CLINICAL TRIALS PROFILE FOR DEPO-PROVERA

All Clinical Trials for DEPO-PROVERA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00033358 ↗	Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2002-02-01	Randomized phase II trial to compare two different hormone therapy regimens in preventing endometrial cancer in women who have a genetic risk for hereditary nonpolyposis colon cancer. Hormone therapy may prevent the development of endometrial cancer in women with a genetic risk for hereditary nonpolyposis colon cancer. It is not yet known which hormone therapy regimen is more effective in preventing endometrial cancer.
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.
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.
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.

Clinical Trial Conditions for DEPO-PROVERA

Condition Name

Condition Name for DEPO-PROVERA
Intervention	Trials
Contraception	12
Dysfunctional Uterine Bleeding	3
HIV	3
HIV Infections	3

Condition MeSH

Condition MeSH for DEPO-PROVERA
Intervention	Trials
Hemorrhage	5
Metrorrhagia	4
Uterine Hemorrhage	4
Polycystic Ovary Syndrome	3

Clinical Trial Locations for DEPO-PROVERA

Trials by Country

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Trials by Country for DEPO-PROVERA
Location	Trials
United States	161
Dominican Republic	3
Puerto Rico	2
Zimbabwe	2
Norway	2

Trials by US State

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Trials by US State for DEPO-PROVERA
Location	Trials
California	13
Pennsylvania	11
Texas	8
Ohio	7
North Carolina	7

Clinical Trial Progress for DEPO-PROVERA

Clinical Trial Phase

Clinical Trial Phase for DEPO-PROVERA
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	6
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for DEPO-PROVERA
Clinical Trial Phase	Trials
Completed	37
Terminated	8
Recruiting	6

Clinical Trial Sponsors for DEPO-PROVERA

Sponsor Name

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

Sponsor Type

Sponsor Type for DEPO-PROVERA
Sponsor	Trials
Other	71
Industry	12
NIH	12

Depo-Provera: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

Depo-Provera, a long-acting reversible contraceptive containing medroxyprogesterone acetate (dMPA), has been a staple in reproductive health for decades. However, recent studies and legal developments have cast a new light on its safety and efficacy. Here, we delve into the latest clinical trials, market analysis, and future projections for Depo-Provera.

How Depo-Provera Works

Depo-Provera functions through several mechanisms to prevent pregnancy:

• Inhibition of Ovulation: Prevents the ovaries from releasing an egg.
• Thickening of Cervical Mucus: Makes it difficult for sperm to pass through the cervix.
• Thinning of the Uterine Lining: Reduces the likelihood of a fertilized egg implanting and developing.
• Effect on Sperm: Creates an environment less favorable for sperm survival and function[2][3].

Clinical Trials and Safety Concerns

Recent Studies on Brain Tumors

A significant study published in the journal Cancers in September 2024 revealed a troubling link between prolonged Depo-Provera use and an increased risk of developing cerebral meningiomas. This large-scale case-control study analyzed over 117,000 meningioma cases and more than one million matched controls, finding a 53% increase in the risk of developing meningiomas with prolonged use[1].

Spinal Tumors

Recent research has also focused on the risk of meningiomas forming on the spinal cord. Studies suggest that external hormone sources, such as Depo-Provera, may be linked to a higher risk of these tumors[2].

Bone Density Loss

Clinical studies have consistently shown that Depo-Provera use is associated with significant loss of bone mineral density (BMD), particularly during adolescence and early adulthood. This loss is more pronounced in the first two years of use and could increase the risk for osteoporotic fractures later in life[4][5].

Cancer Risks

Long-term case-controlled surveillance has found no overall increased risk of ovarian, liver, or cervical cancer. However, there is a slight increase in the risk of breast cancer, especially in women under 35 who were first exposed to the drug within the previous four years[3][5].

Market Analysis

Historical Context

Depo-Provera was originally developed in 1959 and approved by the FDA in 1974, only to have its approval withdrawn in 1978 due to cancer concerns. It was reapproved in 1992 as a contraceptive. This history of regulatory scrutiny has impacted its market perception[2].

Current Market Status

Despite the efficacy of Depo-Provera as a contraceptive, the recent studies linking it to brain tumors and other health risks have led to increased legal challenges and public concern. Pfizer, the current manufacturer, faces renewed legal pressure and potential lawsuits from users who claim the company failed to adequately warn about these risks[2].

Market Projections

Given the emerging evidence of health risks associated with Depo-Provera, the market for this drug is likely to decline. The anticipated rise in lawsuits and the growing public awareness of these risks will likely deter many potential users. Pharmaceutical companies may need to reconsider the long-term viability of Depo-Provera as a contraceptive option.

Legal Implications

Lawsuits and Litigation

Several lawsuits have been filed against Pfizer alleging that the company knew about the potential risks of Depo-Provera, including brain tumors and bone density loss, but failed to warn users. Notable cases include Cassandra Colville v. Pharmacia & Upjohn, which highlighted previous concerns about bone density loss[2].

Future Legal Challenges

With the recent studies providing stronger evidence of the link between Depo-Provera and brain tumors, the number of lawsuits is expected to increase. This could lead to significant financial and reputational costs for Pfizer and other involved parties.

Public Health Impact

User Awareness

The public health impact of Depo-Provera's safety concerns is significant. Users need to be aware of the potential risks, especially those considering long-term use. Healthcare providers must weigh the benefits against the risks and discuss these with patients.

Alternative Contraceptives

The market for alternative contraceptives is likely to see an increase as users seek safer options. This could drive innovation in the development of new, safer long-acting reversible contraceptives.

Key Takeaways

• Increased Risk of Brain Tumors: Prolonged use of Depo-Provera is linked to a higher risk of cerebral meningiomas and spinal tumors.
• Bone Density Loss: Significant loss of bone mineral density, particularly in younger users.
• Legal Challenges: Anticipated rise in lawsuits due to alleged failure to warn about health risks.
• Market Decline: Expected decline in market share due to growing public concern and legal issues.
• Public Health: Need for increased user awareness and consideration of alternative contraceptives.

FAQs

Q: What is Depo-Provera and how does it work?

A: Depo-Provera is a long-acting reversible contraceptive that works by preventing ovulation, thickening cervical mucus, thinning the uterine lining, and creating an environment less favorable for sperm survival and function.

Q: What are the recent health concerns associated with Depo-Provera?

A: Recent studies have linked prolonged Depo-Provera use to an increased risk of developing cerebral meningiomas and spinal tumors, as well as significant bone density loss.

Q: Are there any legal challenges facing Depo-Provera manufacturers?

A: Yes, Pfizer and other manufacturers are facing lawsuits alleging failure to warn about the potential health risks associated with Depo-Provera.

Q: How might these findings impact the market for Depo-Provera?

A: The market for Depo-Provera is likely to decline due to growing public concern and the anticipated rise in lawsuits.

Q: What alternatives are available for users concerned about Depo-Provera's safety?

A: Users can consider other long-acting reversible contraceptives such as intrauterine devices (IUDs), implants, or hormonal contraceptives that do not involve injectable hormones.

Sources

1. Anapol Weiss - September Study Links Prolonged Depo-Provera Use to Increased Risk of Brain Tumors
2. Robert King Law Firm - Depo-Provera Lawsuit - January 2025 Update
3. FDA - Depo-Provera® Contraceptive Injection
4. Pfizer Medical Information - DEPO-PROVERA® CI Clinical Studies
5. Pfizer Medical Information - DEPO-PROVERA® CI