CLINICAL TRIALS PROFILE FOR TESTOSTERONE ENANTHATE

All Clinical Trials for TESTOSTERONE ENANTHATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00070733 ↗	The Effect of 5-Alpha Reductase on Testosterone in Men	Unknown status	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	2003-08-01	The enzyme 5-alpha reductase is present in small amounts in muscle and converts testosterone to dihydrotestosterone (DHT). Testosterone affects lean body tissue, muscle size, muscle strength, and sexual function in men. This study will evaluate how 5-alpha reductase influences the effects of testosterone in young healthy men.
NCT00161304 ↗	Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency	Completed	Solvay Pharmaceuticals	Phase 2/Phase 3	2003-04-01	The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels.
NCT00161304 ↗	Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency	Completed	Watson Pharmaceuticals	Phase 2/Phase 3	2003-04-01	The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels.
NCT00161304 ↗	Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency	Completed	Leonard S. Marks, M.D.	Phase 2/Phase 3	2003-04-01	The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels.
NCT00004771 ↗	Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease	Completed	Ohio State University	Phase 2	1992-10-01	OBJECTIVES: I. Evaluate the effects of androgen suppression with leuprolide and androgen replacement with testosterone enanthate on muscle strength in men with Kennedy's disease or other motor neuron disease.
NCT00004771 ↗	Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease	Completed	National Center for Research Resources (NCRR)	Phase 2	1992-10-01	OBJECTIVES: I. Evaluate the effects of androgen suppression with leuprolide and androgen replacement with testosterone enanthate on muscle strength in men with Kennedy's disease or other motor neuron disease.
NCT00001079 ↗	A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To test the hypothesis that the predominant accrual of fat rather than lean body mass (LBM) that occurs during treatment of HIV-associated wasting with megestrol acetate may be improved by treatment with megestrol acetate and testosterone enanthate in combination. Body wasting is an increasingly frequent AIDS-defining condition in individuals infected with HIV. Increasing caloric intake fails to consistently restore lean tissue patients with HIV associated weight loss. Megestrol acetate has been shown to stimulate appetite and weight gain in subjects with cancer and in those with HIV associated weight loss. However, the weight gained during treatment with megestrol acetate was predominantly or exclusively fat. An important factor is the preferential increase in body fat seen in both of these studies may have been due to hypogonadism that occurs as a result of treatment with megestrol acetate, a progestational agent. Hypogonadism is associated with an increase in body fat and a decrease in LBM. Concomitant testosterone replacement should substantially increase the amount of LBM accrued during megestrol acetate therapy. This study will determine whether anabolic potential can be realized when caloric intake is increased in the absence of concomitant hypogonadism.

Clinical Trial Conditions for TESTOSTERONE ENANTHATE

Condition Name

Condition Name for TESTOSTERONE ENANTHATE
Intervention	Trials
Hypogonadism	10
Aging	3
Prostate Cancer	3
Sarcopenia	3

Condition MeSH

Condition MeSH for TESTOSTERONE ENANTHATE
Intervention	Trials
Hypogonadism	11
Prostatic Neoplasms	7
Sarcopenia	3
Mobility Limitation	2

Clinical Trial Locations for TESTOSTERONE ENANTHATE

Trials by Country

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Trials by Country for TESTOSTERONE ENANTHATE
Location	Trials
United States	97
Australia	1
Canada	1

Trials by US State

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−

Trials by US State for TESTOSTERONE ENANTHATE
Location	Trials
Texas	12
California	10
Ohio	6
Massachusetts	6
Maryland	5

Clinical Trial Progress for TESTOSTERONE ENANTHATE

Clinical Trial Phase

Clinical Trial Phase for TESTOSTERONE ENANTHATE
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	6
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for TESTOSTERONE ENANTHATE
Clinical Trial Phase	Trials
Completed	24
Recruiting	5
Active, not recruiting	3

Clinical Trial Sponsors for TESTOSTERONE ENANTHATE

Sponsor Name

Sponsor Name for TESTOSTERONE ENANTHATE
Sponsor	Trials
The University of Texas Medical Branch, Galveston	7
Antares Pharma Inc.	5
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	3

Sponsor Type

Sponsor Type for TESTOSTERONE ENANTHATE
Sponsor	Trials
Other	42
Industry	15
NIH	9

Testosterone Enanthate: Clinical Trials, Market Analysis, and Projections

Introduction to Testosterone Enanthate

Testosterone enanthate is a widely used form of testosterone replacement therapy (TRT) known for its efficacy in treating hypogonadism, a condition characterized by low levels of testosterone. This article will delve into the current clinical trials, market analysis, and future projections for testosterone enanthate.

Clinical Trials Update

Study on Adolescent Males

A recent Phase 3/4 clinical trial is underway to investigate the safety, pharmacokinetics (PK), and efficacy of XYOSTED, a form of testosterone replacement therapy, in adolescent males with primary or secondary hypogonadism. This 52-week open-label, multicenter study involves approximately 100 male participants aged 12 to <18 years. The study aims to adjust doses based on weight and targeted Tanner Stage to achieve desired testosterone levels, with evaluations every 3 months to ensure the desired testosterone levels are maintained[1].

