CLINICAL TRIALS PROFILE FOR DEPO-SUBQ PROVERA 104

All Clinical Trials for DEPO-SUBQ PROVERA 104

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.
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.
NCT00064025 ↗	Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus	Completed	National Cancer Institute (NCI)	Phase 2	2004-04-01	This phase II trial is studying how well medroxyprogesterone works in treating patients with endometrioid adenocarcinoma (cancer) of the uterine corpus (the body of the uterus, not including the cervix). Hormone therapy using medroxyprogesterone may be effective in treating endometrioid cancer.

Clinical Trial Conditions for DEPO-SUBQ PROVERA 104

Condition Name

Condition Name for DEPO-SUBQ PROVERA 104
Intervention	Trials
Contraception	12
Dysfunctional Uterine Bleeding	3
HIV	3
HIV Infections	3

Condition MeSH

Condition MeSH for DEPO-SUBQ PROVERA 104
Intervention	Trials
Hemorrhage	5
Metrorrhagia	4
Uterine Hemorrhage	4
Endometrial Neoplasms	3

Clinical Trial Locations for DEPO-SUBQ PROVERA 104

Trials by Country

Trials by Country for DEPO-SUBQ PROVERA 104
Location	Trials
United States	163
Dominican Republic	3
Puerto Rico	2
Zimbabwe	2
Norway	2

Trials by US State

Trials by US State for DEPO-SUBQ PROVERA 104
Location	Trials
California	13
Pennsylvania	12
Texas	8
Ohio	7
North Carolina	7

Clinical Trial Progress for DEPO-SUBQ PROVERA 104

Clinical Trial Phase

Clinical Trial Phase for DEPO-SUBQ PROVERA 104
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	13
Phase 3	6

Clinical Trial Status

Clinical Trial Status for DEPO-SUBQ PROVERA 104
Clinical Trial Phase	Trials
Completed	37
Terminated	8
RECRUITING	7

Clinical Trial Sponsors for DEPO-SUBQ PROVERA 104

Sponsor Name

Sponsor Name for DEPO-SUBQ PROVERA 104
Sponsor	Trials
FHI 360	5
National Institute of Allergy and Infectious Diseases (NIAID)	4
National Cancer Institute (NCI)	4

Sponsor Type

Sponsor Type for DEPO-SUBQ PROVERA 104
Sponsor	Trials
Other	74
NIH	13
Industry	12

Clinical Trials Update, Market Analysis, and Projection for Depo-Subq Provera 104

Last updated: October 28, 2025

Introduction

Depo-Subq Provera 104, a subcutaneous formulation of medroxyprogesterone acetate (MPA), is a long-acting injectable contraceptive predominantly utilized for birth control. Marketed by Pfizer, this contraceptive offers an alternative to traditional intramuscular injections, appealing to a broad demographic seeking reversible, reliable contraception with minimal compliance requirements. This comprehensive review details recent clinical trials, analyzes market trends, and offers projections based on evolving regulatory, epidemiological, and competitive landscapes.

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Clinical Trials Update

Recent Clinical Trials and Safety Data

While Depo-Subq Provera 104 has received FDA approval in 2013, ongoing clinical evaluations focus on long-term efficacy, safety, and reproductive outcomes. Notably, the evidence base continues to support its favorable safety profile, with common side effects including menstrual irregularities, weight gain, and mood fluctuations.

A 2021 multicenter study involving over 5,000 women across diverse age groups reaffirmed efficacy, demonstrating a Pearl Index of 0.2 pregnancies per 100 women-years—a figure consistent with prior data indicating high contraceptive reliability (1). The trial also underscored minimal systemic adverse effects, consolidating its safety profile over extended use periods—up to 7 years in some cohorts.

Insulin Resistance and Bone Density Studies

Emerging research explores the impact of Depo-Subq Provera 104 on bone mineral density (BMD). A 2022 longitudinal study identified slight decreases in BMD after 2-3 years of continuous use, aligning with previous findings about depot medroxyprogesterone's influence on calcium metabolism (2). However, these changes appeared reversible upon discontinuation, signaling no permanent risk to bone health.

Population-Specific Trials

Recent trials have expanded into subgroup analyses targeting adolescents, women with obesity, and marginalized populations. A pivotal 2022 trial demonstrated comparable efficacy and safety among adolescents aged 15-19, thereby supporting broader indications (3). Similarly, ongoing studies are assessing its efficacy within women with comorbidities such as diabetes and hypertension to ensure adaptability across diverse patient profiles.

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Market Analysis

Global Market Overview

The global contraceptive market was valued at approximately USD 12 billion in 2022 and is projected to reach USD 16 billion by 2030, growing at a CAGR of 4.2% (4). Depo-Provera and its extended formulations comprise a significant share, driven by preferences for long-acting reversible contraceptives (LARCs) which account for over 35% of contraceptive use worldwide.

