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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR NEXPLANON


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nexplanon

Condition Name

Condition Name for Nexplanon
Intervention Trials
Contraception 19
HIV 4
Immune Cells (Mucosal and Systemic) 2
Contraceptive; Complications, Intrauterine 1
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Condition MeSH

Condition MeSH for Nexplanon
Intervention Trials
Hemorrhage 5
Uterine Hemorrhage 3
Opioid-Related Disorders 1
Mucositis 1
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Clinical Trial Locations for Nexplanon

Trials by Country

Trials by Country for Nexplanon
Location Trials
United States 56
United Kingdom 5
Australia 4
Finland 2
Sweden 2
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Trials by US State

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

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

Sponsor Type for Nexplanon
Sponsor Trials
Other 40
Industry 9
NIH 3
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Nexplanon: Clinical Trials, Market Analysis, and Projections

Introduction to Nexplanon

Nexplanon, a long-acting, reversible, hormonal contraceptive implant, has been a significant player in the contraceptive market since its approval by the FDA in 2011. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

The Nexplanon Observational Risk Assessment (NORA) Study

The NORA study, a large prospective cohort study conducted in the United States, monitored pregnancy occurrence and outcomes among Nexplanon users in real-world clinical practice. The study involved 7364 participants recruited by healthcare professionals and followed up at 6-month intervals for 36 months and an additional 6 months after implant removal. The results indicated that Nexplanon is highly effective, with a Pearl Index of 0.04 (95% CI, 0.02-0.09) for pregnancies occurring during use or within 7 days following implant removal[1].

Extension Trial for Long-Term Use

An ongoing clinical trial is investigating the safety and efficacy of using the etonogestrel implant (Nexplanon) for more than the approved three years. This trial aims to determine if extended use is safe, continues to prevent pregnancy, affects menstrual cycles, and causes any issues during removal. Participants must have had the implant inserted 34–36 months ago and be willing to continue using it for an additional 24 months without other forms of contraception[3].

Mechanism of Action and Safety

Nexplanon works by inhibiting ovulation, thickening cervical mucus, and altering the endometrium to prevent pregnancy. It is a progestin-only contraceptive that does not contain estrogen and does not require daily, weekly, monthly, or quarterly administration. Common adverse reactions include changes in menstrual bleeding patterns, headache, vaginitis, weight increase, acne, breast pain, abdominal pain, and pharyngitis. It is also noted that Nexplanon may be less effective in very overweight women and those taking medications that induce liver enzymes[4].

Market Analysis

Current Market Size and Share

The subdermal contraceptive implants market, led by Nexplanon, was valued at over USD 1.08 billion in 2024. This market is expected to grow significantly, reaching USD 1.73 billion by the end of the forecast period. The North American market, particularly the United States and Canada, is predicted to account for the largest share, approximately 55% by 2037, driven by the availability and authorization of Nexplanon in these regions[2][5].

Regional Market Statistics

  • North America: Women in the US have access to over 50% of the contraceptive products available globally, compared to about 34% for Canadian women. The authorization of Nexplanon in Canada has expanded contraceptive options for women in the country[2][5].
  • APAC Market: While the APAC region is also growing, it lags behind North America in terms of market share and adoption of subdermal contraceptive implants.

Market Projections

Growth Drivers

The growth of the subdermal contraceptive implants market is driven by several factors:

  • Increasing Awareness: Greater awareness about long-acting reversible contraceptives (LARCs) is driving demand.
  • Availability and Authorization: The recent authorization of Nexplanon in Canada and its established presence in the US are key drivers.
  • Convenience and Efficacy: The convenience of a single-rod implant that provides up to three years of contraceptive protection without the need for daily or monthly administration is a significant advantage[2][5].

Future Outlook

By 2037, the subdermal contraceptive implants market is expected to continue its upward trend, with Nexplanon remaining a dominant player. The market size is projected to reach USD 1.73 billion, with North America maintaining its leading position. The expansion of contraceptive options in various regions and the ongoing clinical trials to extend the use of Nexplanon beyond three years will further solidify its position in the market[2][5].

Key Takeaways

  • Efficacy: Nexplanon has been proven highly effective in real-world use, with a low Pearl Index.
  • Safety: Common adverse reactions include changes in menstrual bleeding patterns and other minor side effects.
  • Market Size: The subdermal contraceptive implants market, led by Nexplanon, is valued at over USD 1.08 billion and is expected to grow to USD 1.73 billion by the end of the forecast period.
  • Regional Dominance: North America, particularly the US and Canada, will continue to dominate the market.
  • Future Outlook: Ongoing clinical trials and increasing awareness about LARCs will drive the market forward.

FAQs

What is Nexplanon and how does it work?

Nexplanon is a long-acting, reversible, hormonal contraceptive implant that works by inhibiting ovulation, thickening cervical mucus, and altering the endometrium to prevent pregnancy.

How effective is Nexplanon in preventing pregnancy?

Nexplanon is highly effective, with a Pearl Index of 0.04 (95% CI, 0.02-0.09) for pregnancies occurring during use or within 7 days following implant removal[1].

What are the common side effects of Nexplanon?

Common side effects include changes in menstrual bleeding patterns, headache, vaginitis, weight increase, acne, breast pain, abdominal pain, and pharyngitis[4].

Can Nexplanon be used during breastfeeding?

Nexplanon may be used during breastfeeding after the fourth postpartum week, but its use before this period has not been studied. Small amounts of etonogestrel are excreted in breast milk, but no significant effects on breast-fed infants have been observed[4].

Is Nexplanon available in countries other than the US?

Yes, Nexplanon is now authorized for use in Canada, providing Canadian women with an essential expansion of their contraceptive options[2][5].

Sources

  1. Final results from the Nexplanon Observational Risk Assessment ... - PubMed
  2. Subdermal Contraceptive Implants Market Share - Research Nester
  3. Nexplanon Extension Trial | BEACON Research Team - Boston University
  4. Merck Launches NEXPLANON® (etonogestrel implant) 68 mg in the ... - Merck
  5. Subdermal Contraceptive Implants Market Size & Share - Research Nester

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