CLINICAL TRIALS PROFILE FOR PROVERA

All Clinical Trials for Provera

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00003179 ↗	Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer	Terminated	National Cancer Institute (NCI)	Phase 2	1998-11-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of surgery with or without medroxyprogesterone may be an effective way to prevent the development of endometrial cancer in patients who have endometrial hyperplasia. PURPOSE: Phase II trial to compare the effectiveness of surgery alone with that of medroxyprogesterone followed by surgery in preventing endometrial cancer in patients who have endometrial hyperplasia.
NCT00003179 ↗	Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer	Terminated	Gynecologic Oncology Group	Phase 2	1998-11-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of surgery with or without medroxyprogesterone may be an effective way to prevent the development of endometrial cancer in patients who have endometrial hyperplasia. PURPOSE: Phase II trial to compare the effectiveness of surgery alone with that of medroxyprogesterone followed by surgery in preventing endometrial cancer in patients who have endometrial hyperplasia.
NCT00016601 ↗	Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use With Certain Anti-HIV Drugs in HIV-Infected Women	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	N/A	2001-06-01	The purpose of this study is to look at the level of depo-medroxyprogesterone acetate (DMPA or Depo-Provera) in the blood to see if is affected by certain anti-HIV drugs (nelfinavir [NFV], efavirenz [EFV], indinavir [IDV] in combination with ritonavir [RTV], and nevirapine [NVP]). This study will also look at the levels of these anti-HIV drugs to see if they are affected by DMPA. DMPA is a hormonal birth control method that is given as an injection. It is not known if taking DMPA together with anti-HIV drugs changes the amount of DMPA and/or the amount of anti-HIV drugs in the blood. If higher levels of DMPA occur, side effects may increase. If lower levels of anti-HIV drugs occur, the drugs may become less effective against HIV. This study will look at the levels of anti-HIV drugs and DMPA in the blood when these medications are used together.
NCT00016601 ↗	Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use With Certain Anti-HIV Drugs in HIV-Infected Women	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	2001-06-01	The purpose of this study is to look at the level of depo-medroxyprogesterone acetate (DMPA or Depo-Provera) in the blood to see if is affected by certain anti-HIV drugs (nelfinavir [NFV], efavirenz [EFV], indinavir [IDV] in combination with ritonavir [RTV], and nevirapine [NVP]). This study will also look at the levels of these anti-HIV drugs to see if they are affected by DMPA. DMPA is a hormonal birth control method that is given as an injection. It is not known if taking DMPA together with anti-HIV drugs changes the amount of DMPA and/or the amount of anti-HIV drugs in the blood. If higher levels of DMPA occur, side effects may increase. If lower levels of anti-HIV drugs occur, the drugs may become less effective against HIV. This study will look at the levels of anti-HIV drugs and DMPA in the blood when these medications are used together.

Clinical Trial Conditions for Provera

Condition Name

Condition Name for Provera
Intervention	Trials
Contraception	12
Dysfunctional Uterine Bleeding	3
HIV	3
HIV Infections	3

Condition MeSH

Condition MeSH for Provera
Intervention	Trials
Hemorrhage	5
Metrorrhagia	4
Uterine Hemorrhage	4
Endometrial Hyperplasia	3

Clinical Trial Locations for Provera

Trials by Country

Trials by Country for Provera
Location	Trials
United States	163
Dominican Republic	3
Uganda	2
Canada	2
Puerto Rico	2

Trials by US State

Trials by US State for Provera
Location	Trials
California	13
Pennsylvania	12
Texas	8
North Carolina	7
New York	7

Clinical Trial Progress for Provera

Clinical Trial Phase

Clinical Trial Phase for Provera
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	13
Phase 3	6

Clinical Trial Status

Clinical Trial Status for Provera
Clinical Trial Phase	Trials
Completed	37
Terminated	8
Recruiting	7

Clinical Trial Sponsors for Provera

Sponsor Name

Sponsor Name for Provera
Sponsor	Trials
FHI 360	5
National Institute of Allergy and Infectious Diseases (NIAID)	4
National Cancer Institute (NCI)	4

Sponsor Type

Sponsor Type for Provera
Sponsor	Trials
Other	74
NIH	13
Industry	12

Provera Market Analysis and Financial Projection

Last updated: April 28, 2026

Provera (medroxyprogesterone acetate): clinical trials update and market analysis with projections

What is Provera and who uses it?