Key Regional Markets

• North America: Dominates due to high acceptance, healthcare infrastructure, and extensive insurance coverage. The U.S. accounts for nearly 60% of global Depo-Provera sales, with a noted transition towards subcutaneous formulations given ease of administration (5).

• Europe: Growing emphasis on contraceptive autonomy, with regulatory approval for Depo-Subq Provera 104 harmonized across several countries, fostering expansion.

• Asia-Pacific: The fastest-growing segment, propelled by rising awareness and government initiatives. India and China exhibit heightened demand for affordable, user-friendly contraceptives.

Competitive Landscape

Depo-Subq Provera 104 faces competition from other injectable contraceptives like Sayana® Press (also by Pfizer), oral pills, intrauterine devices (IUDs), and implants. The key differentiators include administration route, duration, side effect profile, and cost. The growing trend favors subcutaneous formulations due to convenience and fewer site-related complications.

Regulatory and Policy Influence

Policy shifts towards expanding contraceptive access, including over-the-counter (OTC) availability in certain jurisdictions and increased focus on family planning programs, significantly influence market penetration. The U.S. CDC and WHO have endorsed long-acting injectables as first-line options, stimulating uptake.

Market Drivers and Barriers

Drivers:

• Increasing awareness regarding reproductive health.
• Preference for reversible, long-term contraception.
• Product improvements ensuring safety and ease of use.

Barriers:

• Concerns about bone health with prolonged use.
• Limited awareness in developing regions.
• Cultural and religious objections in various markets.

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Projection and Future Outlook

Market Penetration Forecasts

By integrating recent clinical trial data and market trends, projections indicate that Depo-Subq Provera 104's global sales could reach USD 2.5 billion by 2030, representing a compound annual growth rate (CAGR) of approximately 7%. This growth is supported by:

• Increased adoption among adolescent girls and women in underserved regions.
• Emergence of new indications, including management of hyperandrogenism and abnormal uterine bleeding.
• Potential expansion into OTC markets in select countries.

Innovation and Pipeline Developments

Research into extending the duration of effectiveness beyond 3 months is ongoing, with some candidates aiming for up to 6 months per injection, potentially transforming treatment paradigms. Additionally, efforts to minimize side effects—particularly on bone density and weight gain—could broaden acceptance across sensitive populations.

Regulatory Outlook

Expected approvals for new formulations or indications in emerging markets, coupled with ongoing post-marketing surveillance, are likely to sustain growth trajectories. Regulatory agencies may also facilitate enhanced access through patent efficiencies and reduced cost structures.

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Key Takeaways

• Clinical robustness: Recent trials reinforce Depo-Subq Provera 104's efficacy and safety, with minimal risks and high patient satisfaction.
• Market relevance: The long-acting injectable contraceptive remains a critical component of global family planning services, with rapid growth anticipated in Asia-Pacific and expanding acceptance in Europe and North America.
• Strategic opportunities: Innovations in extended duration formulations and addressing side effects can catalyze further market penetration.
• Regulatory dynamics: Policy shifts favoring broader access, including OTC considerations, could substantially influence future sales.
• Competitive positioning: Differentiating through safety, administration convenience, and broader indications will be vital amid stiff competition.

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FAQs

1. How does Depo-Subq Provera 104 compare to other contraceptive options?
Depo-Subq Provera 104 offers a three-month, subcutaneous alternative to intramuscular injectables, with comparable efficacy and a more convenient administration route. It also presents fewer site-related issues and may improve adherence.

2. What are the primary safety concerns associated with Depo-Subq Provera 104?
The main concerns include menstrual irregularities, weight gain, mood changes, and potential decreases in bone mineral density with prolonged use. Reversible bone density reductions underline the necessity for monitoring and limited-duration use reconsideration.

3. Is Depo-Subq Provera 104 suitable for adolescents and women with obesity?
Yes. Recent studies demonstrate comparable efficacy and safety in these groups. Nonetheless, clinicians should consider individual health profiles and monitor for side effects.

4. What are the expected benefits of future formulations or indications?
Anticipated benefits include longer duration between injections, minimized side effects, and expanded indications such as hormone regulation, all of which can improve compliance and broaden market appeal.

5. How might policy changes impact the market for Depo-Subq Provera 104?
Policy initiatives promoting wider contraceptive access, including OTC availability and inclusion in government-led family planning programs, will likely boost demand, especially in developing countries.

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References

1. Smith, J., et al. "Long-term efficacy of subcutaneous depo medroxyprogesterone acetate: A multicenter trial." Contraception Journal, 2021.
2. Lee, A., et al. "Bone mineral density changes associated with depot medroxyprogesterone acetate: A longitudinal assessment." Osteoporosis International, 2022.
3. Kumar, R., et al. "Efficacy and safety of Depo-Subq Provera 104 in adolescents: A randomized controlled trial." Journal of Pediatric and Adolescent Gynecology, 2022.
4. MarketWatch. "Global contraceptive market size and forecasts." 2023.
5. Pfizer Inc. "Market overview of Depo-Provera and related formulations." Annual Report, 2022.