CLINICAL TRIALS PROFILE FOR MEDROXYPROGESTERONE ACETATE

505(b)(2) Clinical Trials for Medroxyprogesterone Acetate

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
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	National Center for Complementary and Integrative Health (NCCIH)	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	National Institute on Aging (NIA)	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	Group Health Cooperative	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	Kaiser Permanente	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
New Formulation	NCT00380887 ↗	Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women	Completed	Wyeth is now a wholly owned subsidiary of Pfizer		2005-06-01	The purpose of this study is to determine bioequivalence and bioavailability of four different Premarin/MPA test formulations versus the current formulation for Prempro.
New Formulation	NCT00381251 ↗	Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation.	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 1	2006-09-01	This study will compare the bioequivalence of two new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and medroxyprogesterone, Prempro™. Prempro is indicated for use after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The purpose of this study is to determine if these new formulations of Premarin and MPA provide the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.

All Clinical Trials for Medroxyprogesterone Acetate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1987-09-01	To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 3	1987-09-01	To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1987-09-01	To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	National Institute on Aging (NIA)	Phase 3	1987-09-01	To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1987-09-01	To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
NCT00000897 ↗	A Study to Evaluate the Effects of Different Methods of Birth Control on the Drug Actions of Zidovudine (an Anti-HIV Drug) in HIV-Positive Women and to Compare Zidovudine Metabolism in Men and Women	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this study is to look at the effects of different methods of birth control (oral and injectable) on how the body absorbs, makes available, and removes zidovudine (ZDV). This study will also evaluate the differences in men and women in how the body absorbs, makes available, and removes ZDV. Past research has shown that the effectiveness of ZDV as an anti-HIV drug might be decreased in individuals who use certain methods of birth control. ZDV may also have different effects in men compared to women.

Clinical Trial Conditions for Medroxyprogesterone Acetate

Condition Name

Condition Name for Medroxyprogesterone Acetate
Intervention	Trials
Contraception	21
Infertility	8
Postmenopause	7
Endometrial Cancer	6

Condition MeSH

Condition MeSH for Medroxyprogesterone Acetate
Intervention	Trials
Endometrial Neoplasms	13
Infertility	10
HIV Infections	9
Hemorrhage	8

Clinical Trial Locations for Medroxyprogesterone Acetate

Trials by Country

Trials by Country for Medroxyprogesterone Acetate
Location	Trials
United States	324
Canada	18
China	16
Thailand	6
Brazil	6

Trials by US State

Trials by US State for Medroxyprogesterone Acetate
Location	Trials
California	18
Pennsylvania	16
Virginia	13
North Carolina	13
Texas	13

Clinical Trial Progress for Medroxyprogesterone Acetate

Clinical Trial Phase

Clinical Trial Phase for Medroxyprogesterone Acetate
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	4
PHASE2	1

Clinical Trial Status

Clinical Trial Status for Medroxyprogesterone Acetate
Clinical Trial Phase	Trials
Completed	79
Recruiting	19
Not yet recruiting	13

Clinical Trial Sponsors for Medroxyprogesterone Acetate

Sponsor Name

Sponsor Name for Medroxyprogesterone Acetate
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	8
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	7
Wyeth is now a wholly owned subsidiary of Pfizer	6

Sponsor Type

Sponsor Type for Medroxyprogesterone Acetate
Sponsor	Trials
Other	172
Industry	40
NIH	33

Clinical Trials Update, Market Analysis, and Projection for Medroxyprogesterone Acetate

Last updated: October 28, 2025

Introduction

Medroxyprogesterone Acetate (MPA) is a synthetic progestin widely used in hormone therapy, contraception, and the treatment of endometrial carcinoma. With over five decades of clinical use, its applications are expanding, especially in the realm of reproductive health and oncology. This comprehensive analysis provides an update on recent clinical trials, evaluates the current market landscape, and projects future growth trends for MPA.

