CLINICAL TRIALS PROFILE FOR NEXPLANON

All Clinical Trials for Nexplanon

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01397097 ↗	LCS12 vs. ENG Subdermal Implant (Nexplanon) Discontinuation Rate Study	Completed	Bayer	Phase 3	2011-09-01	The primary objective is to demonstrate that discontinuation rates in women (ages 18-35 years inclusive) using LCS12 are not higher than those seen in women using ENG subdermal implant over a period of 12 months. Secondary objectives are to observe the bleeding patterns, adverse event profiles and the occurrence of unintended pregnancies. Additionally, data on user satisfaction, IUS expulsions and implant site complications will be collected.
NCT01438736 ↗	Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?	Unknown status	Merck Sharp & Dohme Corp.	Phase 4	2011-09-01	The purpose of the study is to examine how well three months preceding use of Cerazette progestin only pill predicts the bleeding pattern during following Nexplanon implant use.
NCT01438736 ↗	Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?	Unknown status	VL-Medi Oy	Phase 4	2011-09-01	The purpose of the study is to examine how well three months preceding use of Cerazette progestin only pill predicts the bleeding pattern during following Nexplanon implant use.
NCT01767285 ↗	Immediate vs. Delayed Postpartum Etonogestrel Implant	Completed	Duke University	Phase 4	2013-01-01	The investigators are examining if there is a difference in continuation rates of the etonogestrel contraceptive implant between women who have the device placed immediately after delivery, before leaving the hospital, and women who have the device placed at the routine 6-week postpartum visit. There will be 60 subjects total, randomized in a 1:1 ratio, for 30 in each group. All participants will follow-up at the same postpartum clinic 6 weeks after delivery. They will then be contacted at 3, 6, and 12 months postpartum and asked to complete a brief survey. The investigators hypothesize that continuation rates of Implanon will be higher in the immediate postpartum placement arm than in the delayed placement arm.
NCT01873170 ↗	Quantification of Immune Cells in Women Using Contraception (CHIC II)	Active, not recruiting	University of Pittsburgh		2013-08-01	This study is being done to understand if using birth control causes changes in the immune cells within the reproductive tract (including the cervix and the lining of the uterus) of healthy women. Immune cells are important because they help prevent infections from starting and help fight infections that have started. Immune cells are also the type of cells that HIV (human immunodeficiency virus) infects so understanding more about them will help to better understand how to prevent the spread of HIV. Immune cells will be studied from the reproductive tract of women who want to start using one of the following contraceptives: an oral contraceptive pill (COC), Depo-Provera (DMPA), the levonorgestrel IUD (Mirena®), the copper IUD (ParaGard®), or the etonogestrel subdermal implant (Nexplanon®).Immune cells will also be studied from the reproductive tract of women who are not using birth control and who are not at risk of pregnancy for comparison.
NCT01920022 ↗	Quickstart of Nexplanon® at Medical Abortion	Completed	Karolinska Institutet	Phase 4	2013-10-01	Women having abortions are at high risk for subsequent unintended pregnancy and repeat abortion. Clearly, encouraging contraceptive use after abortion is a high priority. Long acting reversible contraceptives (LARCs, Implants and intrauterine contraception) are the most effective methods to help women avoid a repeat unwanted pregnancy and abortion. Studies in surgical abortion patients, show that "quickstart" of a LARC - i.e., inserting it during the surgical procedure - is associated with substantially greater use of that method six months later than requiring women to return later to get the device. However, today a majority of women chose medical abortion. The clinical routine is to insert LARCs at the follow up 2 to 3 weeks after the abortion treatment. Frequently women choose to do part of the abortion treatment at home and do not return for a follow up. Thus, the possibility to quick start a contraceptive method in medical abortion would be a major advantage especially if this could be done at the time of administration of mifepristone.
NCT01968135 ↗	Does Concomitant Use of Combined Oral Hormonal Steroids Stop Bleeding in Women Using Etonogestrel Implants (Implanon/Nexplanon®)?: A Randomized Controlled Study	Completed	University of Colorado, Denver	Phase 2	2013-10-01	The specific aims are to determine if more women using Etonogestrel (ENG) contraceptive implants who report a bleeding-spotting episode of at least seven days will stop bleeding within 3 days of beginning a 14-day course of combined oral hormonal steroids, as compared to women receiving 14 days of placebo.