Provera is the brand name for medroxyprogesterone acetate (MPA), a synthetic progestin. It is used for multiple indications across women’s health, including:

• Hormone replacement therapy (HRT) regimens for endometrial protection (commonly combined with estrogen)
• Abnormal uterine bleeding due to hormonal imbalance
• Amenorrhea (including secondary amenorrhea)
• Endometriosis and related gynecologic conditions (label-dependent by region)

MPA is a mature, widely available product with limited patent-driven exclusivity in most markets, so the commercial picture is dominated by generic competition, formulation/IP fragments, and regional reimbursement dynamics rather than novel lifecycle programs.

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What do recent clinical-trial signals show for Provera/MPA?

No high-impact, brand-specific late-stage trials that would materially change Provera’s label or competitive positioning were identifiable from high-signal sources in the public domain at the level required for a decision-grade update. Instead, clinical activity for MPA has generally shifted toward:

• Formulation work (bioavailability, delivery systems, safety monitoring schedules)
• Comparative safety/real-world evidence in women’s health and HRT pathways
• Indication-specific studies in populations defined by regional practice guidelines

For market forecasting, the practical impact is that Provera’s demand drivers remain clinical standard-of-care and prescribing habits, not new randomized late-stage efficacy claims.

Clinical-trial implication for investors/R&D: absent a clearly identifiable, brand-relevant Phase 3 or registration-enabling program, the probability-weighted outlook for share gains comes primarily from pricing, supply reliability, and payer behavior, not from label expansion.

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How big is the market for Provera/MPA and what is the demand mix?

Provera is part of the broader progestin market and, within that, the medroxyprogesterone acetate segment. Demand is driven by four channels:

1. Menopausal HRT workflows (endometrial protection)
   • Prescribers select MPA-based regimens for endometrial protection paired with estrogen
2. Abnormal uterine bleeding and amenorrhea management
   • MPA is commonly used in hormonal workups and cyclic or episodic regimens
3. Endometriosis and related gynecologic indications
   • Role varies by guideline and region, with stronger competition from other hormonal agents
4. Oncology-adjacent progestin use (where applicable by label)
   • Often smaller relative share than HRT/gynecology in mainstream markets

Because MPA is older and widely generic, the market is characterized by:

• Low unit value versus newer biologics and hormonal agents
• High price erosion after generic entry
• Stability in volume tied to women’s health utilization rates and guideline adherence

Commercial constraint: Provera’s brand share is typically held by legacy penetration where brand loyalty persists or where payer formularies continue to list the originator.

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What is the competitive landscape versus modern progestins and generics?

Competition has three layers:

• Generic MPA products (same active ingredient, formulation-dependent interchangeability)
• Alternative progestins used for HRT endometrial protection and abnormal bleeding:
  • Examples include norethindrone derivatives, levonorgestrel-based products, and other oral progestins
• Non-progestin or procedure-based pathways:
  • For abnormal bleeding, increased use of levonorgestrel IUS and procedural interventions in some markets can reduce MPA share over time

Net effect: Provera competes mainly on net price and formulary placement, while clinical differentiation is limited once generics are available.

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Market projection: base case outlook for Provera/MPA through 2030

Because Provera is an MPA brand inside a mature, mostly generic therapeutic class, projections should be expressed as market value evolution driven by pricing and modest volume growth.

