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.

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.

Clinical Trial Conditions for Medroxyprogesterone Acetate

Condition Name

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

Condition MeSH

Condition MeSH for Medroxyprogesterone Acetate
Intervention	Trials
Endometrial Neoplasms	14
Infertility	10
HIV Infections	9
Endometrial Hyperplasia	8

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

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	2

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
FHI 360	6

Sponsor Type

Sponsor Type for Medroxyprogesterone Acetate
Sponsor	Trials
Other	173
Industry	40
NIH	33

Medroxyprogesterone Acetate Market Analysis and Financial Projection

Last updated: April 27, 2026

Medroxyprogesterone Acetate: Clinical Trial Update, Market Analysis, and Projections

What is medroxyprogesterone acetate’s clinical trial status and development direction?

Medroxyprogesterone acetate (MPA) is an established synthetic progestin with long-standing clinical use across multiple indications. Public clinical development today is dominated by (1) label-expansion and life-cycle work (often tied to formulation and regimen optimization), and (2) ongoing studies in gynecologic and hormone-driven disease settings where progestins remain standard-of-care comparators.

Current development characteristics observed in the public clinical-trial record

• Study types: active-comparator trials, cohort studies, and registration-oriented studies tied to reproductive health and hormone-responsive indications.
• Common endpoints: bleeding pattern control, endometrial histology or endometrial thickness, ovulation suppression metrics, treatment-emergence safety, and patient-reported bleeding outcomes.
• Regulatory posture: MPA is not dependent on breakthrough clinical programs to sustain market access. Most active studies are incremental and tied to specific patient subgroups, regimen design, or formulation-specific performance.

Core indications where clinical activity concentrates (typical trial geography and study framing)

• Contraception and reproductive health: trials often target adherence, bleeding control, and acceptable tolerability profiles in depot progestin use.
• Endometriosis-associated bleeding and endometrial-related disorders: trials focus on symptom control and endometrial outcomes using MPA as a systemic progestin comparator or active therapy.
• Hormone-responsive gynecologic indications: trials use progestins for disease control and measure clinical response plus safety.

Clinical-trial transparency note No single unified “single global MPA program” exists because MPA is marketed as multiple products with different dosage forms, and clinical work is split across manufacturers, geographies, and formulations. The practical lens for business planning is indication-level and product-level rather than one monolithic development track.

Primary publicly available clinical-trial source Clinical trial identification and status should be anchored to ClinicalTrials.gov listings, which is the core registry for ongoing and completed interventional work in the US and much of global reporting.
Source: ClinicalTrials.gov (searchable listings for medroxyprogesterone acetate). [1]

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How does the market look today for medroxyprogesterone acetate across major uses?

MPA’s market is shaped by three commercial forces: (1) its role as a progestin backbone in reproductive and hormone therapies, (2) the fact that it is off-patent in many regions, which drives generic competition, and (3) demand stability in contraception and gynecologic indications where depot progestins remain cost-effective options.

Market demand drivers

• Contraception and family planning: depot progestin use supports stable demand in markets that prioritize long-acting, administration-sparing methods.
• Abnormal uterine bleeding and endometrial-related indications: MPA maintains demand through bleeding management pathways, where progestins are standard options.
• Gynecologic hormone-responsive therapies: progestins remain embedded in treatment algorithms, limiting volatility.

Supply and pricing dynamics

• Generic penetration is the dominant factor in mature geographies.
• Product-form differentiation matters: depot injections, oral formulations, and specific dosing regimens can retain local preference even when the active is genericized.
• Tender and procurement channels are important where public health systems select lowest-cost options with established clinical acceptance.

Competitive set

• The competitive landscape is progestin-based and includes other progestins and, depending on indication, alternative hormonal modalities.
• For contraception and bleeding control, the main competitive set includes other long-acting progestins and hormonal regimens that can substitute for MPA depending on patient profile and payer preferences.

Where MPA wins commercially

• Strong position where clinicians and payers prefer established depot progestin algorithms.
• Where cost and formulary inclusion dominate, generic MPA often retains share.

Key market reference sources used for business-level sizing

• WHO and IMS-style market reporting equivalents are commonly used by industry for reproductive health categories, while product-level sales are often captured by paid datasets. Public sources are limited for absolute revenue without paywalled market intelligence.
• Therefore, the most reliable public approach is to model market size from indication prevalence and contraceptive/bleeding therapy uptake, then apply generic market dynamics to project revenue.

Evidence-backed anchors

• Clinical and regulatory descriptions of MPA use and labeling are captured by FDA and global references such as Drugs@FDA and product labels. [2,3]

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What market forecasts are realistic for medroxyprogesterone acetate (base, upside, downside)?

Because MPA is mature and widely genericized, long-term forecasting should be built on volume durability rather than price premium assumptions.

Forecast framework (suitable for investment and R&D planning)

1. Base case: stable or low-growth volume driven by ongoing contraception and gynecologic use, offset by continued generic pricing pressure.
2. Upside case: incremental share gains via improved formulations, better tolerability profiles, or renewed formulary inclusion in major procurement settings.
3. Downside case: substitution away from depot progestins toward alternatives in contraception or bleeding management, or heightened procurement cost pressure.

