Last Updated: May 10, 2026

CLINICAL TRIALS PROFILE FOR DEPO-PROVERA


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All Clinical Trials for DEPO-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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

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

Trials by Country

Trials by Country for DEPO-PROVERA
Location Trials
United States 163
Dominican Republic 3
Puerto Rico 2
Zimbabwe 2
Norway 2
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Trials by US State

Trials by US State for DEPO-PROVERA
Location Trials
California 13
Pennsylvania 12
Texas 8
Ohio 7
North Carolina 7
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Clinical Trial Progress for DEPO-PROVERA

Clinical Trial Phase

Clinical Trial Phase for DEPO-PROVERA
Clinical Trial Phase Trials
PHASE4 1
Phase 4 13
Phase 3 6
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Clinical Trial Status

Clinical Trial Status for DEPO-PROVERA
Clinical Trial Phase Trials
Completed 37
Terminated 8
Recruiting 7
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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
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Sponsor Type

Sponsor Type for DEPO-PROVERA
Sponsor Trials
Other 74
NIH 13
Industry 12
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Depo-Provera: Clinical Trial Landscape, Market Dynamics, and Future Outlook

Last updated: February 19, 2026

Depo-Provera, a progestin-only injectable contraceptive, holds a significant position in the global reproductive health market. Its long-acting nature and established efficacy continue to drive its use, though evolving clinical trial landscapes and market competition necessitate ongoing analysis. This report details recent clinical trial activities, current market segmentation, and projected future trends for Depo-Provera.

What are the Latest Clinical Developments for Depo-Provera?

Recent clinical trial activity for Depo-Provera has primarily focused on evaluating its efficacy and safety in specific populations and exploring potential new delivery mechanisms or formulations. While the core technology is mature, research continues to refine its application and address unmet needs.

Ongoing and Completed Clinical Trials

A review of public clinical trial registries reveals a consistent, albeit moderate, level of activity surrounding Depo-Provera. Trials often focus on:

  • Comparative Efficacy Studies: Trials comparing Depo-Provera with other long-acting reversible contraceptives (LARCs), such as hormonal IUDs and subdermal implants. These studies aim to elucidate differences in effectiveness, side effect profiles, and user satisfaction.
  • Adolescent Populations: Research specifically examining the safety and efficacy of Depo-Provera in adolescent women, a demographic where consistent adherence to daily oral contraceptives can be challenging. These trials often assess bone mineral density changes, a known concern with progestin-only methods [1].
  • Long-Term Safety Monitoring: Post-marketing surveillance and observational studies continue to gather data on the long-term health outcomes of Depo-Provera users, particularly regarding cardiovascular health and bone density.
  • Formulation and Delivery Improvements: While less common, some exploratory research has investigated alternative delivery methods, though none have reached significant clinical trial stages for Depo-Provera itself.

Table 1: Key Depo-Provera Clinical Trial Focus Areas

Focus Area Description Status (General Trend)
Comparative Efficacy Head-to-head trials against other LARCs. Ongoing
Adolescent Safety Assessing bone mineral density and overall well-being in younger users. Ongoing
Long-Term Safety Real-world data collection on cardiovascular risk and other chronic conditions. Ongoing
Patient-Reported Outcomes Evaluating user satisfaction, convenience, and quality of life impacts. Ongoing
Reproductive Health Studies on return to fertility post-discontinuation. Ongoing

Regulatory Landscape and Approvals

Depo-Provera, manufactured by Pfizer (as Depo-Provera Contraceptive Injection), has been approved by regulatory bodies worldwide for decades. Its primary indication remains the prevention of pregnancy. Regulatory focus for established drugs like Depo-Provera typically shifts from initial approval to post-marketing surveillance and the evaluation of any new data that might alter its risk-benefit profile or lead to label updates. No major new indications or significant formulation approvals have been announced for Depo-Provera in the past five years.

What is the Current Market for Depo-Provera?

The market for Depo-Provera is characterized by its long-standing presence, established patient base, and competition from a growing array of contraceptive options. Market dynamics are influenced by healthcare policies, access to LARCs, and evolving patient preferences.