Scenario framework

• Base case (most likely):
  • Volume grows slowly with demographics and persistent guideline use
  • Value declines modestly or flat-to-slightly down due to ongoing generic price competition and tendering
• Downside:
  • Faster conversion to alternative progestins or IUS in abnormal bleeding indications
  • Aggressive payer rebates deepen erosion
• Upside:
  • Stable formulary position and pricing resilience in key geographies
  • Fewer supply disruptions and continued brand listing in HRT endometrial protection

What this means for forecasting

For a decision-grade projection, the relevant KPI is value CAGR, not label expansion. In mature generic hormonals:

• Value CAGR is typically negative to low-single digits over the medium term
• Volume CAGR is usually low-single digits at most, depending on demographic trends and practice patterns

Projection table (directional, decision-useful framing)

Metric	2024-2027	2028-2030	Primary driver
Market value (Provera/MPA brand-level where captured)	-2% to +1%	-1% to +1%	Generic pricing pressure and formulary rebates
Market value (total MPA class)	-1% to +2%	0% to +2%	Stable volume with mixed pricing outcomes
Prescription volume	+1% to +3%	+1% to +2%	Population aging and ongoing HRT/bleeding management
Share risk	Gradual downtrend	Moderate downtrend	Ongoing generic substitution and alternative progestins

This structure is aligned with how mature progestin segments behave under generic penetration and payer procurement.

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Are there patent or regulatory events that could move the forecast?

For Provera specifically, commercial upside usually requires one of the following:

• Brand-specific formulation or device exclusivity that meaningfully blocks substitution
• Regulatory actions that temporarily reduce generic supply
• Payer formulary shifts that maintain originator listing despite generics

For MPA broadly, the market is generally dominated by generic availability, which keeps value growth constrained.

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What is the investment or R&D implication for stakeholders?

For an originator brand with limited actionable late-stage development visibility, the most actionable paths are operational and commercial rather than clinical:

• Contracting strategy: target geographies where formularies keep originator access longer
• Portfolio defense: optimize gross-to-net via rebate and bundle structures
• Supply continuity: reduce channel disruption risk, which can cause abrupt share losses
• Product stewardship: maintain competitive positioning for key strengths in current label formats

If a company is underwriting an R&D thesis, the only realistic label-change thesis for a mature progestin would come from:

• A clearly differentiated formulation (improved adherence or safety profile)
• A new route/dosing paradigm with an evidence package accepted by regulators and payers Absent such signals, the base case remains pricing and share protection.

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Key Takeaways

• Provera (medroxyprogesterone acetate) is a mature, broadly generic progestin where brand value is constrained by substitution.
• Public clinical activity for MPA does not present a clear, brand-enabling late-stage signal that would materially re-rate Provera’s growth profile.
• Forecasting is driven by pricing erosion, formulary placement, and demographic utilization, not by label expansion.
• Through 2030, the most decision-consistent outlook is low growth in volume and flat-to-low negative value growth for brand-level economics, with total MPA class value remaining more stable due to volume offset.

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FAQs

1) What are Provera’s core commercial demand drivers?

HRT endometrial protection workflows, abnormal uterine bleeding and amenorrhea treatment pathways, and guideline-based gynecology prescribing where MPA remains a standard option.

2) Does Provera benefit from new clinical trial breakthroughs?

No clear, registration-enabling late-stage breakthroughs tied to Provera/MPA are evident in the public high-signal record that would justify a label-change-driven growth thesis.

3) How does generic competition affect Provera pricing?

Generic entrants typically compress net prices via formulary substitution and rebate pressure, driving value CAGR lower even when volume remains resilient.

4) What indications matter most to market value?

HRT endometrial protection and abnormal uterine bleeding/amenorrhea patterns tend to dominate utilization economics in most markets where MPA is prescribed.

5) What would change the projection materially?

A brand-specific formulation or regulatory event that restricts generic substitution, or payer shifts that restore/maintain originator listing despite generics.

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References

[1] FDA. Provera (medroxyprogesterone acetate) prescribing information. U.S. Food and Drug Administration.
[2] EMA. Provera: summary of product characteristics (SPC) or assessment documentation where available. European Medicines Agency.
[3] ClinicalTrials.gov. Medroxyprogesterone acetate search results and study listings. U.S. National Library of Medicine.
[4] WHO Collaborating Centre for Drug Statistics Methodology (or equivalent). ATC/DDD classification and utilization framework for MPA/progestins. World Health Organization.