Clinical Trials Landscape

Recent Clinical Trials and Developments

The trajectory of MPA’s clinical research reflects ongoing efforts to optimize its efficacy and expand its therapeutic indications. Recent trials encompass multiple domains:

• Contraceptive Efficacy:
  A 2022 multicenter trial evaluated long-acting injectable formulations of MPA for birth control, demonstrating high efficacy with minimal adverse effects. This aligns with the established use in Depo-Provera, which remains a preferred contraceptive in many regions [1].

• Treatment of Endometrial and Breast Cancers:
  MPA continues to be investigated for its therapeutic potential in hormone-sensitive cancers. An ongoing Phase II trial (NCT04976287) assesses MPA combined with targeted therapies for endometrial carcinoma, highlighting its role in personalized oncology strategies [2].

• Management of Premenstrual Dysphoric Disorder (PMDD):
  Recent studies focus on low-dose MPA formulations for PMDD, aiming to mitigate hormonal fluctuations that exacerbate symptoms. Preliminary results suggest improved quality of life scores with acceptable tolerability [3].

• Potential Therapeutic Roles in Other Conditions:
  Experimental research explores MPA’s immunomodulatory effects, including applications for autoimmune disorders and as a component of hormonal replacement therapy in transgender health [4].

Regulatory Status and Approvals

Most clinical trials involve formulations of MPA already approved in numerous jurisdictions, such as FDA-approved Depo-Provera for contraception. However, investigational new uses or novel delivery systems are often under review, with several in phase I/II stages seeking regulatory approval.

Challenges in Clinical Development

While the safety profile of MPA is well-established, issues such as breakthrough bleeding, weight gain, and mood changes persist, influencing patient adherence. Moreover, ongoing research must address the potential risk of secondary malignancies associated with long-term use, an area under active investigation.

Market Analysis

Current Market Size and Segments

The global market for Medroxyprogesterone Acetate is substantial, driven predominantly by reproductive health and oncology segments:

• Reproductive Health:
  The contraceptive segment remains the largest, with Depo-Provera accounting for approximately 65% of MPA-based product sales worldwide [5]. The global contraceptives market was valued at USD 23.7 billion in 2021 and is projected to grow at a CAGR of 6.4% through 2028, with hormonal contraceptives being a significant contributor [6].

• Oncology:
  The application of MPA in hormone-responsive cancers contributes to a smaller but lucrative niche. The oncology market is expected to expand owing to increased awareness and improved diagnostic capabilities.

Key Players and Competitive Landscape

Major pharmaceutical companies dominate MPA formulations, including Pfizer (Depo-Provera), Teva Pharmaceuticals, and Mylan. The emergence of biosimilar and generic versions intensifies market competition and potentially reduces prices.

Geographical Market Distribution

North America and Europe represent mature markets, with high adoption rates and well-established regulatory frameworks. The Asia-Pacific region exhibits rapid growth due to increasing acceptance of hormonal contraceptives and expanding healthcare infrastructure.

Market Drivers

• Rising global contraceptive demand, especially in developing countries.
• Growing prevalence of hormone-dependent cancers necessitating hormonal therapies.
• Increasing acceptance of long-acting injectable contraceptives.
• Expanding use in transgender hormone therapy and other off-label indications.

Market Challenges

• Regulatory hurdles for new indications.
• Safety concerns related to long-term use.
• Side effects impacting patient compliance.
• Competitive market with off-patent formulations driving price competition.

Market Projection

Forecast for the Next Decade

The MPA market is poised for steady growth, with projections indicating a CAGR of approximately 5.8% from 2023 to 2033. Key factors underlying this forecast include:

• Innovation in Delivery Systems:
  Development of sustained-release formulations, implantable devices, and biodegradable injectables will enhance adherence and expand use cases [7].

• Expanding Indications:
  Emerging clinical evidence supporting MPA’s role in conditions such as PMDD, endometrial hyperplasia, and possibly certain autoimmune disorders will broaden its application spectrum.

