are well-informed about the benefits and risks associated with AVODART[3].

Conclusion

AVODART, while not approved for reducing the risk of prostate cancer, remains a crucial treatment option for men with BPH. The drug's safety profile, although complex, is well-monitored, and its benefits in treating BPH symptoms are well-established. As the market continues to evolve, GSK's commitment to ongoing research and regulatory compliance will be key in maintaining AVODART's position in the therapeutic landscape.

Key Takeaways

• AVODART is primarily used to treat BPH symptoms and reduce the risk of AUR and BPH-related surgery.
• The REDUCE trial highlighted an increased incidence of high-grade prostate cancer with AVODART.
• Common adverse reactions include impotence, decreased libido, and breast disorders.
• GSK has withdrawn applications for prostate cancer risk reduction due to regulatory feedback.
• AVODART remains a significant player in the BPH treatment market with ongoing safety monitoring.

FAQs

What is AVODART used for?

AVODART is used to treat the symptoms of benign prostatic hyperplasia (BPH) and, in some cases, to reduce the risk of acute urinary retention (AUR) and BPH-related surgery.

What were the findings of the REDUCE trial?

The REDUCE trial found that AVODART reduced the overall incidence of prostate cancer but increased the incidence of high-grade prostate cancer (Gleason score 8-10) compared to the placebo group.

Why did GSK withdraw applications for prostate cancer risk reduction?

GSK withdrew applications due to concerns over the clinical significance of reducing low-grade prostate cancer and the increased incidence of high-grade tumors, as well as feedback from regulatory agencies.

What are the common adverse reactions associated with AVODART?

Common adverse reactions include impotence, decreased libido, breast disorders (such as breast enlargement and tenderness), and ejaculation disorders.

Is AVODART still used in the treatment of BPH?

Yes, AVODART remains approved and widely used for the treatment of BPH symptoms and, in some countries, for reducing the risk of AUR and BPH-related surgery.

Sources

1. FDA Label for AVODART: Clinical trials with AVODART as monotherapy or in combination with tamsulosin.
2. Grand View Research: Advertising-based Video On Demand Market Report, 2030.
3. GSK Statement on AVODART: GSK statement on Avodart™ (dutasteride) for prostate cancer risk reduction.
4. GSK Regulatory Update: GSK regulatory update – Avodart (dutasteride).