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Last Updated: June 14, 2025

CLINICAL TRIALS PROFILE FOR IMPLANON


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All Clinical Trials for Implanon

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00620464 ↗ A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(P05720) Completed Merck Sharp & Dohme Corp. Phase 3 2005-05-01 The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON.
NCT00725413 ↗ A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®)(P06473)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 4 2001-11-01 The primary purpose of this study is to investigate the contraceptive efficacy, safety and acceptability of Organon's subdermal etonogestrel implant in healthy female volunteers in various countries in order to obtain country-specific data.
NCT00828542 ↗ Safety of the Etonogestrel-releasing Implant During the Puerperium of Healthy Women Completed University of Sao Paulo N/A 2007-07-01 The purpose of this study to assess the safety of the etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate puerperium of healthy women.
NCT00847587 ↗ Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant Completed University of Utah Phase 4 2009-01-01 A highly effective single rod contraceptive implant is now available for use in the US. Delays in the insertion of the device until later in the postpartum period may negatively impact initiation rates. The objective of this study is to compare outcomes of early postpartum insertion (prior to postpartum hospital discharge) of the etonogestrel-releasing contraceptive implant with routine postpartum insertion at 4-8 weeks after delivery. Primary outcome of interest will be time to lactogenesis. Secondary outcomes will include rates of breastfeeding supplementation, infant growth, vaginal bleeding patterns, incidence of side effects, time to resume sexual intercourse after delivery, and incidence of missed routine postpartum follow-up. In addition, a subset of patients who randomize to early postpartum insertion will have expressed breastmilk ascertained for nutrient composition.
NCT00931827 ↗ Acceptability of Long-term Progestin-only Contraception in Europe Completed Bayer 2008-01-01 The study examines the use of Mirena or Implanon for long-term contraception in women. The duration of therapy use is the key focus of the study. Also, any reasons for discontinuation and the safety profile will be examined. In addition, patients are asked to fill out a short questionnaire about their menstrual bleeding before and during therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Implanon

Condition Name

Condition Name for Implanon
Intervention Trials
Contraception 11
HIV 3
Breastfeeding 2
Contraceptive; Complications, Intrauterine 1
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Condition MeSH

Condition MeSH for Implanon
Intervention Trials
Hemorrhage 4
Uterine Hemorrhage 3
Body Weight 1
Inflammation 1
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Clinical Trial Locations for Implanon

Trials by Country

Trials by Country for Implanon
Location Trials
United States 8
Brazil 5
Uganda 3
Thailand 2
Egypt 2
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Trials by US State

Trials by US State for Implanon
Location Trials
Virginia 1
South Carolina 1
Pennsylvania 1
Colorado 1
North Carolina 1
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Clinical Trial Progress for Implanon

Clinical Trial Phase

Clinical Trial Phase for Implanon
Clinical Trial Phase Trials
Phase 4 10
Phase 3 3
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Implanon
Clinical Trial Phase Trials
Completed 19
Unknown status 3
Terminated 1
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Clinical Trial Sponsors for Implanon

Sponsor Name

Sponsor Name for Implanon
Sponsor Trials
University of Pittsburgh 4
Merck Sharp & Dohme Corp. 3
Assiut University 2
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Sponsor Type

Sponsor Type for Implanon
Sponsor Trials
Other 36
Industry 5
U.S. Fed 1
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Implanon: A Comprehensive Review of Clinical Trials, Market Analysis, and Projections

Introduction

Implanon, a single-rod etonogestrel implant, is a highly effective long-acting reversible contraceptive method. This article delves into the clinical trials, market analysis, and future projections for Implanon, providing a thorough understanding of its efficacy, safety, market dynamics, and growth potential.

Clinical Trials and Efficacy

Overview of Clinical Studies

The efficacy and safety of Implanon were extensively evaluated in 11 international clinical trials involving 942 healthy women aged 18 to 40 years. These studies, conducted in various contraceptive clinics across the U.S., Chile, Asia, and Europe, demonstrated the implant's high efficacy and safety profile[1].

Efficacy Results

No pregnancies were reported during the use of the Implanon implant, highlighting its 100% efficacy in preventing pregnancies. The cumulative Pearl Index, a measure of contraceptive failure, was zero, indicating that Implanon is an extremely reliable contraceptive method[1].

