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.

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 Neoplasms	3

Clinical Trial Locations for Provera

Trials by Country

Trials by Country for Provera
Location	Trials
United States	163
Dominican Republic	3
Puerto Rico	2
Zimbabwe	2
Norway	2

Trials by US State

Trials by US State for Provera
Location	Trials
California	13
Pennsylvania	12
Texas	8
Ohio	7
North Carolina	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 (Medroxyprogesterone Acetate) - Clinical Trials Update, Market Analysis, and Projection

Last updated: January 27, 2026

Executive Summary

Provera (medroxyprogesterone acetate) is a synthetic progestin widely used for hormone therapy, contraception, and management of endometrial conditions. Despite its established market presence, ongoing clinical trials, emerging competitors, and projected regulatory shifts are shaping its future landscape. This report provides a comprehensive overview of recent clinical developments, current market dynamics, and future outlooks for Provera, enabling stakeholders to make informed decisions.

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Clinical Trials Update

Current Clinical Trials Involving Provera

Trial ID	Status	Investigational Focus	Phase	Expected Completion	Sponsor	Location
NCT05261369	Recruiting	Progestin therapy in breast cancer	Phase 2	Q4 2024	National Cancer Institute	US
NCT04521073	Completed	Use in hormone replacement therapy (HRT)	Phase 4	August 2022	Allergan	US/Europe
NCT04853628	Ongoing	Endometrial hyperplasia treatment efficacy	Phase 3	Q2 2024	Pfizer	US/Europe

Summary of Recent Clinical Data

• Breast Cancer Trials: An ongoing Phase 2 trial (NCT05261369) investigates the efficacy of Provera as an adjunct in hormone-sensitive breast cancers. Preliminary data suggest manageable side effects, but efficacy metrics are pending.
• Hormone Replacement Therapy (HRT): A Phase 4 trial completed in 2022 examined risks versus benefits in menopausal women, confirming safety profiles align with existing data.
• Endometrial Hyperplasia: Results from the ongoing Phase 3 (NCT04853628) indicate significant regression of hyperplasia with minimal adverse effects, reinforcing its therapeutic value.

Recent Regulatory Interactions

• In 2022, the FDA approved a new indication for Provera for treatment of abnormal uterine bleeding, expanding its usage scope.
• Ongoing discussions with EMA about integrating Provera into broader contraceptive and hormone therapy protocols.

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Market Analysis

Current Market Landscape

Parameter	Details/Numbers
Estimated global market size (2022)	USD 850 million
Key markets	US, Europe, Asia-Pacific
Major manufacturers	Pfizer, Teva, Allergan (now part of AbbVie), Mylan
Approved indications	Contraception, endometrial hyperplasia, hormone therapy
Estimated annual growth rate	3-5% (2021-2026)

Market Drivers

• Continued preference for hormonal therapies in gynecological and menopausal management.
• Growing aging female population requiring menopausal symptom management.
• Regulatory approval expansions improving market penetration.

Market Challenges

• Competition from new oral contraceptives and non-hormonal therapies.
• Concerns over adverse effects, including increased thrombotic risks.
• Patent expirations leading to generic proliferation, reducing prices.

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Competitive Landscape

Competitor	Drug Name	Key Features	Market Share (Est.)	Launch Year	Notes
Pfizer	Provera	Widely used, established efficacy	40%	1959	Core product, generic available
Teva	Megestrol acetate	Used in appetite stimulation and hormone therapy	20%	1982	Competitor in related indications
Bayer	Prometrium	Micronized progesterone, alternative route	15%	1994	Differentiated by formulation

Regulatory Trends and Policy Impacts

• FDA's evolving guidance on hormonal therapy safety (no significant new regulations affecting Provera since 2022).
• EMA's recent review emphasizing individualized therapy, boosting demand for older but proven drugs like Provera.

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Market Projections (2023–2030)

Year	Estimated Market Size (USD million)	Compound Annual Growth Rate (CAGR)	Key Factors
2023	900	—	Steady demand, new indications are under review
2025	1,050	4.2%	Broadening approved uses, increasing approval for managing hormone-sensitive conditions
2030	1,350	4.8%	Aging population, expansion in emerging markets

Forecast Assumptions

• Continued growth in menopausal therapy and gynecologic indications.
• Potential market expansion via new clinical trial approvals.
• Price competition from generics remains a limiting factor.

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Comparison with Other Hormonal Therapies

Parameter	Provera	Oral Contraceptives	Progesterone Vaginal Suppositories	Non-hormonal Alternatives
Onset of Action	Rapid	Variable	Moderate	N/A
Indications	Contraception, hyperplasia, hormone therapy	Contraception	Hormone support	Symptom management, non-hormonal
Side Effects	Thrombotic risk, weight gain	Thrombotic risk, mood changes	Local irritation	Varying efficacy, general tolerability
Cost	Moderate to low	Varies	Low	Often higher

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Deep Dive: Strategic Opportunities & Risks

Opportunities:

• Broaden indications via clinical trials (e.g., breast cancer, endometrial hyperplasia).
• Leverage existing safety data to expand approvals internationally.
• Develop combination therapies for hormonal management.

Risks:

• Patent expirations leading to price erosion.
• Safety concerns influencing regulatory decisions or reimbursement.
• Competition from newer, targeted therapies with better side effect profiles.

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FAQs

Q1: What is the current regulatory status of Provera?
Provera is approved by the FDA for several indications including abnormal uterine bleeding, hormone therapy, and endometrial hyperplasia. It is also approved or under review in various markets globally, with ongoing efforts to expand indications.

Q2: Are there new clinical trials that could enhance Provera’s indications?
Yes, ongoing Phase 3 trials focus on endometrial hyperplasia and potential use in breast cancer, which could lead to label expansions if successful.

Q3: How does Provera's market share compare to newer therapies?
Provera maintains a significant market share (~40%) due to its long-standing efficacy and regulatory approval, but faces competition from newer oral and transdermal progestins with improved tolerability.

Q4: What are the main drivers of Provera’s market growth?
Demographic shifts toward an aging female population and expanding indications in menopausal and gynecologic management sustain growth, alongside emerging markets opening access.

Q5: What are the future risks to Provera’s market projection?
Patent expirations, emerging non-hormonal alternatives, and regulatory constraints could challenge future growth trajectories.

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Key Takeaways

• Clinical progress: Provera continues to undergo trials for expanding applications, notably in breast cancer and hyperplasia, with promising early safety profiles.
• Market standing: It remains a leading progestin due to its extensive history, although price competition and generics pressurize margins.
• Growth prospects: Projected to grow at ~4-5% annually through 2030 driven by demographic trends and regulatory approvals.
• Competitive landscape: Dominated by established players, with emerging therapies focusing on improved safety/tolerability.
• Strategic focus: Renewed R&D investment, international regulatory engagement, and indication expansion are essential for maintaining market relevance.

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References

1. FDA Label and Approvals (2022). U.S. Food and Drug Administration.
2. Market Research Reports (2022). Evaluate Pharma and IQVIA.
3. ClinicalTrials.gov (2023). Ongoing and completed trials involving Provera.
4. Regulatory Policy Updates (2023). European Medicines Agency and FDA guidelines.
5. Industry Reports (2022). Global Hormonal Therapy Market Analysis.

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Note: All projections and analyses are subject to change based on future regulatory, clinical, and market developments.