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.

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.

Clinical Trial Conditions for Medroxyprogesterone Acetate

Condition Name

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

Condition MeSH

Condition MeSH for Medroxyprogesterone Acetate
Intervention	Trials
Endometrial Neoplasms	11
Infertility	10
HIV Infections	9

Clinical Trial Locations for Medroxyprogesterone Acetate

Trials by Country

Trials by Country for Medroxyprogesterone Acetate
Location	Trials
United States	297
Canada	18
Brazil	6
Thailand	6
France	5

Trials by US State

Trials by US State for Medroxyprogesterone Acetate
Location	Trials
California	17
Pennsylvania	14
Virginia	12
North Carolina	12
Texas	12

Clinical Trial Progress for Medroxyprogesterone Acetate

Clinical Trial Phase

Clinical Trial Phase for Medroxyprogesterone Acetate
Clinical Trial Phase	Trials
Phase 4	26
Phase 3	21
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for Medroxyprogesterone Acetate
Clinical Trial Phase	Trials
Completed	78
Recruiting	16
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	162
Industry	36
NIH	31

Medroxyprogesterone Acetate: Clinical Trials, Market Analysis, and Projections

What is Medroxyprogesterone Acetate?

Medroxyprogesterone acetate (MPA) is a synthetic progestogen, a type of hormone drug that mimics the natural hormone progesterone. It is widely used in various medical applications, including cancer treatment, contraception, and hormone replacement therapy[1][4].

Clinical Uses of Medroxyprogesterone Acetate

Cancer Treatment

MPA is used to treat cancers that are hormone-sensitive, such as womb (endometrial), kidney (renal), and breast cancer in postmenopausal women. It works by interfering with the hormone balance in the body, reducing the growth of cancer cells that depend on hormones[1].

Contraception

One of the most well-known forms of MPA is the depot medroxyprogesterone acetate (DMPA), marketed as Depo-Provera. This is an injectable contraceptive that provides long-term birth control with a failure rate of 0.2% with perfect use and 6% with typical use[4].

Hormone Replacement Therapy

MPA is also used in hormone replacement therapy (HRT) regimens, often combined with estrogens. It helps manage symptoms of menopause and can prevent osteoporosis, but it also comes with potential side effects such as breast tenderness, mastalgia, and changes in libido[3].

Other Uses

Additionally, MPA can be used to treat conditions like endometriosis and to manage poor appetite in certain cases. It is also used to alleviate hot flushes in men undergoing hormone therapy for prostate cancer[1].

How Does Medroxyprogesterone Acetate Work?

MPA belongs to the class of progestogens, which act like the natural hormone progesterone. It influences the growth and activity of cells and organs by altering the hormone balance in the body. This mechanism is crucial in treating hormone-sensitive cancers and in providing contraceptive effects[1].

Administration of Medroxyprogesterone Acetate

MPA can be administered in various forms:

• Oral Tablets: Used for cancer treatment and other indications, these tablets are taken daily with a drink of water[1].
• Injectable Forms: DMPA is administered via intramuscular or subcutaneous injection, providing contraception for up to 12 weeks[4].

Clinical Trials and Research

Ongoing and Recent Trials

While specific recent clinical trials on MPA are not detailed in the sources, ongoing research often focuses on optimizing dosages, exploring new applications, and assessing long-term safety and efficacy. For example, studies have been conducted on the use of MPA for acute uterine bleeding and its effects in combination with other hormones[3].

Safety and Efficacy

Clinical trials have established the safety and efficacy of MPA in its various applications. However, like all medications, it comes with potential side effects, such as changes in menstrual bleeding, breast tenderness, and impacts on libido and mood[1][3].

Market Analysis of Medroxyprogesterone Acetate

Global Market Size and Growth

The global medroxyprogesterone acetate market is expected to grow at a compound annual growth rate (CAGR) of 3 to 5% from 2024 to 2031. The market size is estimated to increase significantly, driven by its diverse applications in contraception, cancer treatment, and hormone replacement therapy[2][5].

Market Segmentation

The market is segmented based on type (oral, parenteral), application (contraceptive, hormone replacement therapy, treatment of endometriosis, other), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[5].

Regional Analysis

The market analysis reveals that different regions have varying demands and growth rates. For instance, the Asia-Pacific region is expected to show significant growth due to increasing healthcare needs and access to contraceptive services[2].

Competitive Landscape

The market is competitive, with several key players involved in the production and distribution of MPA. The competitive analysis includes factors such as market share, product offerings, and strategic initiatives of these players[2].

Market Projections

Forecast Period

The forecast period from 2024 to 2031 indicates a positive growth trajectory for the medroxyprogesterone acetate market. This growth is driven by increasing demand for contraceptive services, the expanding use in cancer treatment, and the need for hormone replacement therapy[2][5].

Key Drivers and Restraints

Key drivers include the rising awareness of contraceptive options, advancements in healthcare infrastructure, and the increasing incidence of hormone-sensitive cancers. Restraints may include side effects associated with MPA, regulatory challenges, and competition from other hormonal therapies[2].

Geographical Trends

Geographical trends suggest that emerging markets in Asia-Pacific and Latin America will contribute significantly to the growth of the MPA market. These regions are experiencing rapid urbanization and improvements in healthcare access, leading to higher demand for MPA products[2].

Key Takeaways

• Diverse Applications: Medroxyprogesterone acetate is used in cancer treatment, contraception, and hormone replacement therapy.
• Mechanism of Action: It works by altering the hormone balance in the body, affecting hormone-sensitive cells and organs.
• Administration Forms: Available as oral tablets and injectable forms.
• Market Growth: The global market is expected to grow at a CAGR of 3 to 5% from 2024 to 2031.
• Regional Growth: Asia-Pacific and Latin America are expected to be key growth regions.

FAQs

What is medroxyprogesterone acetate used for?

Medroxyprogesterone acetate is used for treating hormone-sensitive cancers, as a contraceptive, in hormone replacement therapy, and for managing conditions like endometriosis and poor appetite.

How does medroxyprogesterone acetate work?

It works by interfering with the hormone balance in the body, affecting the growth and activity of hormone-sensitive cells and organs.

What are the common side effects of medroxyprogesterone acetate?

Common side effects include changes in menstrual bleeding, breast tenderness, mastalgia, and impacts on libido and mood.

What are the different forms of medroxyprogesterone acetate?

It is available as oral tablets and injectable forms, including depot medroxyprogesterone acetate (DMPA).

What is the market outlook for medroxyprogesterone acetate?

The global market is expected to grow at a CAGR of 3 to 5% from 2024 to 2031, driven by increasing demand in various medical applications.

Sources

1. Cancer Research UK: Medroxyprogesterone acetate (Provera) - Cancer Research UK.
2. Cognitive Market Research: Medroxyprogesterone Acetate Market Report 2024 (Global Edition).
3. Elsevier Healthcare Hub: Medroxyprogesterone - Elsevier healthcare hub.
4. Wikipedia: Medroxyprogesterone acetate - Wikipedia.
5. Market Research Intellect: Medroxyprogesterone Acetate Market Size And Forecast.

Last updated: 2025-01-01