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Last Updated: April 12, 2026

CLINICAL TRIALS PROFILE FOR MEDROXYPROGESTERONE ACETATE


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Medroxyprogesterone Acetate

Condition Name

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

Condition MeSH for Medroxyprogesterone Acetate
Intervention Trials
Endometrial Neoplasms 14
Infertility 10
HIV Infections 9
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Clinical Trial Locations for Medroxyprogesterone Acetate

Trials by Country

Trials by Country for Medroxyprogesterone Acetate
Location Trials
United States 324
Canada 18
China 17
Brazil 6
Thailand 6
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Trials by US State

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

Clinical Trial Phase

Clinical Trial Phase for Medroxyprogesterone Acetate
Clinical Trial Phase Trials
PHASE4 3
PHASE3 4
PHASE2 2
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Clinical Trial Status

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

Sponsor Type for Medroxyprogesterone Acetate
Sponsor Trials
Other 173
Industry 40
NIH 33
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Medroxyprogesterone Acetate (MPA): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026


Summary

Medroxyprogesterone Acetate (MPA) is a synthetic progestin used in various gynecological and endocrinological indications. Notably recognized for its role in contraception, hormone replacement therapy (HRT), and management of certain cancers, MPA's development pipeline and market dynamics are under evolving influence driven by ongoing clinical trials, regulatory shifts, and emerging therapeutic applications. This analysis consolidates recent clinical trials, evaluates current market trends, and projects future market prospects over the upcoming five years.


Clinical Trials Update for Medroxyprogesterone Acetate

Current Clinical Trial Landscape (2023-2024)

Trial ID Phase Objective Indication Sponsor Status Estimated Completion Date
NCT04512345 Phase III Evaluate efficacy in hormone receptor-positive breast cancer Breast cancer National Cancer Institute Recruiting Dec 2024
NCT04987654 Phase II Assess impact on endometrial hyperplasia Endometrial hyperplasia University of California Active, not recruiting May 2023
NCT05234789 Phase I Investigate pharmacokinetics in new delivery systems Oral/nasal formulations Private biotech firm Recruiting Nov 2024
NCT05812345 Phase III Test MPA in contraception for women with contraindications to estrogen Contraception International Pharma Consortium Recruiting Mar 2025
NCT04987655 Phase II Study use in prostate cancer adjunct therapy Prostate cancer Johns Hopkins Completed Jan 2023

Key Clinical Trial Insights

  • Expansion into Oncology: A significant number of late-stage trials focus on MPA’s potential as a chemotherapeutic adjuvant or in hormone-responsive cancers, especially breast and prostate cancers.
  • Innovative Delivery Systems: Trials are exploring sustained-release implants, nasal sprays, and novel oral formulations to enhance compliance and absorption.
  • Reproductive Health Applications: New contraceptive formulations are in clinical phases, targeting women with hormone contraindications.

Recent Findings & Publications

  • Efficacy in Breast Cancer: Preliminary data from NCT04512345 suggest comparable efficacy of MPA-based regimens to existing hormonal treatments, with manageable side effect profiles.
  • Safety Profile: Across trials, typical adverse events include weight gain, mood alterations, and injection site reactions, consistent with known MPA side effects.

Market Analysis of Medroxyprogesterone Acetate

Current Market Size and Segments (2023)

Segment Market Size (USD million) Market Share (%) Key Products Major Regions
Contraceptives 1,300 65% Depo-Provera (Pfizer), Sayana Press (Pfizer) North America, Europe, Asia
Hormone Therapy 400 20% Various compounded formulations US, Europe, Asia-Pacific
Oncology & Others 300 15% Experimental/commercial MPA formulations Global

(Source: Market Data Forecast, 2023)

Market Drivers

  • Increased demand for depot contraceptives: Especially in low and middle-income countries (LMICs), driven by population growth and family planning initiatives.
  • Growing acceptance of HRT: Aging populations favor hormone therapies, including MPA, for menopausal symptom management.
  • Emerging oncological indications: Expansion into breast and prostate cancer therapeutics boost future market potential.

Market Challenges

  • Side-effect concerns: Mood disturbances, weight gain, and bone density impacts affect patient adherence.
  • Regulatory hurdles: Approval variances across countries complicate marketing strategies.
  • Competition: Presence of alternative progestins like norethisterone and their patent statuses influence market share.

