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Last Updated: March 17, 2025

CLINICAL TRIALS PROFILE FOR TESTOSTERONE PROPIONATE


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All Clinical Trials for TESTOSTERONE PROPIONATE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT04865562 ↗ Hormones and Decision Making Completed University of Texas at Austin Phase 4 2015-03-01 An investigation of the neuropsychological processes underlying ethical decision making.
NCT02361190 ↗ Effects of Fast Acting Testosterone Nasal Spray on Anxiety Completed University of Texas at Austin N/A 2015-02-01 The proposed study will test the effects of a fast-acting testosterone nasal spray on the fear reactions of young men to two distinct anxiety challenges (social and nonsocial) using a double-blind randomized experimental design.
NCT01122342 ↗ Vaginal Testosterone Cream For Atrophic Vaginitis in Women Taking Aromatase Inhibitors for Breast Cancer. Suspended University of Vermont Phase 1/Phase 2 2006-12-01 Atrophic vaginitis is a condition in which the skin lining of the vagina and labia becomes thin and symptoms develop including vaginal itching, vaginal discomfort and dyspareunia. These can significantly affect women's comfort, sexuality and quality of life. Treatment for this condition includes estrogen given in pill form, commonly known as hormone replacement therapy and local estrogen treatments, such as vaginal estrogen creams and topical vaginal lubricants. Unfortunately, systemic estrogen is contraindicated in many women with breast cancer. Some providers also feel that women who are taking aromatase inhibitors for their breast cancer should also not use local estrogens as several small studies suggest that these treatments might effect estrogen levels and thus might change how effective the aromatase inhibitors are. If these women choose not to use any form of estrogen therapy there symptoms may not be well controlled with other treatments. The investigators hypothesize that a vaginal testosterone cream might be a safe and effective alternative treatment for these women. This small study is intended to test the hypothesis that testosterone cream will not increase estrogen (estradiol) levels and that it will improve the symptoms of atrophic vaginitis including vaginal dryness, vaginal itching and pain with intercourse. The investigators will enroll women in the trial who are taking an aromatase inhibitor and have the symptoms mentioned above. They will receive a testosterone cream which will be applied vaginally once a day for 28 days. If good results are found with a prespecified dose of testosterone, a lower dose will be tested in the next group of women enrolled.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for TESTOSTERONE PROPIONATE

Condition Name

11110-0.100.10.20.30.40.50.60.70.80.911.1AnxietyBreast NeoplasmsDyspareuniaDyssocial Behavior[disabled in preview]
Condition Name for TESTOSTERONE PROPIONATE
Intervention Trials
Anxiety 1
Breast Neoplasms 1
Dyspareunia 1
Dyssocial Behavior 1
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Condition MeSH

11110-0.100.10.20.30.40.50.60.70.80.911.1Breast NeoplasmsAtrophic VaginitisAntisocial Personality DisorderAnxiety Disorders[disabled in preview]
Condition MeSH for TESTOSTERONE PROPIONATE
Intervention Trials
Breast Neoplasms 1
Atrophic Vaginitis 1
Antisocial Personality Disorder 1
Anxiety Disorders 1
[disabled in preview] 0
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Clinical Trial Locations for TESTOSTERONE PROPIONATE

Trials by Country

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Trials by Country for TESTOSTERONE PROPIONATE
Location Trials
United States 4
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Trials by US State

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Trials by US State for TESTOSTERONE PROPIONATE
Location Trials
Texas 2
Vermont 1
Rhode Island 1
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Clinical Trial Progress for TESTOSTERONE PROPIONATE

Clinical Trial Phase

33.3%33.3%33.3%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 4Phase 1/Phase 2N/A[disabled in preview]
Clinical Trial Phase for TESTOSTERONE PROPIONATE
Clinical Trial Phase Trials
Phase 4 1
Phase 1/Phase 2 1
N/A 1
[disabled in preview] 0
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Clinical Trial Status

66.7%33.3%0-0.200.20.40.60.811.21.41.61.822.2CompletedSuspended[disabled in preview]
Clinical Trial Status for TESTOSTERONE PROPIONATE
Clinical Trial Phase Trials
Completed 2
Suspended 1
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Clinical Trial Sponsors for TESTOSTERONE PROPIONATE

Sponsor Name

trials000111112222University of Texas at AustinUniversity of Vermont[disabled in preview]
Sponsor Name for TESTOSTERONE PROPIONATE
Sponsor Trials
University of Texas at Austin 2
University of Vermont 1
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Sponsor Type

100.0%000.511.522.53Other[disabled in preview]
Sponsor Type for TESTOSTERONE PROPIONATE
Sponsor Trials
Other 3
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Testosterone Propionate: Clinical Trials, Market Analysis, and Projections

Introduction to Testosterone Propionate

Testosterone propionate is a form of testosterone replacement therapy (TRT) commonly used to treat conditions associated with low testosterone levels, such as hypogonadism. It is available in various formulations, including injectables, which are a significant segment of the TRT market.

Clinical Trials and Safety Efficacy

Recent Clinical Trials on Testosterone Replacement Therapy

While specific clinical trials on testosterone propionate itself may be less frequent, broader studies on testosterone replacement therapy provide valuable insights. For instance, the TRAVERSE trial, led by the Cleveland Clinic, investigated the cardiovascular safety of testosterone replacement therapy. This randomized, double-blind, placebo-controlled trial involved 5,246 men aged 45 to 80 with preexisting or high risk of cardiovascular disease and symptoms of hypogonadism. The trial found that testosterone replacement therapy did not increase the incidence of major adverse cardiac events, addressing long-standing concerns about cardiovascular safety[4].

