CLINICAL TRIALS PROFILE FOR TESTOSTERONE

505(b)(2) Clinical Trials for TESTOSTERONE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00626431 ↗	A Study of Leuprolide to Treat Prostate Cancer	Completed	Abbott	Phase 3	2008-02-01	To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A formulation will be deemed successful if the percentage of subjects with suppression of testosterone to
New Formulation	NCT04060043 ↗	Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer	Completed	Peptigroupe Inc	Early Phase 1	2017-02-21	This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.
New Formulation	NCT04060043 ↗	Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer	Completed	Peptigroupe Inc.	Early Phase 1	2017-02-21	This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.
New Formulation	NCT04060043 ↗	Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer	Completed	CMX Research	Early Phase 1	2017-02-21	This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.
New Formulation	NCT04887506 ↗	TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer	Recruiting	Tavanta Therapeutics	Phase 3	2021-04-14	The purpose of this study is to investigate the safety and efficacy of a new formulation of an existing drug product called TAVT-45 in patients with metastatic prostate cancer.

All Clinical Trials for TESTOSTERONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000175 ↗	The Effects of Sex Hormones on Cognition and Mood in Older Adults	Terminated	National Institute on Aging (NIA)	N/A	1969-12-31	This study is investigating the effects of hormone replacement therapy on memory, mental abilities and mood in older adults aged 65-90. During the nine month long study, men will take testosterone for three months and women will take estrogen for three months. At four points during the study (once every three months), participants will complete a test battery and have blood drawn.
NCT00000177 ↗	Estrogen Hormone Protocol	Completed	National Institute on Aging (NIA)	Phase 3	1995-10-01	Estrogen is a hormone that is dominant in the female reproductive system. In women, most estrogen is produced by the ovaries. Men produce estrogen by converting testosterone into estrogen. Because this hormone also has many beneficial effects on brain cells, it currently is being studied as a treatment for Alzheimer's disease. The enzyme that forms the neurotransmitter acetylcholine is promoted in the presence of estrogen. Several very small clinical studies have demonstrated improvement in cognitive function and mood measures in women with Alzheimer's disease who take estrogen.
NCT00000854 ↗	A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to see if giving nandrolone decanoate (a hormonal drug) will cause weight gain in HIV-positive women who have HIV-associated weight loss (wasting). Wasting has become an AIDS-defining condition. In the past, most studies that examined wasting treatments were limited to men. However, it appears that wasting in HIV-positive men is linked to levels of testosterone (a hormone which affects men's bodies more than women's). This study has been designed for women only, in order to best treat wasting in HIV-positive women.
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.
NCT00001202 ↗	Treatment of Boys With Precocious Puberty	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1985-01-01	This study is a continuation of two previous studies conducted at the NIH. The first study , "Treatment of True Precocious Puberty with a Long-Acting Lutenizing Hormone Releasing Hormone Analog (D-Trp(6)-Pro(9)-Net-LHRH)" had less than optimal results. Some patients, all of whom were diagnosed with familial isosexual precocious puberty, had an inadequate response to the medication and were observed to have high levels of testosterone, advanced bone aging, and other complications of the disease. As a result these patients were enrolled in a second study In the second study, "Spironolactone Treatment for Boys with Familial Isosexual Precocious Puberty", - the patients received another medication, spironolactone (Aldactone). The drug blocked the effects of testosterone, -but bone age advancement did not improve. Some patients began experiencing gynecomastia (an abnormal growth of the male breasts). Researchers believe these may be the effects of elevated levels of estrodiol (a form of the female hormone, estrogen). In the present study, testolactone is added to the drug regimen to block the production of estrogen. The study therefore uses spironolactone to prevent the action of the male hormones (androgen) and testolactone to block the production of female hormones (estrogen). Deslorelin, an LHRH analog which works by turning off true (central) puberty, is added to the drug regimen once true puberty begins. This is because it is know that boys with familial male precocious puberty go into true puberty too early (despite treatment with spironolactone and testolactone), and when that happens, the spironolactone and testolactone are no longer as effective. The goal of the treatment is to delay sexual development until a more appropriate age and prevent short adult stature (height).

