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	14
Infertility	10
HIV Infections	9

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
Wyeth is now a wholly owned subsidiary of Pfizer	6

Sponsor Type

Sponsor Type for MEDROXYPROGESTERONE ACETATE
Sponsor	Trials
Other	173
Industry	40
NIH	33

Last updated: July 28, 2026

Medroxyprogesterone Acetate Clinical Trials Update, Market Analysis, and Forecast by Formulation

Medroxyprogesterone acetate (MPA) remains a long-established progestin with mature clinical evidence and multiple approved product lines (oral tablets, injectable suspensions, and contraceptive-related uses). Recent “clinical trials updates” in the public domain are limited because the compound is off-patent in many markets and most current activity centers on label extensions, device/drug combinations, formulation/process improvements, and safety follow-on studies rather than novel mechanism breakthroughs.

This report compiles (1) where public registries show ongoing or recently completed interventional studies for MPA, (2) the market structure by major therapeutic use and delivery form, and (3) a time-phased revenue and volume forecast framework aligned to typical progestin demand drivers. It also maps the main regulatory and IP barriers that influence generic and biosafety-like substitution risk (though MPA is a small molecule, not a biologic).

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What clinical trials are ongoing for medroxyprogesterone acetate in 2024 to 2026?

Which study types dominate recent MPA activity

Across public trial registries, MPA studies skew toward:

• Contraception-related evaluations of progestin-only use schedules (often in combination product contexts).
• Abnormal uterine bleeding (AUB) and endometrial disorders, usually as efficacy/safety follow-ups tied to established clinical pathways.
• Menopausal hormone therapy regimens where progestins are used to protect the endometrium in combination with estrogen.
• Formulation or bioequivalence studies (typical for older generics and route optimization).
• Pharmacokinetic (PK) and tolerability work for long-acting injectable preparations.

Where to expect the newest trial signals

For MPA specifically, “newness” in the pipeline more often comes from:

• New salts, release profiles, or dosing schedules rather than a new target.
• Regional registries where sponsors run comparative safety or patient-reported outcome studies after guideline updates.
• Non-interventional post-marketing surveillance captured in trial systems but not always categorized as clinical trials in commercial databases.

Clinical trial update outcome pattern

Given the compound’s age and broad generic availability, the most commercially relevant trial outcomes tend to be:

• Changes to preferred dosing intervals (especially for depot injections).
• Refinement of indications and patient selection for AUB-related progestin use.
• Evidence supporting switching rules between oral and injectable regimens.

(Note: Public interventional trial listings for MPA vary in completeness by registry. The practical business takeaway is that current trial activity tends to be incremental rather than translational.)

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How does medroxyprogesterone acetate market demand split by therapeutic indication and formulation?

Primary demand buckets

MPA revenue is typically concentrated in:

1. Contraception
   • Depot medroxyprogesterone acetate (DMPA) formulations.
   • Progestin-only contraception where tolerated and guideline-compliant.
2. Gynecology
   • Management of endometriosis-associated pain (where progestins are used).
   • AUB and related conditions, commonly as standard-of-care progestin therapy.
3. Oncology and off-label
   • Uses in advanced endometrial and hormone-responsive settings are less likely to represent the largest volume, but can contribute to institutional utilization.
4. Menopause/HRT endometrial protection
   • MPA as the progestin component with estrogen to reduce endometrial hyperplasia risk.

Formulation-by-formulation commercial dynamics

• Injectable (long-acting): higher switching costs, stronger adherence linkage, and fewer substitution events at the point of care.
• Oral tablets: more exposed to generic price competition with frequent pharmacy-level substitution.
• Specialty combinations (where applicable): can hold value via branding and dosing convenience, but face generic pressure once components are clearly mapped.

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What is the current global competitive landscape for medroxyprogesterone acetate?

Market structure

MPA is a mature, multi-source small molecule. Competitive positioning depends primarily on:

• Manufacturing reliability for depot injections (supply continuity and lot consistency).
• Distribution contracts with wholesalers and tenders (especially for reproductive health programs).
• Tender-based pricing for public health procurement.
• Product perception tied to device convenience, injection interval adherence, and patient counseling.

Key competitor categories

• Brand originator products in select markets (historically important for conversion and clinician preference).
• Multi-generic portfolios for oral and some injectable versions.
• Regional injectable manufacturers that compete on supply, labeling, and tender terms.

Pricing behavior

• Oral MPA: sustained downward pricing pressure.
• Injectables: more stable nominal pricing due to administration logistics, but still face episodic procurement-driven price resets.

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When do medroxyprogesterone acetate products lose exclusivity, and what drives generic entry?

Exclusivity is product-line specific

Because MPA is widely generic, “exclusivity loss” is less about a single future cliff and more about:

• Patent-to-brand expiration timing by jurisdiction.
• Formulation-specific protection (process, polymorph, release profile, sterility assurance).
• Regulatory exclusivities tied to specific application references rather than the base molecule.

Generic entry mechanics that matter commercially

• Oral: entry is primarily an Abbreviated pathway business, with bioequivalence and labeling alignment as gating factors.
• Depot injections: entry can be slower and more institutionally resistant because substitution requires patient counseling continuity and administration protocols.

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Which patents protect medroxyprogesterone acetate products, and how strong is the estate by use case?

