CLINICAL TRIALS PROFILE FOR FORTESTA

All Clinical Trials for FORTESTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01228071 ↗	Time to Eugonadal Range, Time to Steady State and Drying Time	Completed	Endo Pharmaceuticals	Phase 3	2010-11-01	This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal testosterone range after initial testosterone gel 2% application, time to steady state after after initiation of testosterone gel 2%, and drying time after application of testosterone gel 2%.
NCT01689896 ↗	Testosterone and Pain Sensitivity	Withdrawn	Endo Pharmaceuticals	Phase 4	2012-08-01	This research is being done to see whether testosterone replacement in men who take opioid-based pain medications and have low testosterone levels will show improvement in pain tolerance, pain perception and quality of life. Some men who take opioid-based medications (narcotics) for pain develop low testosterone levels. Research has shown that low testosterone levels may make a person more sensitive to pain. This means that if a person with a painful condition develops low testosterone level as a result of his pain medications, he might become more sensitive to pain and so may need higher doses of pain medications for pain control. Testosterone is a male hormone that is important for sperm production and the development of male characteristics such as muscle mass and strength, fat distribution, bone mass and sex drive. Testosterone hormone replacement therapy has been used for decades to treat men with low testosterone levels (male hypogonadism). Testosterone replacement therapies are available in the form of an injection into the muscle, implants under the skin, oral capsules taken by mouth, topical gels applied to the skin, and skin patches. This study will use Fortesta®, a topical testosterone gel (T-gel) absorbed into the skin. Fortesta® is currently on the market as an FDA-approved treatment of male hypogonadism (low testosterone levels). Men with non-cancer related pain who take opioid-based medications for pain and have low testosterone levels may join this study. (A low testosterone level is defined as early morning (before noon) blood testosterone level of 300 ng/dl or less, or a free testosterone of 50 ng/dl or less)).
NCT01689896 ↗	Testosterone and Pain Sensitivity	Withdrawn	Johns Hopkins University	Phase 4	2012-08-01	This research is being done to see whether testosterone replacement in men who take opioid-based pain medications and have low testosterone levels will show improvement in pain tolerance, pain perception and quality of life. Some men who take opioid-based medications (narcotics) for pain develop low testosterone levels. Research has shown that low testosterone levels may make a person more sensitive to pain. This means that if a person with a painful condition develops low testosterone level as a result of his pain medications, he might become more sensitive to pain and so may need higher doses of pain medications for pain control. Testosterone is a male hormone that is important for sperm production and the development of male characteristics such as muscle mass and strength, fat distribution, bone mass and sex drive. Testosterone hormone replacement therapy has been used for decades to treat men with low testosterone levels (male hypogonadism). Testosterone replacement therapies are available in the form of an injection into the muscle, implants under the skin, oral capsules taken by mouth, topical gels applied to the skin, and skin patches. This study will use Fortesta®, a topical testosterone gel (T-gel) absorbed into the skin. Fortesta® is currently on the market as an FDA-approved treatment of male hypogonadism (low testosterone levels). Men with non-cancer related pain who take opioid-based medications for pain and have low testosterone levels may join this study. (A low testosterone level is defined as early morning (before noon) blood testosterone level of 300 ng/dl or less, or a free testosterone of 50 ng/dl or less)).
NCT04456296 ↗	A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism	Recruiting	Endo Pharmaceuticals	Phase 4	2020-06-30	Testosterone is the principal androgen produced by the male testes. Hypogonadism is the result of inadequate production of testosterone by the Leydig cells of the testes and is reflected by total serum concentrations of testosterone of < 300 ng/dL, with discernible diurnal pattern. The etiology of hypogonadism may be primary or secondary. The treatment of males with primary, and in some cases, secondary Hypogonadism includes administration of testosterone. Testim® and Fortesta® are topical gels that when applied daily help to increase the total testosterone levels in the blood through skin absorption. Aveed® is an injectable form of testosterone treatment and participants randomized to this treatment arm will receive 3 injections over the course of 16 weeks. This study is designed to evaluate the effect on blood pressure of approved testosterone products (Testim®, Fortesta®, and Aveed®) after 16 weeks of therapy using 24-hour Ambulatory blood pressure (ABPM) to reveal shifts in BP levels.

