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).
NCT00001951 ↗	Hormone Replacement in Young Women With Premature Ovarian Failure	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1999-12-01	The human ovary produces male sex hormones (androgen) and female sex hormones (estrogen). Currently, androgen is not included in hormone replacement therapy for women with premature ovarian failure. Present hormone replacement therapy (HRT) was designed to treat women who experience ovarian failure at menopause (around the age of 50). However, 1% of women will experience premature failure of the ovaries before the age of 40. There have been no studies conducted to determine proper hormone replacement therapies for these younger women. Some research suggests that the usual menopausal hormone replacement therapy is not adequate to protect young women with premature ovarian failure from developing osteoporosis. Women with premature ovarian failure have abnormally low levels of androgens circulating in their blood. This may contribute to the increase risk for osteoporosis. This study will compare two treatment plans for women with premature ovarian failure. Treatment plan one will be physiological estrogen hormone replacement. Treatment plan two will be physiological estrogen hormone replacement plus androgen. The study will attempt to determine which plan is more beneficial to women in relation to osteoporosis and heart disease. The hormones will be contained in patches and given by placing the patches against the patient's skin. The patches were designed to deliver the same amount of hormone as would be normally produced by the ovary in young women. The success of the treatment will be measured by periodically checking the density of patient's bone in the leg (femoral neck bone) . Researchers will take an initial (baseline) measurement of bone density before beginning treatment and then once a year, for 3 additional years, during treatment. The study will also consider bone density of the spine, bone turnover, heart disease risk factors, and psychological state.

Clinical Trial Conditions for testosterone

Condition Name

Condition Name for testosterone
Intervention	Trials
Prostate Cancer	195
Hypogonadism	137
Polycystic Ovary Syndrome	55
Hypogonadism, Male	33

Condition MeSH

Condition MeSH for testosterone
Intervention	Trials
Prostatic Neoplasms	324
Hypogonadism	219
Polycystic Ovary Syndrome	74
Syndrome	54

Clinical Trial Locations for testosterone

Trials by Country

Trials by Country for testosterone
Location	Trials
Germany	58
Brazil	55
Australia	47
Spain	45
Italy	40

Trials by US State

Trials by US State for testosterone
Location	Trials
California	188
Texas	165
New York	146
Maryland	123
Florida	120

Clinical Trial Progress for testosterone

Clinical Trial Phase

Clinical Trial Phase for testosterone
Clinical Trial Phase	Trials
PHASE4	16
PHASE3	17
PHASE2	29

Clinical Trial Status

Clinical Trial Status for testosterone
Clinical Trial Phase	Trials
Completed	570
Recruiting	195
Terminated	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	1260
Industry	481
NIH	237

Testosterone clinical trials update, market analysis and 2026–2035 projections by formulation (gels, injections, implants, oral)

Last updated: May 21, 2026

Executive summary
Testosterone therapy remains a large, mature but still growing category across male hypogonadism and related conditions, with demand supported by long-running diagnosis expansion in aging male populations and ongoing label and evidence efforts. Market trajectory is being shaped less by “new drug” innovation and more by formulation upgrades, payer-driven substitution among delivery systems, and pipeline activity around improved pharmacokinetics, reduced inter-dose fluctuations, and alternative delivery routes. Near-term growth is most exposed to biologic and rare-condition headwinds only at the margin; the dominant risks are pricing pressure, patent/transition dynamics in specific products and geographies, and regulatory scrutiny tied to cardiovascular, prostate, and fertility safety evidence.
Source coverage: no product-specific trial registry pull, FDA status scrape, or Orange Book extraction was provided; the analysis below is therefore limited to the highest-confidence, category-level update and projection framework that does not depend on a single branded testosterone product.

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What clinical trials are testing testosterone for hypogonadism and related indications?

Featured snippet answer: Current trial activity in testosterone programs clusters around (1) long-acting and steady-exposure formulations, (2) new dosing regimens that reduce peaks and troughs, and (3) endpoints that support “safety with monitoring” narratives (cardiovascular risk, hematocrit, fertility parameters) and improve symptom control.

Trial themes that dominate testosterone studies

Across the category, sponsors typically focus on:

• Steady testosterone exposure: less variability to improve symptom scores and reduce adverse events tied to high peaks (eg, erythrocytosis risk proxies).
• Dosing frequency reduction: transition from daily to weekly or longer schedules, and from injections to gels with alternative penetration or adhesion technologies.
• Patient-reported outcomes: improvement in libido, erectile function measures, energy/fatigue scales, and quality-of-life domains used in androgen deficiency studies.
• Safety monitoring endpoints: hematocrit changes, PSA trajectories, cardiovascular event adjudication, and fertility-related biomarkers where relevant.
• Subpopulation targeting: men with age-related hypogonadism, men previously treated, and men with metabolic comorbidities, where endpoints are often stratified.

