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
Polycystic Ovary Syndrome	3

Clinical Trial Locations for Provera

Trials by Country

Trials by Country for Provera
Location	Trials
United States	161
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	11
Texas	8
Ohio	7
North Carolina	7

Clinical Trial Progress for Provera

Clinical Trial Phase

Clinical Trial Phase for Provera
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	6
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Provera
Clinical Trial Phase	Trials
Completed	37
Terminated	8
Recruiting	6

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	71
Industry	12
NIH	12

Depo-Provera: Clinical Trials, Market Analysis, and Projections

Introduction

Depo-Provera, a widely used injectable contraceptive, has been a cornerstone in family planning for decades. However, recent developments have cast a shadow over its safety profile, particularly concerning its link to brain tumors. This article delves into the current clinical trials, market analysis, and future projections for Depo-Provera.

Clinical Trials and Safety Concerns

Bone Mineral Density Studies

Clinical studies on Depo-Provera have highlighted several safety concerns. For instance, long-term use of Depo-Provera has been associated with significant declines in bone mineral density (BMD). In a controlled clinical study, adult women using Depo-Provera for up to 5 years showed mean decreases in BMD of 5-6% compared to the control group. This decline was more pronounced in the first two years of use[3].

Adolescent Studies

In adolescent females (12 to 18 years of age), the use of Depo-Provera led to a significant decline in BMD, particularly at the total hip and femoral neck. The mean decrease in BMD at 240 weeks was more pronounced, indicating a potential long-term risk to bone health[3].

Brain Tumor Link

Recent scientific research has revealed a potential link between Depo-Provera use and the development of brain tumors, specifically intracranial meningiomas. The Roland study, a large-scale investigation, showed a staggering 555% increased risk of intracranial meningioma among long-term Depo-Provera users. This study has been a pivotal point in the ongoing litigation against Pfizer[4].

Litigation and Regulatory Updates

Bellwether Trials

The first bellwether trials in the Depo-Provera litigation are expected to begin in mid-2025. These trials will serve as test cases to gauge the strength of the plaintiffs' claims and could influence the outcomes of other lawsuits. A favorable outcome for plaintiffs could lead to substantial settlements[1].

Multidistrict Litigation (MDL)

A hearing on the proposed creation of a Depo-Provera MDL is scheduled for January 30, 2025. This decision, to be made by the Judicial Panel on Multidistrict Litigation (JPML), could consolidate numerous cases filed across various states, streamlining the legal process[1].

Prescribing Information Updates

Pfizer has updated the prescribing information for Depo-Provera to include risks associated with brain tumors, although the official warning label remains unchanged. This omission has raised concerns among medical professionals and patients about the transparency of potential risks[4].

Market Analysis and Projections

Market Size and Growth

The global injectable contraceptives market, dominated by Depo-Provera, was valued at USD 352.43 million in 2023 and is expected to reach USD 460.66 million by 2030, growing at a CAGR of 3.9%. Depo-Provera controlled about 60% of the global phase III progesterone-only injectable contraceptives market as of 2021[2].

Regional Dominance

North America is expected to dominate the injectable contraceptives market during the forecast period, driven by increasing awareness about family planning and the benefits of injectable contraceptives among women and healthcare providers[2].

Key Players

Major players in the injectable contraceptives market include Pfizer Inc., Merck & Co., Inc., Amphastar Pharmaceutical Inc., and Teva Pharmaceutical Industries Ltd. These companies are likely to influence market trends and respond to regulatory and litigation pressures[2].

Market Drivers and Restraints

The market is driven by factors such as increased awareness about family planning, government initiatives, and a rise in the number of sexually active women. However, safety concerns and potential litigation outcomes could act as restraints, affecting market growth and consumer confidence[5].

Impact of Safety Concerns on Market Projections

Potential Settlements and Litigation Costs

The ongoing litigation and potential settlements could significantly impact Pfizer's financials and the market's overall perception of Depo-Provera. Initial discussions about settlements have begun, and the outcomes of bellwether trials will be crucial in determining the future of these lawsuits[1].

Alternative Products

The existence of a safer alternative, Depo-SubQ Provera 104, which is a lower-dose subcutaneous injection, could further complicate the market landscape. This product, although not as widely studied for long-term neurological safety, presents a potentially safer option for consumers[4].

Consumer and Healthcare Provider Response

Awareness and Education

The updates to prescribing information and the growing body of research linking Depo-Provera to brain tumors have heightened awareness among healthcare providers and patients. This increased awareness could lead to a shift in prescribing practices and consumer preferences, potentially affecting market demand[4].

Alternative Contraceptives

The market for injectable contraceptives is not without alternatives. Other products, such as combined injectable contraceptives and short-acting injectable contraceptives, may see increased demand if safety concerns around Depo-Provera persist[5].

Key Takeaways

• Clinical Trials: Depo-Provera use is associated with significant declines in bone mineral density and a potential link to brain tumors.
• Litigation: Bellwether trials and the potential creation of an MDL could significantly impact the legal and financial landscape for Pfizer.
• Market Analysis: The injectable contraceptives market is projected to grow, but safety concerns and litigation could act as restraints.
• Consumer Response: Increased awareness and the availability of safer alternatives could influence consumer preferences and market demand.

FAQs

What are the key safety concerns associated with Depo-Provera?

Depo-Provera has been linked to significant declines in bone mineral density and a potential increased risk of brain tumors, specifically intracranial meningiomas.

What is the current status of the Depo-Provera litigation?

The first bellwether trials are expected to begin in mid-2025, and a hearing on the proposed creation of an MDL is scheduled for January 30, 2025.

How is the market for injectable contraceptives expected to grow?

The global injectable contraceptives market is expected to reach USD 460.66 million by 2030, growing at a CAGR of 3.9%.

Who are the major players in the injectable contraceptives market?

Major players include Pfizer Inc., Merck & Co., Inc., Amphastar Pharmaceutical Inc., and Teva Pharmaceutical Industries Ltd.

Is there a safer alternative to Depo-Provera?

Yes, Depo-SubQ Provera 104 is a lower-dose subcutaneous injection that is considered a safer alternative, although its long-term neurological safety is not as extensively studied.

Sources

1. Lawsuit Legal News: Depo Provera Lawsuit | January 2025 Update
2. Stellar Market Research: Injectable Contraceptives Market - Industry Analysis and Forecast
3. Pfizer Medical Information: DEPO-PROVERA ® CI Clinical Studies
4. Miller and Zois: Depo Provera Brain Tumor Lawsuits
5. Transparency Market Research: U.S. Injectable Contraceptives Market Research Report, 2031

Last updated: 2025-01-01