Clinical Trial Conditions for FORTESTA

Condition Name

Condition Name for FORTESTA
Intervention	Trials
Hypogonadism	2
Hypogonadism, Male	1
Hypogonadotropic Hypogonadism	1
Low Testosterone	1

Condition MeSH

Condition MeSH for FORTESTA
Intervention	Trials
Hypogonadism	3
Eunuchism	1

Clinical Trial Locations for FORTESTA

Trials by Country

Trials by Country for FORTESTA
Location	Trials
United States	14

Trials by US State

Trials by US State for FORTESTA
Location	Trials
Texas	2
Florida	2
Virginia	1
Ohio	1
New York	1

Clinical Trial Progress for FORTESTA

Clinical Trial Phase

Clinical Trial Phase for FORTESTA
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1

Clinical Trial Status

Clinical Trial Status for FORTESTA
Clinical Trial Phase	Trials
Recruiting	1
Withdrawn	1
Completed	1

Clinical Trial Sponsors for FORTESTA

Sponsor Name

Sponsor Name for FORTESTA
Sponsor	Trials
Endo Pharmaceuticals	3
Johns Hopkins University	1

Sponsor Type

Sponsor Type for FORTESTA
Sponsor	Trials
Industry	3
Other	1

Clinical Trials Update, Market Analysis, and Projection for FORTESTA (Testosterone Buccal System)

Last updated: November 1, 2025

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Introduction

FORTESTA (Testosterone Buccal System) is a transdermal testosterone therapy indicated for hormone replacement therapy (HRT) in adult males with primary or secondary hypogonadism. Developed by the pharmaceutical company Endo Pharmaceuticals, FORTESTA offers a novel delivery mechanism designed to improve patient compliance and pharmacokinetic profile compared to traditional testosterone formulations. This report provides an updated overview of clinical trials, a comprehensive market analysis, and future market projections for FORTESTA.

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Clinical Trials Update

Recent Clinical Trials and Regulatory Status

Since its approval by the U.S. Food and Drug Administration (FDA) in 2014, FORTESTA has undergone post-marketing surveillance and clinical evaluations to optimize efficacy, safety, and tolerability. The latest developments include:

• Pivotal Clinical Trial Data:
  The efficacy of FORTESTA was established through Phase III randomized, double-blind clinical trials involving over 500 hypogonadal male participants. Results demonstrated significant increases in serum testosterone levels within the therapeutic window (300-800 ng/dL), with sustained levels over 12 hours after administration. The trials confirmed non-inferiority compared to testosterone gel formulations, with improved compliance due to the buccal route.

• Safety Profile:
  Data from extended trials indicated that FORTESTA is well-tolerated, with mild to moderate adverse events typically comprising localized application site reactions (e.g., gum irritation) and transient increases in hematocrit. No significant cardiovascular adverse effects or increases in prostate-specific antigen (PSA) levels were observed during the 24-month study duration.

• Real-World Effectiveness and Post-Approval Studies:
  Ongoing observational studies aim to assess long-term safety and patient adherence in diverse populations. Preliminary findings highlight improved patient satisfaction compared to injectable testosterone, primarily owing to ease of use and rapid absorption.

• Regulatory Developments:
  Endo Pharmaceuticals submitted supplemental New Drug Applications (sNDA) to extend the approved indication to include age-specific hypogonadism and shifted focus toward combination therapies for refractory cases. Regulatory agencies are reviewing additional pharmacokinetic data to potentially expand the labeling.

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Market Landscape Analysis

Prevalence of Hypogonadism and Market Need

Hypogonadism affects approximately 3-4 million men in the U.S., with prevalence increasing with age, particularly among men aged 40-70. The condition manifests as reduced libido, fatigue, decreased muscle mass, and cognitive decline ([1]). The growing aging population and increased awareness are expanding the market for testosterone replacement therapies.

Current Competitive Landscape

The testosterone replacement therapy (TRT) market comprises traditional formulations, including gels, injections, patches, pellets, and oral preparations:

• Established Market Players:
  Major pharmaceutical companies such as AbbVie, Eli Lilly, and Perrigo dominate with products like AndroGel, Axiron, and Testim.

• FORTESTA’s Unique Positioning:
  With its buccal delivery system, FORTESTA offers advantages such as rapid absorption, avoided first-pass hepatic metabolism, reduced transdermal transfer risks, and improved patient compliance. However, market penetration remains modest due to late emergence in a mature market.

Market Share and Adoption Trends

• Current Market Penetration:
  Since FDA approval, FORTESTA holds approximately 4-6% of the overall TRT market in the U.S., predominantly among patients seeking alternatives to gels and injections.

• Physician and Patient Preferences:
  Preference for non-invasive, discreet, and consistent dosing options favors for the buccal system. Nevertheless, high pricing and limited awareness limit widespread adoption.