What endpoints regulators and payers look for

Even when the mechanism is unchanged, developers structure programs to support:

• Normalization targets: proportion of patients reaching and maintaining testosterone within a predefined reference range.
• Tolerability: incidence of treatment-emergent adverse events and dose interruptions.
• Laboratory safety: hematocrit response and “management thresholds.”
• Persistence and adherence: persistence on therapy and reasons for discontinuation, which drive real-world utilization more than marginal efficacy deltas.

Where trials are most likely to affect label scope

Category-level label expansion is usually incremental, driven by:

• Specific dosing regimen claims
• Evidence packages for additional formulations
• Updated safety monitoring language and risk mitigation

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Which testosterone formulations are in late-stage clinical development (gels, injections, patches, implants, oral)?

Featured snippet answer: Late-stage efforts concentrate on long-acting depot or improved transdermal systems designed to smooth exposure and simplify adherence. Oral androgen approaches are rarer in development cycles due to GI tolerability and hepatic exposure considerations, so the biggest commercial “pipeline lift” tends to come from injection or transdermal delivery systems.

Delivery system-by-delivery system: typical development priorities

Transdermal (gels/solutions/patch-like formats)

• Improved skin penetration consistency
• Reduced dose variability across patients and application sites
• Better adherence and switching controls for safety monitoring

Long-acting injections

• Extended dosing intervals
• Reduced peak-related adverse outcomes
• Administration training simplification through prefilled formats

Implants/depots

• Lower dosing frequency
• Longer time to discontinuation, which increases the value of predictable pharmacokinetics

Oral and alternative routes

• If pursued, programs typically target improved tolerability and reduced hepatic risk signals

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How many randomized trials and participants support testosterone efficacy and safety for hypogonadism?

Featured snippet answer: Testosterone has one of the largest evidence bases among endocrine replacement therapies, with long-term randomized and observational data. Current development cycles often rely on smaller “comparability-style” trials to support pharmacokinetic and exposure matching for reformulations and delivery system changes.

What “trial count” means for testosterone now

For mature hormones, “new evidence” tends to come in three forms:

1. Comparative pharmacokinetic trials (formulation-to-reference exposure)
2. Randomized efficacy trials using standardized symptom and lab endpoints
3. Safety extension studies and registry-linked observational evidence

For market planning, the practical implication is that trials usually do not reset the category’s clinical positioning. Instead, they support switchability and coverage decisions between formulations.

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When do testosterone products lose exclusivity, and what does that mean for generics and biosimilar-style competition?

Featured snippet answer: Testosterone is dominated by mature products where exclusivity has largely progressed; competition is driven by formulation-specific patent estates and regulatory exclusivity windows rather than one “single future break.” Net exposure is therefore fragmented by product and country.

Exclusivity and competition mechanics by product class

• Gels and solutions: frequently face abbreviated regulatory pathways once formulation patents expire; entry risk is sensitive to manufacturing-process and composition-of-matter coverage.
• Injectables: competition can emerge after device/container, ester composition, and manufacturing-process patents end.
• Implants: fewer entries in some markets due to device and procedural components.

Litigation and settlement patterns that matter

In mature categories, disputes often focus on:

• Patent infringement for specific formulation, manufacturing process, or method-of-use
• Carve-outs tied to dosing regimen claims
• Launch timing tied to settlement schedules

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What is the Orange Book status of testosterone products in the US?

Featured snippet answer: Testosterone products are widely present on the FDA Drug Product List and many testosterone active ingredients appear across multiple NDAs/ANDAs. However, “Orange Book status” is product-specific and requires exact mapping from a named brand or NDA number to listed patents.

How that impacts market projections

• Broadly available actives compress price growth.
• Product-specific listed patents extend protection in practice for certain strengths, delivery systems, or device components.
• Real-world substitution tends to follow payer formularies and administration practicality more than small clinical differences.

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What patent estate strength covers testosterone delivery systems and dosing regimens?

Featured snippet answer: Patent estates are usually fragmented across formulation composition, manufacturing process, delivery device/container, and sometimes method-of-use or dosing regimen claims. For market timing, the “strong” estate tends to be the one that blocks generic formulation similarity while maintaining regulatory interchangeability.

Where patents typically concentrate

• Composition-of-matter or formulation for gels (excipients, penetration aids, film formers)
• Manufacturing process and controls that affect particle distribution or stability
• Device and delivery system: pumps, applicators, injection systems
• Method-of-use: sometimes tied to titration or monitoring protocols rather than core hormone effect

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What generic entry risks exist for testosterone, and which claims are most vulnerable?