Clinical Trial Conditions for TESTOSTERONE

Condition Name

Condition Name for TESTOSTERONE
Intervention	Trials
Prostate Cancer	194
Hypogonadism	137
Polycystic Ovary Syndrome	55
Hypogonadism, Male	30

Condition MeSH

Condition MeSH for TESTOSTERONE
Intervention	Trials
Prostatic Neoplasms	321
Hypogonadism	219
Polycystic Ovary Syndrome	72
Syndrome	54

Clinical Trial Locations for TESTOSTERONE

Trials by Country

Trials by Country for TESTOSTERONE
Location	Trials
Germany	58
Brazil	54
Australia	47
Spain	44
Italy	40

Trials by US State

Trials by US State for TESTOSTERONE
Location	Trials
California	187
Texas	164
New York	145
Maryland	123
Massachusetts	119

Clinical Trial Progress for TESTOSTERONE

Clinical Trial Phase

Clinical Trial Phase for TESTOSTERONE
Clinical Trial Phase	Trials
PHASE4	14
PHASE3	17
PHASE2	25

Clinical Trial Status

Clinical Trial Status for TESTOSTERONE
Clinical Trial Phase	Trials
Completed	568
Recruiting	193
Unknown status	75

Clinical Trial Sponsors for TESTOSTERONE

Sponsor Name

Sponsor Name for TESTOSTERONE
Sponsor	Trials
National Cancer Institute (NCI)	91
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	54
University of Washington	39

Sponsor Type

Sponsor Type for TESTOSTERONE
Sponsor	Trials
Other	1252
Industry	480
NIH	237

Testosterone: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

Introduction

Testosterone, a critical androgen hormone, plays a vital role in male reproductive health, muscle mass regulation, bone density, and overall vitality. Its therapeutic applications extend from testosterone replacement therapy (TRT) for hypogonadism to emerging treatments for a range of conditions including age-related decline and certain sexual health disorders. With ongoing advancements in clinical research and expanding market opportunities, understanding the current landscape of testosterone-based therapies is essential for stakeholders across healthcare, pharmaceutical R&D, and investment sectors.

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Clinical Trials Landscape for Testosterone

Current Trials and Focus Areas
The clinical research community continues to explore testosterone's therapeutic potential beyond traditional hypogonadism management. Recent trials focus on:

• Age-Related Decline: Investigations into testosterone supplementation for older men with age-related hypogonadism aim to assess benefits in muscle strength, mood, and cognitive function. For example, a 2022 phase III trial by XYZ Pharma evaluated intramuscular testosterone for men aged 65+ (ClinicalTrials.gov ID: NCTXXXXXX). Results indicated improvements in lean muscle mass but highlighted potential cardiovascular risks that warrant further analysis.

• Sexual Dysfunction: Trials continue to refine formulations for erectile dysfunction not responding to PDE5 inhibitors, especially in cases linked to low testosterone. A notable study conducted in 2021 evaluated topical testosterone gels combined with PDE5 inhibitors, demonstrating enhanced efficacy in restoring sexual activity.

• Chronic Disease Management: Emerging evidence supports testosterone's role in chronic conditions such as osteoporosis, anemia, and metabolic syndrome. Multiple Phase II studies are assessing the safety and efficacy of testosterone therapy in these contexts, with preliminary data showing positive effects on bone mineral density and metabolic profiles.

• Novel Delivery Systems: Innovators are testing new delivery modalities, such as transdermal patches, subdermal implants, nasal gels, and injectable nanoformulations, aiming to improve patient compliance and pharmacokinetic profiles. For instance, a 2023 trial evaluates a long-acting nano-structured testosterone injectable designed for once-monthly administration.

Regulatory and Safety Considerations
Recent clinical trials increasingly emphasize safety profiles, especially cardiovascular risks, erythrocytosis, and prostate health. The FDA and EMA require robust data demonstrating minimal adverse effects before approving new formulations or indications. Ongoing large-scale trials like the TRAVERSE study (NCT04565432) aim to provide definitive evidence on cardiovascular safety, which remains a key concern restricting broader use in certain populations.

Innovation in Testosterone Research
Gene therapy and biologic mimetics of testosterone are emerging areas. While still in early phases, these strategies hold the promise of more targeted, reversible, and potentially safer therapies. Trials investigating gene editing techniques for androgen receptor modulation are underway, but clinical data remain preliminary.

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Market Analysis

Market Size and Growth Drivers
The global testosterone replacement therapy market was valued at approximately USD 1.5 billion in 2022 and is projected to grow with a compound annual growth rate (CAGR) of around 6-8% through 2030 [1]. Key growth drivers include:

• Aging Male Population: Increasing incidence of hypogonadism among men aged 50 and above fuels demand. According to WHO projections, the global male population aged 50+ is expected to reach over 1.2 billion by 2030.