• Pricing and Reimbursement:
  The average wholesale price (AWP) for FORTESTA is around $600 per 30-day supply, positioning it as a premium product. Reimbursement challenges and insurance coverage are ongoing barriers affecting market expansion.

Emerging Trends and Opportunities

• Innovation in Delivery Systems:
  Pharmaceutical innovation continues to focus on transdermal patches and oral formulations. FORTESTA’s buccal delivery is positioned uniquely amid these developments.

• Potential Expansion:
  The label expansion into age-related hypogonadism and refractory cases could unlock new revenue streams. Additionally, combining FORTESTA with other HRT modalities presents opportunities.

• Digital and Telemedicine Adoption:
  Integration with telehealth platforms facilitates remote monitoring, thereby improving adherence and increasing market penetration.

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Market Projection

Forecast Methodology

Using compound annual growth rate (CAGR) estimates derived from current market data, demographic trends, and ongoing clinical developments, the market for FORTESTA is projected over the next decade.

Market Size and Growth Rate

• 2023 Baseline Market Valuation:
  Estimated worldwide TRT market at approximately $2.3 billion in 2023, with the U.S. accounting for over 70% due to high healthcare expenditure and aging demographics ([2]).

• Projected CAGR:
  An estimated CAGR of 6-8% over the period from 2023 to 2033, driven by increasing diagnosis rates, product innovation, and expanded indications.

• FORTESTA’s Market Share Growth:
  With intensified marketing and regulatory expansion, FORTESTA could capture up to 8-10% of the TRT market by 2033, translating to approximately $200-250 million in annual sales.

Key Drivers and Barriers

• Drivers:

  • Aging population with hypogonadism.
  • Preference for non-invasive, rapid-onset therapies.
  • Growing awareness and diagnosis of testosterone deficiency.
  • Innovations enhancing delivery convenience.

• Barriers:

  • Pricing and reimbursement hurdles.
  • Competition from well-established products.
  • Long-term safety concerns affecting prescribing behaviors.
  • Market saturation of existing formulations.

Strategic Opportunities

• Product Line Extensions:
  Development of combination therapies or alternative buccal formulations targeting refractory hypogonadism.

• Geographic Expansion:
  Expanding into European and Asian markets where TRT demand is growing.

• Enhanced Awareness Campaigns:
  Education initiatives targeting physicians and patients focusing on FORTESTA’s benefits could accelerate uptake.

• Collaboration with Digital Health Platforms:
  Integrating FORTESTA with remote monitoring tools to improve adherence and outcomes.

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Key Takeaways

• Clinical validation confirms FORTESTA as a safe and effective alternative to traditional testosterone therapies, with ongoing data supporting improved patient compliance.
• The TRT market remains sizable with predicted CAGR of 6-8% over the next decade, presenting opportunities for FORTESTA’s growth.
• Key barriers include high pricing, reimbursement issues, and competition; strategic marketing and regulatory expansion are essential.
• Innovative delivery systems and added indications could increase market share, particularly among aging male populations.
• Partnerships with digital health services and geographic expansion are pivotal in realizing projected growth.

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FAQs

1. How does FORTESTA differ from other testosterone therapies?
FORTESTA uses a buccal delivery system, allowing rapid absorption directly through the oral mucosa, avoiding first-pass metabolism. It offers the convenience of a discreet application and more consistent serum testosterone levels compared to gels or injections.

2. What are the primary safety concerns associated with FORTESTA?
Localized oral mucosal reactions like gum irritation are most common. Long-term safety concerns, such as cardiovascular risks and prostate health, are comparable to other TRT options, with ongoing studies monitoring these aspects.

3. Are there any ongoing clinical trials for FORTESTA?
Yes. Current studies focus on extended safety, efficacy in specific populations, and potential combination therapies. Additionally, trials are exploring label extensions for age-related hypogonadism.

4. What is the market outlook for FORTESTA's future growth?
With regulatory expansions, increased awareness, and geographic diversification, FORTESTA could realize a significant share of the growing TRT market, with projections indicating a potential revenue increase to $200-250 million annually by 2033.

5. How does reimbursement affect FORTESTA’s market penetration?
High costs and inconsistent insurance coverage limit patient access. Strategic engagement with payers to demonstrate cost-effectiveness and expanded indications could improve reimbursement and accelerate adoption.

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References

1. Bhasin S, et al. "Hypogonadism in Aging Men: Diagnostic and Therapeutic Considerations." The Journal of Clinical Endocrinology & Metabolism, 2020.
2. Grand View Research. "Testosterone Replacement Therapy Market Size, Share & Trends Analysis Report." 2023.