Market Segmentation

Depo-Provera's market can be segmented by:

  • Geography: Developed markets (North America, Europe) and emerging markets (Asia, Africa, Latin America) exhibit different adoption rates and competitive landscapes. Emerging markets often see higher utilization due to cost-effectiveness and challenges with consistent daily pill adherence.
  • End-User: The primary end-users are women of reproductive age. Within this, specific sub-segments include adolescents, women seeking long-term contraception, and those for whom oral contraceptives are contraindicated.
  • Healthcare Setting: Distribution occurs through both public health programs and private healthcare providers. Public health initiatives, particularly in low- and middle-income countries, play a crucial role in Depo-Provera's accessibility.

Table 2: Depo-Provera Market Characteristics by Region

Region Key Market Drivers Competitive Intensity Growth Potential
North America Established use, physician familiarity, managed care influence. Moderate Stable
Europe Similar to North America, with varying national healthcare policies. Moderate Stable
Asia Growing demand for LARCs, increasing healthcare access, cost sensitivity. Moderate to High Moderate
Africa High demand for effective contraception, reliance on public health programs. Moderate Moderate to High
Latin America Mix of public and private sector use, growing LARC adoption. Moderate Moderate

Competitive Landscape

Depo-Provera faces competition from a broad spectrum of contraceptive methods, including:

  • Other Injectables: Newer injectable formulations with potentially different side effect profiles or administration frequencies.
  • Intrauterine Devices (IUDs): Both hormonal (e.g., Mirena, Liletta) and non-hormonal (e.g., Paragard) IUDs, offering extended duration of use (3-10 years) and high efficacy.
  • Subdermal Implants: Hormonal implants (e.g., Nexplanon) providing up to three years of contraception, known for high efficacy and ease of use.
  • Oral Contraceptives: Daily pills, both combined and progestin-only, remain a widely used option due to familiarity and accessibility, despite adherence challenges.
  • Sterilization: Permanent methods, including tubal ligation and vasectomy, for individuals who have completed childbearing.

Depo-Provera's competitive advantages include its proven efficacy, long duration of action (approximately three months), and established safety profile. Its disadvantages often cited include potential side effects such as menstrual irregularities, weight gain, and the aforementioned bone mineral density concerns, which can limit its use in certain patient groups.

Table 3: Comparative Efficacy and Duration of Leading LARCs

Contraceptive Method Typical Use Effectiveness (%) Duration of Use Manufacturer (Example)
Depo-Provera Injection 99.0 3 months Pfizer
Nexplanon Implant 99.9 Up to 3 years Merck
Mirena IUD (Hormonal) 99.8 Up to 8 years Bayer
Liletta IUD (Hormonal) 99.7 Up to 8 years Allergan
Paragard IUD (Non-hormonal) 99.2 Up to 10 years Teva Pharmaceuticals

Note: Typical use effectiveness accounts for real-world adherence and usage patterns.

Market Size and Revenue

The global contraceptive market is substantial and growing. While specific revenue figures solely for Depo-Provera are not always publicly disclosed separately by manufacturers, it contributes to the broader hormonal contraceptive market, estimated to be worth tens of billions of dollars globally. The injectable segment, where Depo-Provera is a key player, represents a significant portion of this market, particularly in developing regions where it is often a first-line LARC option. Market growth is projected to continue, driven by increasing awareness of family planning, rising disposable incomes in emerging markets, and government initiatives promoting contraception.

What are the Market Projections for Depo-Provera?

The future market for Depo-Provera is likely to be characterized by sustained demand, particularly in emerging economies, balanced by increasing competition and evolving healthcare provider and patient preferences in developed markets.

Growth Drivers

  • Accessibility and Affordability: In many low- and middle-income countries, Depo-Provera remains one of the most accessible and affordable LARC options, supported by global health organizations and national family planning programs.
  • Simplicity of Use: The infrequent administration (every three months) appeals to users who struggle with daily pill adherence.
  • Established Track Record: Healthcare providers are familiar with Depo-Provera's efficacy and management of its side effects.
  • Population Growth: Continued global population growth in many regions drives demand for effective contraception.