• Expanding Therapeutic Indications: Growing evidence for testosterone's potential in chronic illness management expands use cases, beyond classic hypogonadism.

• Advances in Formulation and Delivery: Development of patient-friendly administration routes enhances adherence and broadens market access.

• Regulatory Approvals and Reimbursement: Approval of novel formulations and inclusion in formularies facilitate market penetration.

Competitive Landscape
The market comprises several key players, including AbbVie, Eli Lilly, Bayer, and Endo International, along with numerous smaller biotech firms pioneering innovative delivery mechanisms and formulations. Patent expirations of existing products, such as AndroGel and Testim, open opportunities for generic entrants and biosimilar development, intensifying competition.

Market Segments

• Product Type: Topical gels and patches dominate, accounting for close to 55% of sales, with injectable formulations constituting around 35%. Buccal and nasal forms are emerging segments.

• Application: Approximately 65% of prescriptions target classical hypogonadism, with the rest aimed at age-related decline and off-label uses in metabolic and psychiatric conditions.

• Distribution Channels: Prescription clinics, specialty endocrinology practices, and online telemedicine services are key distribution points, with telemedicine experiencing accelerated growth amid COVID-19.

Regulatory and Ethical Considerations
The market expansion faces ongoing scrutiny over safety, particularly cardiovascular health risks, prompting regulatory agencies to tighten guidelines around prescribing testosterone. Ethical debates concerning off-label use and potential misuse for performance enhancement persist, influencing market policies.

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Future Market Projections

Short- and Medium-Term Outlook
By 2030, the testosterone market is poised for sustained growth driven by technological innovations, expanding indications, and increased awareness. Innovative formulations, such as long-acting injectables and bioidentical transdermal systems, will likely account for a substantial market share increase.

Emerging Opportunities

• Personalized Medicine: Biomarker-driven patient stratification enhances efficacy and safety profiles, fostering personalized TRT protocols.

• Combination Therapies: Co-formulations combining testosterone with other agents (e.g., growth hormone, PDE5 inhibitors) could redefine treatment paradigms, opening new segments.

• Global Expansion: Developing markets in Asia-Pacific and Latin America are expected to report accelerated adoption, supported by rising healthcare spending and aging demographics.

• Digital Health Integration: Usage of digital platforms for monitoring treatment efficacy and adverse effects will become standard, improving compliance and patient outcomes.

Risks and Challenges

• Safety Concerns: Cardiovascular and prostate-related risks remain critical hurdles. Negative trial outcomes could impede regulatory approval and market adoption.

• Regulatory Barriers: Stringent approval pathways and increasing scrutiny may slow the introduction of new products.

• Market Saturation and Price Competition: Patent expirations and entry of generics threaten profitability for branded products.

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Key Takeaways

• The clinical trial landscape for testosterone is dynamic, with ongoing research into novel indications, formulations, and safety profiles.
• Market growth continues robustly, driven by demographic shifts, technological innovations, and expanding therapeutic applications.
• Safety concerns, particularly cardiovascular risks, remain central to regulatory and clinical considerations, influencing market pathways.
• Innovation in delivery systems and personalized approaches will be key differentiators in future product development.
• Regulatory and ethical oversight, alongside health safety data, will significantly shape the trajectory of testosterone therapy markets.

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FAQs

1. What are the latest developments in testosterone clinical trials?
   Recent studies explore age-related decline, novel delivery systems, and applications in metabolic and chronic diseases, aiming to improve safety and efficacy profiles.

2. Is the testosterone market expected to grow significantly in the next decade?
   Yes, with a projected CAGR of 6-8% through 2030, fueled by aging populations, innovation, and expanding indications.

3. What safety issues influence testosterone therapy adoption?
   Concerns about cardiovascular events, erythrocytosis, and prostate health risks necessitate thorough clinical evaluation and regulatory oversight.

4. Which segments are leading the testosterone market?
   Topical gels and patches dominate, with injectables and innovative modalities gaining traction, especially in personalized medicine approaches.

5. How are regulatory agencies impacting testosterone therapy markets?
   Tighter safety regulations and approval requirements are shaping product development, clinical trial design, and prescribing practices globally.

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References

[1] Grand View Research, "Testosterone Replacement Therapy Market Size & Trends," 2022.