Patent estate reality

For MPA as a chemical entity, most “core composition” coverage is historically expired or narrow. Current IP value typically comes from:

• Formulation and manufacturing process patents
• Device or delivery system claims (where integrated with injection systems)
• Method-of-use claims for specific schedules or patient subgroups in certain jurisdictions

High-impact patent claim categories

• Sustained-release injectable manufacturing (sterile suspension preparation, particle size control, and stability).
• Injection interval method-of-use (protocol-level claims).
• Specific regimen claims for AUB and endometriosis subsets.

Litigation posture

IP disputes for mature generics typically center on:

• Paragraph IV-style challenges for referenced applications (in markets where this framework applies).
• Process or formulation infringement for non-identical products.

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What is the Orange Book status of medroxyprogesterone acetate?

Expected listing pattern

MPA products in the US typically appear across:

• Multiple strengths for oral tablets
• Depot and/or suspension products for injectables

Each listing includes:

• Active ingredient
• Dosage form
• Route
• Orange Book exclusivity and listed patents, when any remain associated with the application

Commercial interpretation

• If patents remain listed for a given product, it can delay straightforward approval for direct-to-market generics.
• If no patents remain listed, the competitive path is largely bioequivalence and labeling alignment.

(The practical business approach is to treat the Orange Book status as a per-NDA/per-product variable rather than assuming molecule-level coverage.)

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What formulation patents are important for medroxyprogesterone acetate injectables versus oral tablets?

Depot injectable: what usually protects value

Value retention in depot products typically aligns with:

• Suspension stability and re-suspendability after storage
• Particle size distribution and sedimentation behavior
• Sterility assurance and container-closure system performance

Oral tablets: what usually protects value

Oral MPA value tends to be competed on:

• bioequivalence compliance
• dissolution performance
• stability and manufacturing process consistency

As a result, the injectable segment often sees higher friction for substitution, creating relative pricing resilience.

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How does medroxyprogesterone acetate compare with alternative progestins and contraceptives?

Competitive set

MPA’s principal therapeutic substitutes include:

• Other progestins used in contraception and AUB management (class-level competition)
• Non-hormonal AUB therapies and procedural options in gynecology
• Levonorgestrel-containing options where available and guideline-preferred

Decision factors

• Patient tolerance and side-effect profile
• Adherence and dosing interval
• Bleeding pattern outcomes
• Provider familiarity
• Public program formulary rules

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What generic entry risks exist for medroxyprogesterone acetate products?

Oral products

• High generic substitutability.
• Lower switching costs at pharmacy level.
• Competitor entry is usually rapid once regulatory requirements are met.

Injectable depot products

• Switching friction is higher.
• Institutional procurement and patient onboarding processes slow replacement cycles.
• Supply continuity matters as much as pricing.

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What is the revenue exposure outlook for medroxyprogesterone acetate through 2030?

Projection framework

Because MPA is mature and multi-sourced, the forecast is best modeled by:

• Volume drivers: birth control program trends, fertility planning demographics, contraception persistence/continuation rates.
• Price drivers: tender-based pricing, brand-to-generic share shift, and competitive intensity.
• Mix drivers: injectable vs oral mix and geographic mix.

Base-case directional forecast (market-level)

• Global demand: generally stable to modestly growing in mature markets due to ongoing contraception and gynecology use, offset by competition and guideline shifts.
• Unit economics: gradual compression in oral segments; more stable economics in injectables where substitution barriers persist.
• Net revenue: tends to track volume with downside from pricing, producing a low-to-mid single-digit CAGR in many mature formulations absent major label expansions.

(A numeric forecast requires a specific starting-point dataset by region, brand/generic share, and price. Public sources vary and would risk incorrect quantification.)

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What regulatory milestones affect medroxyprogesterone acetate supply and market access?

US

• Product approvals and label changes flow through standard generic and branded regulatory paths.
• Supply disruptions can occur due to manufacturing line concentration, sterile injectable risks, or quality remediation events, which can temporarily affect procurement availability.

EU and key ex-US markets

• Variations in national formularies drive effective market share more than molecule-level regulation.
• Tender cycles and reimbursement rules determine uptake for AUB and contraception.

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Key Takeaways

• MPA clinical activity in 2024 to 2026 is most often incremental: regimen refinement, safety follow-ups, and formulation/PK work rather than first-in-class mechanism studies.
• Market value concentrates in injectable and institutional procurement channels where substitution is slower than oral pharmacy-level switching.
• IP risk is product-line and jurisdiction specific; most molecule-level exclusivity has already lapsed, leaving formulation and process as the practical protective layer.
• Revenue outlook through 2030 is largely a volume-and-mix story with continued pricing pressure in oral products and relative resilience in depot injectables.

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FAQs

1. Are there new medroxyprogesterone acetate clinical trials showing improved bleeding control or tolerability?
2. Which medroxyprogesterone acetate formulations have the highest generic substitution risk in the US?
3. How do depot medroxyprogesterone acetate continuation rates impact long-term demand forecasting?
4. What manufacturing or quality issues most often disrupt medroxyprogesterone acetate injectable supply?
5. How does medroxyprogesterone acetate compare to levonorgestrel-based options for abnormal uterine bleeding treatment outcomes?

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References

1. ClinicalTrials.gov. “Medroxyprogesterone acetate.” https://clinicaltrials.gov/
2. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. “Medroxyprogesterone acetate.” https://www.accessdata.fda.gov/scripts/cder/ob/