Pharmacokinetic Profile of Subcutaneous Testosterone Enanthate

A study published in the SMOA journal focused on the pharmacokinetics, safety, and tolerability of subcutaneous testosterone enanthate (TE) administered via a novel single-use autoinjector system. This open-label, parallel-group study involved 39 men with hypogonadism who received either 50 mg or 100 mg of SC TE weekly. The results showed that both doses achieved normal average concentrations of serum testosterone within a 168-hour dosing interval, demonstrating steady, dose-proportional measures of exposure and good tolerability[4].

Market Analysis

Current Market Size and Growth

The global testosterone replacement therapy market, which includes testosterone enanthate, has seen significant growth in recent years. As of 2023, the market size is estimated to be around $2.01 billion and is projected to grow to $2.07 billion in 2024, with a compound annual growth rate (CAGR) of 2.2% expected to reach $2.26 billion by 2028[5].

Market Segmentation

The testosterone replacement therapy market is segmented based on product type, active ingredient type, and end-user. The injectables segment, which includes testosterone enanthate, is expected to hold the largest share of the market during the forecast period. Testosterone cypionate is another significant segment, expected to grow at the fastest CAGR due to its widespread use and high effectiveness[3].

Geographical and Application Segments

The market is also categorized by geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. In terms of application, the market is divided into medical use and personal use. The medical use segment dominates the market, driven by the increasing prevalence of hypogonadism and the need for effective treatment options[2].

Market Projections

Growth Drivers

Several factors are driving the growth of the testosterone enanthate market:

• Increasing Male Wellness Market: Growing awareness and concern about male health and wellness are driving demand for testosterone replacement therapies.
• Innovations in Delivery Systems: New delivery systems, such as subcutaneous autoinjectors, are making treatment more user-friendly and effective.
• Regulatory Support: Favorable regulatory environments are facilitating the approval and use of new testosterone replacement therapies.
• Globalization of Health Services: The increasing globalization of health services is expanding access to these treatments worldwide[5].

Challenges and Restraints

Despite the growth, the market faces several challenges:

• Infrastructure Issues: In developing nations, inadequate healthcare infrastructure can limit the availability and accessibility of testosterone replacement therapies.
• Strict FDA Regulations: Stringent regulatory requirements can slow down the approval process for new treatments.
• Potential Side Effects: Concerns about side effects and safety risks associated with testosterone replacement therapies can also impact market growth[3].

Key Trends in the Forecast Period

Innovations in Delivery Systems

Advancements in delivery systems, such as the novel single-use autoinjector for subcutaneous testosterone enanthate, are expected to continue. These innovations make treatments more convenient and effective, contributing to market growth[4].

Telemedicine and Remote Monitoring

The integration of telemedicine and remote monitoring is becoming more prevalent, allowing for more personalized and efficient treatment plans. This trend is expected to enhance patient compliance and outcomes[5].

Customized Treatment Plans

The move towards precision medicine and customized treatment plans is another significant trend. This approach ensures that treatments are tailored to individual patient needs, improving efficacy and reducing side effects[5].

Conclusion

Testosterone enanthate remains a crucial component of the testosterone replacement therapy market, driven by its efficacy and the evolving needs of patients with hypogonadism. Ongoing clinical trials and innovations in delivery systems are expected to further enhance its safety and effectiveness. Despite challenges such as regulatory hurdles and infrastructure issues, the market is projected to continue its steady growth.

Key Takeaways

• Clinical Trials: Ongoing studies are focusing on the safety, PK, and efficacy of testosterone enanthate in various populations, including adolescent males.
• Market Growth: The global testosterone replacement therapy market, including testosterone enanthate, is expected to grow steadily, driven by innovations and increasing demand.
• Market Segmentation: The injectables segment, which includes testosterone enanthate, is expected to dominate the market.
• Growth Drivers: Factors such as innovations in delivery systems, regulatory support, and the growing male wellness market are driving growth.
• Challenges: Infrastructure issues, strict regulations, and potential side effects are among the challenges facing the market.

FAQs

What is the current market size of the testosterone replacement therapy market?

The current market size of the testosterone replacement therapy market is estimated to be around $2.01 billion as of 2023[5].

What are the primary segments of the testosterone replacement therapy market?

The market is segmented based on product type (e.g., injectables), active ingredient type (e.g., testosterone enanthate), and end-user (e.g., clinics)[3].

What are the key growth drivers for the testosterone enanthate market?

Key growth drivers include innovations in delivery systems, increasing male wellness market, regulatory support, and the globalization of health services[5].

What challenges does the testosterone enanthate market face?

Challenges include infrastructure issues, strict FDA regulations, and potential side effects and safety risks[3].

How is the market expected to grow in the forecast period?

The market is expected to grow steadily, reaching $2.26 billion by 2028 with a CAGR of 2.2%[5].

Sources

1. 52 Week Study of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents. CTV Veeva.
2. Global Testosterone Enanthate Market Size, Trends and Projections. Market Research Intellect.
3. Testosterone Replacement Therapy Market Size, Forecast 2033. Spherical Insights.
4. Pharmacokinetic Profile of Subcutaneous Testosterone Enanthate. SMOA.
5. Testosterone Replacement Therapy Global Market Report 2024. The Business Research Company.