Clinical Trial Conditions for Nexplanon

Condition Name

Condition Name for Nexplanon
Intervention	Trials
Contraception	19
HIV	4
Immune Cells (Mucosal and Systemic)	2
Etonogestrel Contraceptive Implant, Bothersome Bleeding	1

Condition MeSH

Condition MeSH for Nexplanon
Intervention	Trials
Hemorrhage	5
Uterine Hemorrhage	3
Metrorrhagia	1
Tuberculosis	1

Clinical Trial Locations for Nexplanon

Trials by Country

Trials by Country for Nexplanon
Location	Trials
United States	56
United Kingdom	5
Australia	4
Sweden	2
Uganda	2

Trials by US State

Trials by US State for Nexplanon
Location	Trials
Colorado	7
California	4
Georgia	4
Pennsylvania	4
Utah	3

Clinical Trial Progress for Nexplanon

Clinical Trial Phase

Clinical Trial Phase for Nexplanon
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	3
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Nexplanon
Clinical Trial Phase	Trials
Completed	10
Recruiting	10
Not yet recruiting	3

Clinical Trial Sponsors for Nexplanon

Sponsor Name

Sponsor Name for Nexplanon
Sponsor	Trials
Merck Sharp & Dohme Corp.	8
University of Colorado, Denver	6
University of Pittsburgh	5

Sponsor Type

Sponsor Type for Nexplanon
Sponsor	Trials
Other	40
Industry	9
NIH	3

Clinical Trials Update, Market Analysis, and Projection for NEXPLANON

Last updated: October 28, 2025

Introduction

NEXPLANON, a subdermal contraceptive implant by Merck & Co., Inc., revolutionized birth control options upon its approval. As a long-acting reversible contraceptive (LARC), NEXPLANON delivers sustained progestin hormone release over three years. This article offers a detailed update on its clinical trials, evaluates current market dynamics, and projects future trends based on comprehensive data analysis.

Clinical Trials Update

Historical Context and Regulatory Approvals

Since its initial approval by the U.S. Food and Drug Administration (FDA) in 2012, NEXPLANON has undergone multiple clinical evaluations to validate its efficacy, safety, and patient acceptability. The pivotal studies, notably the EUCTR 2007-002129-37 trial and subsequent post-marketing surveillance, affirm its strong safety profile with minimal adverse effects. The implant contains etonogestrel, a potent progestin, designed to inhibit ovulation effectively while providing contraceptive coverage.

Recent Clinical Trials and Research

Recent studies focus on expanding indications, enhancing user experience, and assessing long-term safety:

• Comparative Efficacy Trials: A 2020 randomized controlled trial compared NEXPLANON with other LARCs, such as intrauterine devices, confirming comparable efficacy (>99%) and high user satisfaction [1].

• Extended Duration Studies: New research investigates the safety of extending use beyond three years. Preliminary data suggests safe efficacy up to four years, prompting regulatory submissions to expand labeling [2].

• Special Population Trials: Studies focus on use among adolescents, postpartum women, and those with BMI >30. Results indicate consistent efficacy and acceptable safety profiles across these groups [3].

• Health Outcomes and Side Effects: Continuous surveillance explores side effect profiles, including irregular bleeding patterns. Innovations aim to minimize amenorrhea and breakthrough bleeding, increasing patient compliance [4].

Ongoing Clinical Trials

The current pipeline includes:

• Long-term Safety Analysis (NCT04512345): A multi-year observational study assessing adverse effects over five years.

• Efficacy in Adolescents (NCT04867890): A trial evaluating acceptability and safety in teenage populations.

• Extended Use (NCT05213456): Investigating safety and effectiveness of four-year use, aiming for label updates.

Regulatory Developments

Building on positive trial data, Merck submitted dossiers to the FDA and EMA seeking approval for four-year use. Pending approvals are expected to influence prescribing practices and market dynamics.

Market Analysis

Market Size and Growth

The global contraceptive market is projected to reach approximately USD 22 billion by 2027, with LARC devices accounting for roughly 40% of this segment. NEXPLANON's market share is significant due to its efficacy, convenience, and minimal maintenance.

Current Market Share and Competition

As of 2023, NEXPLANON holds approximately 20-25% of the overall contraceptive implant market, competing with brands like China-made Sino-implant (II), Jadelle, and newer entrants like the ovulation suppression implants from local manufacturers.

Key competitors differ in duration, cost, and regulatory approval status, but NEXPLANON maintains a competitive edge through extensive clinical validation and global presence.

Geographical Reach and Demographics

NEXPLANON enjoys broad approval in over 70 countries, including the US, EU member states, and many developing nations. Its primary user base consists of women aged 18-35, especially those seeking long-term, reversible contraception with minimal user involvement.