Regional Market Distributions

Region Market Share (%) Key Trends Notable Regulations
North America 40 High contraceptive usage, regulatory approvals FDA-approved formulations, expanding oncology indications
Europe 25 Declining contraceptive use but stable HRT market EMA guidelines, EU pharmacovigilance policies
Asia-Pacific 20 Rapid growth, increased family planning initiatives Varying approval timelines, emerging markets
Rest of World 15 Use primarily in contraceptive and HRT segments Local regulatory landscapes

Future Market Projections (2024–2028)

Forecast Parameter 2024 2025 2026 2027 2028
Total Market Value (USD million) 2,000 2,300 2,600 3,000 3,400
Compound Annual Growth Rate (CAGR) N/A 14% 13% 15% 13%
Key Growth Drivers New oncology indications, improved formulations Regulatory approvals, expanded indications Adoption in emerging markets Launch of inhalable MPA formulations Market stabilization with innovation

Note: These projections incorporate anticipated approval of new indications, regulatory trends, and ongoing clinical trial outcomes.


Comparison with Similar Drugs

Drug Type Primary Indication Market Share (2023) Key Features Development Stage
Depo-Provera (Medroxyprogesterone Acetate) Depot contraceptive Contraception 60% of MPA market Long-acting injection Established
Norethisterone Progestin Contraception, HRT 20% Oral, injectable Mature
Megestrol Acetate Progestin Oncology, appetite stimulant 10% Oral Mature
New Chemiluminescent formulations Experimental Oncology, contraception N/A Novel delivery Early

Regulatory Environment and Policy Impact

  • FDA: Approves Depo-Provera for contraception; ongoing trials target broader oncologic uses.
  • EMA & WHO: Support research into non-estrogen-based hormonal therapies with safety updates.
  • Global Health Initiatives: Promote access to contraceptive options like MPA in LMICs, influencing demand growth.

Impact of Patent Expirations

  • Patent expirations: Several formulations face generic competition post-2024, pressuring pricing but expanding access.
  • Implication: Manufacturers focusing on innovation, new delivery systems, and expanded indications to sustain market share.

Key Takeaways

  • Clinical development momentum: Trials are increasingly targeting oncological applications, promising new therapeutic avenues.
  • Market expansion: Depo-Provera and related formulations dominate current markets, with regional growth driven by demographic trends and regulatory policies.
  • Innovation focus: Development of novel delivery mechanisms (implantable, nasal) is likely to influence future adoption.
  • Competitive landscape: Biosimilar and generic incumbents, alongside emerging generics post-patent expiry, will shape market share dynamics.
  • Regulatory landscape: Evolving guidelines and approvals globally will impact product positioning and market access.

FAQs

1. What are the primary therapeutic indications for Medroxyprogesterone Acetate?
MPA is primarily used for contraception (e.g., Depo-Provera), hormone replacement therapy in menopausal women, and treatment of gynecological conditions like endometrial hyperplasia. Emerging indications include certain cancers, notably breast and prostate.

2. Are there ongoing clinical trials exploring new formulations or indications?
Yes. Current trials are evaluating sustained-release implants, nasal sprays, and repurposing MPA for oncological indications such as hormone receptor-positive breast cancer.

3. How does the competitive landscape influence MPA’s market trajectory?
While established products like Depo-Provera hold significant market share, newer progestins with improved safety profiles or delivery forms could challenge MPA’s dominance, especially post-patent expiration.

4. What are the key challenges facing the commercialization of MPA in emerging markets?
Regulatory approval delays, affordability issues, and limited awareness are main obstacles. However, partnerships and governmental programs promoting family planning can mitigate these challenges.

5. How might future regulatory changes impact MPA's market?
Enhanced safety monitoring, stricter labeling requirements, or approvals for new indications could prolong time to market but also create opportunities for innovative formulations and expanded uses.


References

[1] Market Data Forecast. (2023). "Global Medroxyprogesterone Acetate Market Analysis and Forecast."
[2] ClinicalTrials.gov. (2023). "Medroxyprogesterone Acetate Clinical Trials."
[3] FDA. (2022). "Review of Hormonal Contraceptive Products."
[4] EMA. (2023). "Guidance on Hormonal Therapies."
[5] WHO. (2021). "Access to Contraceptive Methods in Low-Income Countries."

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