Revenue math logic

• Mature generic markets usually see price compression over time; revenue growth tends to track units and occasional mix changes (formulation preference, country-level tender shifts).
• For MPA, future growth is more likely to come from unit stability and mix rather than price.

Practical projection ranges (category-level, not product-specific)

• Contraception-driven demand typically grows with population need for contraception but is capped by method mix shifts.
• Bleeding/endometrial indications follow gynecologic incidence patterns and treatment pathway uptake; growth tends to be steady rather than explosive.

Business conclusion Forecasting MPA is a “steady-state” exercise. The market is likely to remain liquid and competitive, with incremental gains tied to formulation-level or distribution-level execution rather than new MoA-driven breakthroughs.

Key inputs to keep forecasts grounded

• Product and dosing form availability by region (injectable vs oral) affects unit conversion.
• Procurement cycles in public tenders determine near-term unit swings.
• Labeling constraints affect which indications each product can be marketed for.

Public reference points for dosing and formulation

• FDA-reviewed labeling content for MPA products and related progestin entries provides dosing and indication boundaries. [2]

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Which clinical trial themes matter most for future product positioning in MPA?

Even in mature actives, the differentiator is not “new science” but execution in endpoints and patient adherence.

Trial themes with commercial relevance

• Bleeding control durability: counts directly in adherence and continuation, especially for progestin-only and depot regimens.
• Tolerability and safety in target subpopulations: discontinuation risk drives real-world persistence.
• Regimen simplification and administration workflow: depot administration schedules can be an advantage in payer and clinic operations.

Trial design expectations

• Most MPA work will remain anchored to established endpoints recognized by regulators and clinicians: bleeding patterns, endometrial response, ovulation suppression (when relevant), and adverse event profiles.

Registry validation Clinical trial status and ongoing interventional records should be verified via ClinicalTrials.gov entries for medroxyprogesterone acetate and indication-specific combinations. [1]

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What are the main IP, regulatory, and lifecycle constraints shaping the outlook?

MPA’s longevity in clinical use generally means it faces the reality of expired or expiring reference product exclusivity in most markets. Commercial strategies typically pivot to:

• Formulation patents (if any) and process improvements
• Method of use for specific dosing regimens or patient populations
• Device-adjacent or delivery improvements for injectables
• Regulatory strategy for line extensions and label maintenance

Regulatory structure anchors

• FDA labeling and approval history define the boundaries for indications and dosing. [2]
• Global usage is reinforced by established medical references and regulatory product dossiers. [3]

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Market and R&D implications for decisions

For business professionals evaluating where to allocate R&D and commercial resources:

• R&D for MPA should target incremental clinical differentiation (bleeding control durability, adherence, tolerability) rather than MoA novelty.
• Commercial strategy should prioritize procurement and payer access because generic competition compresses margins.
• Clinical trial investment should align with endpoints that drive persistence (continuation rates correlate with bleeding tolerability more than small biomarker changes).

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Key Takeaways

• Medroxyprogesterone acetate is a mature, widely used synthetic progestin with clinical development focused on incremental label and regimen refinement rather than foundational MoA innovation. [1]
• The market is structurally shaped by generic competition, so growth is expected to track unit demand and mix shifts more than price.
• Forecasts should be built on stable volume assumptions with low-to-moderate growth scenarios and downside risk from substitution to alternative methods.
• Future differentiation is most likely to come from formulation and regimen execution that improves bleeding control, adherence, and safety outcomes.

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FAQs

1) Is medroxyprogesterone acetate still being studied in clinical trials?

Yes. Public trial listings show ongoing and completed interventional studies that typically focus on reproductive health, gynecologic conditions, and hormone-responsive endpoints. [1]

2) What indications drive the largest practical demand?

Contraception (including depot progestin use) and gynecologic hormone-related indications such as bleeding control and endometrial-related management are the main demand anchors for progestin therapies including MPA. [2,3]

3) How does generic competition affect medroxyprogesterone acetate revenue forecasts?

Generic penetration typically causes sustained price pressure. Revenue growth depends more on unit stability and mix than on premium pricing power.

4) What are the most commercially relevant clinical endpoints for MPA?

Bleeding pattern control, tolerability, safety, and persistence/continuation outcomes are the endpoints that align directly with adherence and real-world treatment continuation. [1]

5) What is the most realistic path to differentiation for new MPA entrants?

Differentiation is usually tied to formulation and regimen improvements, delivery mechanics, and evidence that supports better bleeding control and tolerability in defined patient groups.

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References

[1] ClinicalTrials.gov. (n.d.). Search results for “medroxyprogesterone acetate”. https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. (n.d.). Drugs@FDA: medroxyprogesterone acetate product information and labeling. https://www.accessdata.fda.gov/scripts/cder/daf/
[3] European Medicines Agency. (n.d.). European public assessment reports and product information for medroxyprogesterone acetate-containing medicines. https://www.ema.europa.eu/