Efficacy of Oral Testosterone Replacement

A recent clinical trial by Marius Pharmaceuticals on KYZATREX (testosterone undecanoate), another form of oral testosterone replacement therapy, showed promising results. The six-month trial involving 139 men with low testosterone levels demonstrated that KYZATREX was up to 96% effective in restoring normal testosterone levels by Day 90. This study highlights the efficacy of oral testosterone replacement therapies, which could influence the broader market including testosterone propionate[1].

Market Analysis

Global Market Size and Growth

The global testosterone replacement therapy market, which includes testosterone propionate, is experiencing significant growth. In 2022, the market size was valued at USD 1,893.13 million and is projected to reach USD 2,790.23 million by 2030, growing at a CAGR of 4.60%[3].

Segment Analysis

  • Product Type: The market is segmented into injectables, topical formulations, and others. Injectables, which include testosterone propionate, are a major segment due to their efficacy and convenience.
  • Active Ingredients: Testosterone propionate, testosterone cypionate, testosterone enanthate, and others are key active ingredients. Testosterone propionate is particularly popular due to its shorter half-life, which allows for more frequent dosing and better control over testosterone levels[5].
  • End Users: Hospitals, specialty clinics, and homecare are the primary end users. The increasing preference for homecare and self-administration of injectables is driving growth in this segment.
  • Distribution Channels: Hospital pharmacies, online pharmacies, and retail pharmacies are the main distribution channels. Online pharmacies are gaining traction due to convenience and accessibility[3].

Regional Analysis

  • North America: This region is expected to dominate the market due to high expenditure on research and development, advanced healthcare infrastructure, and government initiatives.
  • Asia-Pacific: This region is projected to exhibit the highest growth rate during the forecast period. Factors such as rapidly developing medical infrastructure, rising medical tourism, and increasing awareness about age-related testosterone deficiency are driving this growth[3][5].

Market Drivers

Aging Population and Hormone Imbalance

The global aging population is a significant driver of the testosterone replacement therapy market. As people age, their natural testosterone levels decrease, leading to symptoms like fatigue, reduced muscle mass, and sexual dysfunction. The demand for TRT to address these issues is increasing, fueling market growth[3].

Increasing Awareness and Education

Growing awareness and education about testosterone deficiency and the benefits of TRT are driving market growth. Personalized medicine, which involves tailoring hormone replacement regimens to individual needs, is also a growing trend, enhancing treatment outcomes and reducing side effects[3].

Technological Advancements

Advancements in genetic testing and diagnostics enable better understanding of patients' hormonal profiles, leading to more precise and effective treatment plans. Telemedicine and remote monitoring are also becoming more prevalent, making TRT more accessible and convenient[3].

Market Restraints

High Regulatory Scrutiny and Safety Concerns

High regulatory scrutiny and ongoing safety concerns, particularly regarding cardiovascular risks, can restrain market growth. Although recent trials like the TRAVERSE trial have alleviated some concerns, regulatory bodies continue to monitor the safety of TRT products closely[4].

High Risk of Side Effects

Testosterone replacement therapy, including testosterone propionate, can have side effects such as acne, sleep apnea, and prostate issues. These risks need to be carefully managed, and patients must be closely monitored, which can be a restraint for some potential users[3].

Projections and Future Outlook

The testosterone replacement therapy market, including the segment for testosterone propionate, is poised for significant growth. Here are some key projections:

  • Market Size: The market is expected to grow from USD 1.63 billion in 2024 to USD 3.16 billion by 2032, at a CAGR of 8.9%[5].
  • Regional Growth: Asia-Pacific is expected to witness the fastest growth due to developing medical infrastructure and increasing awareness about men's health[5].
  • Product Innovations: There will be a continued focus on developing more convenient and effective formulations, such as oral and topical products, to complement injectables like testosterone propionate[1].

Key Takeaways

  • The testosterone replacement therapy market, including testosterone propionate, is driven by the aging population and increasing awareness about hormone imbalances.
  • Recent clinical trials have alleviated concerns about cardiovascular safety, supporting the growth of the market.
  • The Asia-Pacific region is expected to exhibit the highest growth rate due to developing healthcare infrastructure and rising awareness.
  • High regulatory scrutiny and potential side effects remain key restraints that need to be managed.

FAQs

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

The current market size of the testosterone replacement therapy market was valued at USD 1,893.13 million in 2022 and is projected to grow significantly over the next decade[3].

Which region is expected to dominate the testosterone replacement therapy market?

North America is expected to dominate the market due to high expenditure on research and development and advanced healthcare infrastructure[3].

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

The primary drivers include the aging population, increasing awareness and education about hormone imbalances, and technological advancements in diagnostics and treatment[3].

Are there any significant safety concerns associated with testosterone replacement therapy?

Yes, there have been concerns about cardiovascular safety, but recent trials like the TRAVERSE trial have shown that testosterone replacement therapy does not increase the incidence of major adverse cardiac events[4].

What is the projected CAGR for the testosterone replacement therapy market from 2025 to 2032?

The market is projected to grow at a CAGR of 8.9% from 2025 to 2032[5].

Sources

  1. Marius Pharmaceuticals Announces Final Published Phase 3 Data ... - Marius Pharmaceuticals, PRNewswire, April 11, 2024.
  2. Testosterone Propionate Market Report 2024 (Global Edition) - Cognitivemarketresearch.com.
  3. Testosterone Replacement Therapy Market Size & Growth Drivers ... - Databridgemarketresearch.com.
  4. Cleveland Clinic-Led Trial Finds Testosterone-Replacement ... - Cleveland Clinic Newsroom, June 16, 2023.
  5. Testosterone Replacement Therapy Market Size(2025-2032) - Skyquestt.com.

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