Featured snippet answer: Generic entry risk is highest when the listed patents are primarily formulation-specific but the intended product can be developed with bioequivalent exposure and alternative manufacturing. Vulnerability is lower when device and method claims are strongly protected.

Practical generic triggers

• Bioequivalence feasibility to the reference
• Ability to design around composition and manufacturing patents
• Payer acceptance driven by predictable dosing and reduced monitoring burden

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How does testosterone market demand vary by geography and healthcare system structure?

Featured snippet answer: Demand is shaped by diagnosis rates, endocrine and urology prescribing practices, reimbursement rules, and the administrative and monitoring burden of therapy. Systems that reduce friction for specialist initiation can sustain growth.

Key regional drivers

US

• Mature base, payer-driven switching among gels, injectables, and alternatives
• Strong influence of safety messaging and monitoring adherence programs

EU (selected markets)

• Similar patterns with increased emphasis on prescribing guidelines and safety documentation

Japan and other developed markets

• Utilization influenced by guideline adoption, product availability, and reimbursement coverage

Emerging markets

• Lower baseline but rising endocrine awareness; growth can be volume-led with pricing sensitivity

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What is the testosterone market size and growth outlook through 2035?

Featured snippet answer: The testosterone category is expected to grow at a mid-single-digit to low-double-digit CAGR range globally over the longer horizon depending on diagnosis expansion and formulation replacement dynamics, with pricing pressure offset by adoption of “more convenient” delivery systems and adherence improvements.

Market drivers

• Epidemiology: aging male population and increased recognition of androgen deficiency syndromes
• Therapy adoption: adherence improvements via delivery system engineering
• Clinical evidence expansion: safety monitoring frameworks that reduce perceived risk
• Product lifecycle: replacements from daily to less frequent dosing formats

Market headwinds

• Safety scrutiny tied to cardiovascular and prostate risk management narratives
• Payer constraints: step edits, prior authorization, and hematocrit monitoring documentation
• Patent and regulatory fragmentation: competition timing by country and product type

Projection framework used for business planning

Because specific branded-product trial and exclusivity datasets were not provided, a robust projection uses:

• Number of treated patients (diagnosis and persistence)
• Average revenue per patient by formulation mix
• Competitive pressure and reimbursement changes at product level

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How do formulation mix shifts change revenue projections for testosterone?

Featured snippet answer: Shifts from older daily gels or higher-frequency regimens to improved, convenient delivery formats tend to support unit revenue stability even under generic pricing pressure because adherence and payer policies favor predictable exposure and ease of use.

Mix scenarios that move projections

• Scenario A (adherence-led): higher persistence for long-acting formats stabilizes revenue per patient.
• Scenario B (pricing-led): aggressive generics and pharmacy substitution compress average net price.
• Scenario C (monitoring-led): stricter documentation requirements increase administrative friction, reducing initiation in lower-access settings.

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Which companies commercialize testosterone and what is the competitive landscape?

Featured snippet answer: The competitive set spans originator manufacturers and multiple generic entrants across US and international markets. Branding and device differentiation are often the key determinants of share rather than molecule-level differentiation.

How competition plays out operationally

• Formulary inclusion: a major share driver for payers and pharmacy benefit managers.
• Switching policies: state and plan-level rules influence how quickly patients move between formulations.
• Real-world adherence: pump reliability, applicator ergonomics, and injection administration support change persistence.

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What testosterone clinical programs could create meaningful differentiated value?

Featured snippet answer: Differentiation is most likely from (1) improved pharmacokinetics and steady-state exposure, (2) simplified dosing with predictable monitoring burdens, and (3) data packages that support payer-friendly safety narratives.

High-impact program attributes

• Clear titration strategy with target achievement rates
• Reduced variability across application sites or injection technique
• Safety monitoring that reduces hematocrit escalation rates or management interventions

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Key takeaways

• Testosterone market growth depends more on formulation substitution, persistence, and payer policy than on molecule-level novelty.
• Clinical trials mainly support steady-exposure delivery, adherence, and safety monitoring endpoints.
• Exclusivity and generic entry risks are product- and country-specific; market exposure is fragmented across formulation patent estates and regulatory pathways.
• 2035 growth is likely mid-single-digit to low-double-digit globally, with pricing pressure offset by mix shifts toward more convenient delivery formats and expanded diagnosis.

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FAQs

1. Which testosterone delivery system usually has the best adherence profile in real-world practice?
2. How do hematocrit monitoring requirements affect persistence and payer coverage for testosterone therapy?
3. Do cardiovascular outcomes trials change testosterone prescribing patterns for hypogonadism?
4. What are the main drivers of price compression for testosterone gels in the US?
5. How do switching policies between testosterone formulations affect patient discontinuation rates?

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References

No sources were provided in the prompt, and no extractable FDA/Orange Book, ClinicalTrials.gov, or market-figure inputs were included.