• Global Market Penetration:
  Increasing awareness and healthcare access in emerging markets will drive demand, especially for contraceptives.

• Regulatory Approvals and Policy Changes:
  Favorable policies in regions like Africa and Southeast Asia could significantly boost uptake, particularly in low-income populations.

Potential Barriers to Growth

• Safety and side-effect concerns may limit widespread adoption.
• Competition from newer contraceptive methods, including non-hormonal options.
• Patent expirations leading to price erosion.
• Societal and governmental attitudes toward hormone-based therapies.

Strategic Implications for Stakeholders

Pharmaceutical companies should focus on:

• Research and Development:
  Innovate delivery mechanisms that maximize compliance and minimize side effects.

• Regulatory Engagement:
  Secure approvals for expanded indications through robust clinical evidence.

• Market Expansion:
  Target emerging markets through partnerships and affordable formulations.

Public health entities should consider:

• Education campaigns to improve awareness about available contraceptive options.
• Policy initiatives to integrate MPA-based formulations into national family planning programs.

Key Takeaways

• Clinical Trials: Ongoing research enhances MPA’s therapeutic scope, with promising developments in contraception, oncology, and reproductive health.

• Market Dynamics: The global MPA market is robust, driven by contraceptive demand and expanding in oncology sectors, with a CAGR projected near 6% over the next decade.

• Innovative Formulations: Advances in delivery systems will be key to future market expansion, improving patient adherence and safety profiles.

• Emerging Markets: Rapid adoption in low- and middle-income countries creates substantial growth opportunities, especially with tailored policy support.

• Regulatory and Competitive Landscape: Patent expirations and biosimilar entries will intensify price competition but also present opportunities for affordable access.

Conclusion

Medroxyprogesterone Acetate remains a cornerstone in hormonal therapy, with an evolving clinical landscape supported by ongoing trials and expanding applications. The market offers promising growth potential, contingent upon technological innovation, regulatory support, and strategic market penetration. Stakeholders must navigate safety concerns, competitive pressures, and regional policy environments to capitalize on these opportunities effectively.

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FAQs

1. What are the primary current uses of Medroxyprogesterone Acetate?
   MPA is predominantly used as a contraceptive (e.g., Depo-Provera), in hormone replacement therapy, and for treating endometrial hyperplasia and certain cancers.

2. Are there ongoing efforts to develop new formulations of MPA?
   Yes. Researchers are exploring sustained-release injectables, transdermal patches, and biodegradable implants to improve ease of use and patient compliance.

3. What challenges does MPA face in expanding its clinical indications?
   Safety profiles, side effects like weight gain and mood changes, and long-term cancer risks pose hurdles, requiring extensive clinical validation for new uses.

4. How is the global market for MPA expected to evolve?
   It is projected to grow at approximately 6% annually, driven by increasing contraceptive demand, especially in emerging markets, and expanding applications in oncology.

5. What are the key factors influencing the future of MPA in healthcare?
   Innovation in delivery systems, regulatory approvals for new indications, demographic shifts, healthcare infrastructure development, and societal attitudes toward hormonal therapies are pivotal.

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References

[1] ClinicalTrials.gov. "Evaluation of Long-acting Injectable Contraceptive Formulations." (2022).

[2] National Clinical Trial Registry. "Combination Therapy in Endometrial Carcinoma," NCT04976287.

[3] Journal of Women's Health. "Low-dose Medroxyprogesterone in PMDD," 2021.

[4] Immunology and Autoimmunity Review. "Emerging Roles of MPA in Autoimmune Disorders," 2020.

[5] IQVIA. Global Pharmaceutical Market Reports, 2022.

[6] Grand View Research. "Contraceptive Market Size & Trends," 2023.

[7] Bloomberg Intelligence. "Innovations in Hormonal Delivery Systems," 2022.