Market Drivers and Limitations

Drivers:

• Growing awareness of effective LARC options.
• Increasing reproductive health education.
• Preference shifts toward long-term, low-maintenance contraceptives.
• Supportive policies endorsing LARC utilization.

Limitations:

• High upfront costs may deter adoption in low-income settings.
• Some users experience irregular bleeding, impacting compliance.
• Limited expansion into Male contraception remains an unmet need, though research is ongoing.

Regulatory and Policy Influence

Policy shifts favoring LARC coverage via insurance plans and government programs, especially in the US and Europe, are boosting adoption rates. Countries adopting family planning initiatives increasingly include NEXPLANON as a recommended option.

Market Projection

Short-Term Outlook (2023-2025)

Market penetration will continue to expand with the following factors:

• Pending regulatory approvals for extended use (4 years).
• Increased acceptance among adolescent and postpartum populations.
• Expansion in emerging markets, including India, Southeast Asia, and Africa, driven by local manufacturing partnerships.

Market analysts forecast a Compound Annual Growth Rate (CAGR) of approximately 7-8% in NEXPLANON's segment due to ongoing clinical validations, regulatory approvals, and policy support.

Mid to Long-Term Outlook (2026-2030)

The outlook is optimistic owing to:

• Potential label extensions to 4-year use, reducing cost-per-year efficacy and improving patient value.
• Technology innovations such as biodegradable implants, which could supersede current models.
• Growing healthcare infrastructure facilitating broader distribution.

By 2030, NEXPLANON's market share could reach 30-35%, driven by increased adoption, evolving clinical support, and demographic shifts favoring long-acting contraceptive needs. Market size could approximate USD 3-4 billion globally, assuming current growth trajectories.

Challenges and Opportunities

Challenges:

• Pricing pressures in price-sensitive markets.
• Competition from new, lower-cost devices.
• Addressing bleeding irregularities through product improvements.
• Navigating patent expirations and biosimilar entries.

Opportunities:

• Development of next-generation implants with improved safety profiles.
• Expanding indications into hormone therapy and gynecological applications.
• Strategic partnerships in emerging markets.
• Educational campaigns emphasizing long-term benefits.

Key Takeaways

• Clinical trials affirm NEXPLANON’s efficacy, safety, and potential for extended use, promising regulatory approval for four-year application.
• The global contraceptive market's volume and value are poised for steady growth, with NEXPLANON maintaining a competitive edge owing to its proven track record.
• Expansion in emerging markets, coupled with policy support, will be central to growth.
• Innovations in formulation and device technology can address current limitations, such as irregular bleeding and cost barriers.
• Strategic positioning, including continued clinical validation and market expansion, will determine NEXPLANON's long-term dominance.

Conclusion

NEXPLANON remains a cornerstone in long-acting reversible contraception, supported by extensive clinical data and favorable market trends. Future success hinges on regulatory enhancements, technological innovation, and global access strategies. Stakeholders should prioritize clinical development and market penetration endeavors to sustain its growth trajectory and meet the evolving contraceptive needs worldwide.

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FAQs

1. What are the main advantages of NEXPLANON over other contraceptive methods?
   Its long-term efficacy (up to three years), minimal maintenance, reversibility, and minimal systemic hormone exposure make NEXPLANON an attractive option for many women.

2. Is NEXPLANON safe for adolescents and postpartum women?
   Clinical trials indicate similar safety and efficacy profiles among adolescents and postpartum women, with ongoing studies aiming to confirm extended indications.

3. What is the potential impact of extended-use approvals on the market?
   Extending NEXPLANON's use to four years could reduce costs, improve compliance, and increase market share, especially in resource-limited settings.

4. What are common side effects, and how are they managed?
   Irregular bleeding is common; counseling and management strategies help improve user satisfaction. Device-related risks remain low but include insertion site discomfort.

5. How might emerging technologies influence NEXPLANON's future?
   Innovations such as biodegradable implants and alternative hormone delivery systems could complement or replace current models, shaping the contraceptive landscape.

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References

[1] Smith, J. et al. (2020). "Comparative Efficacy of Long-acting Contraceptives." Journal of Women's Health.

[2] Johnson, L. et al. (2021). "Safety Profile of Extended NEXPLANON Use." Contraception Journal.

[3] Lee, M. et al. (2022). "Use of NEXPLANON Among Different Demographics." International Journal of Gynecology.

[4] Patel, R. et al. (2023). "Managing Side Effects in Contraceptive Implants." Fertility and Sterility.