Challenges and Restraints

  • Side Effect Concerns: Persistent concerns regarding weight gain, menstrual irregularities, and bone mineral density can lead to patient dissatisfaction and physician reluctance in prescribing for certain individuals.
  • Advancements in LARCs: The introduction of newer LARCs with potentially fewer side effects, longer durations of action (e.g., extended-duration IUDs), or different hormonal profiles offers competitive alternatives.
  • Patient Preference Shifts: Growing patient demand for highly personalized and reversible contraceptive options, coupled with increased awareness of hormonal side effects, may favor methods like IUDs and implants for some demographics.
  • Regulatory Scrutiny: While established, any emerging data suggesting significant safety concerns could lead to updated labeling and potential market contraction.

Projected Market Trends

  • Stable Demand in Emerging Markets: Depo-Provera is projected to maintain a strong market share in emerging economies where affordability and accessibility are paramount. Public health initiatives will remain a critical driver.
  • Market Erosion in Developed Markets: In North America and Europe, Depo-Provera may see a gradual market share decline as newer LARCs gain traction. However, it will likely retain a segment of users who prefer or tolerate it well.
  • Focus on Specific Populations: Continued research and marketing may target specific patient groups where Depo-Provera's benefits outweigh its risks, such as certain adolescents or individuals who cannot use estrogen-containing contraceptives.
  • Competition Intensification: The competitive landscape will continue to evolve, with ongoing innovation in LARC technologies. Generic competition for Depo-Provera, if it emerges in significant ways, could impact pricing but is less likely to alter its fundamental market position given its established brand.

The overall market for Depo-Provera is expected to demonstrate modest growth, primarily driven by its strong position in emerging markets. However, growth rates will likely be tempered by competition and evolving therapeutic preferences in developed regions.

Key Takeaways

  • Depo-Provera clinical trials continue to focus on comparative efficacy, adolescent safety, and long-term monitoring, with no major new formulations or indications in recent years.
  • The global contraceptive market is substantial, with Depo-Provera holding a significant share in the injectable segment, especially in emerging economies due to its accessibility and affordability.
  • Competition from IUDs and subdermal implants is intensifying, particularly in developed markets, due to perceived advantages in side effect profiles and duration of use.
  • Market projections indicate sustained demand in emerging markets driven by population growth and family planning initiatives, while developed markets may see a gradual erosion of market share.

Frequently Asked Questions

  1. What is the primary mechanism of action for Depo-Provera? Depo-Provera primarily prevents ovulation by suppressing the release of gonadotropins from the pituitary gland. It also thickens cervical mucus, hindering sperm penetration, and alters the endometrium, making it less receptive to implantation.
  2. What are the most common side effects associated with Depo-Provera? Common side effects include menstrual irregularities (e.g., irregular bleeding, amenorrhea), weight gain, headaches, and mood changes. A significant concern is potential temporary loss of bone mineral density, which is usually reversible upon discontinuation.
  3. How does Depo-Provera compare in effectiveness to other Long-Acting Reversible Contraceptives (LARCs)? Depo-Provera is highly effective, with typical use effectiveness rates around 99.0%. Other LARCs like hormonal IUDs and subdermal implants generally have similar or slightly higher typical use effectiveness rates and offer longer durations of action.
  4. Are there any specific patient populations for whom Depo-Provera is contraindicated? Depo-Provera is contraindicated in individuals with known or suspected pregnancy, unexplained vaginal bleeding, active thrombophlebitis or a history of these conditions, cerebrovascular disease, known breast cancer or history of breast cancer, or benign or malignant liver tumors. It should also be used with caution in patients with osteoporosis or risk factors for osteoporosis due to potential effects on bone mineral density.
  5. What is the expected return to fertility after discontinuing Depo-Provera? The return to fertility after discontinuing Depo-Provera can be variable. While some women may conceive within a few months, it can take up to 12 months or longer for ovulation and menstruation to resume for others.

Citations

[1] American College of Obstetricians and Gynecologists. (2017). Long-Acting Reversible Contraception: Implants and Intrauterine Devices. Practice Bulletin No. 185. Obstetrics & Gynecology, 130(4), e71-e81.

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