Safety and Adverse Events

The safety of Implanon was assessed through the incidence of adverse events. While the majority of women completed the studies without significant issues, 13.6% discontinued due to adverse events other than bleeding irregularities, and 11.1% discontinued due to bleeding irregularities. Serious adverse events were rare, with no cases of deep vein thrombosis or myocardial infarction reported[1].

Bleeding Profile

The bleeding profile of Implanon was analyzed using reference period analyses. The studies showed that while some women experienced bleeding irregularities, these were generally manageable and did not significantly impact the overall satisfaction with the contraceptive method[1].

Market Analysis

Current Market Size

The subdermal contraceptive implants market, which includes Implanon, was valued at over USD 1.08 billion in 2024 and is projected to reach USD 1.73 billion by 2037, growing at a CAGR of 3.7% during the forecast period[2].

Growth Drivers

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

  • Rising Unintended Pregnancies: Globally, there are over 120 million unplanned pregnancies each year, making effective contraceptive methods like Implanon highly sought after[2].
  • Governmental Initiatives: Organizations such as the World Health Organization (WHO) are supporting nations in improving their contraceptive policies and developing new contraceptive methods, which boosts the market for subdermal implants[2].

Market Challenges

Despite the growth, the market faces challenges such as:

  • Adverse Events: Although rare, adverse events like bleeding irregularities can affect user satisfaction and retention.
  • Regulatory Hurdles: New products and formulations must navigate stringent regulatory approvals, which can slow market entry.

Future Projections

Market Growth

The subdermal contraceptive implants market is expected to continue growing, driven by increasing demand for effective and long-lasting contraceptive solutions. By 2037, the market is projected to reach USD 1.73 billion, indicating a steady and significant growth trajectory[2].

Technological Advancements

Future advancements in subdermal implant technology could further enhance the market. For example, the development of implants for other medical uses, such as the islatravir implant for HIV pre-exposure prophylaxis (PrEP), demonstrates the potential for expanded applications of subdermal implant technology[3].

Ongoing and Future Studies

Observational Studies

Ongoing observational studies, such as the "Keep Contraceptive Arm Long Acting-iMplant (CALM) and Carry On" study, are focusing on aspects like bleeding patterns before and after implant replacement. These studies aim to provide more detailed information to help clinicians counsel patients and improve user satisfaction[4].

Phase 2 Trials

The success of Phase 1 trials for new subdermal implants, such as the islatravir implant, is paving the way for Phase 2 trials. These trials will further explore the efficacy and safety of these implants, potentially leading to new long-acting options for various medical conditions[3].

Key Takeaways

  • High Efficacy: Implanon has demonstrated 100% efficacy in preventing pregnancies in clinical trials.
  • Safety Profile: While generally safe, Implanon can cause adverse events, with bleeding irregularities being the most common reason for discontinuation.
  • Market Growth: The subdermal contraceptive implants market is projected to grow significantly, driven by rising demand and governmental initiatives.
  • Future Advancements: Technological advancements and ongoing studies are expected to enhance the market and expand the applications of subdermal implants.

FAQs

What is Implanon?

Implanon is a single-rod etonogestrel implant, a long-acting reversible contraceptive method inserted under the skin of the upper arm.

How effective is Implanon?

Implanon is 100% effective in preventing pregnancies when used correctly, as demonstrated by clinical trials.

What are the common adverse events associated with Implanon?

Common adverse events include bleeding irregularities, with 11.1% of users discontinuing due to this reason. Other adverse events are rare but can include heart disorders, abdominal pain, and breast neoplasms.

What drives the growth of the subdermal contraceptive implants market?

The market growth is driven by the rising count of unintended pregnancies and governmental initiatives to improve contraceptive policies and develop new methods.

Are there ongoing studies to improve Implanon or similar implants?

Yes, ongoing observational studies and Phase 2 trials are focusing on improving our understanding of bleeding patterns and exploring new applications for subdermal implants.

What is the projected market size for subdermal contraceptive implants by 2037?

The market is projected to reach USD 1.73 billion by 2037, growing at a CAGR of 3.7% during the forecast period.

Sources

  1. Darney, P., et al. "Safety and efficacy of a single-rod etonogestrel implant (Implanon): results from 11 international clinical trials." Fertility and Sterility, 2008.
  2. Research Nester. "Subdermal Contraceptive Implants Market Size & Share." Research Nester, 2022.
  3. Merck. "Merck Presents Results from Phase 1 Trial Evaluating Islatravir Subdermal Implant for HIV Prevention." Business Wire, 2021.
  4. UCSD. "Keep Contraceptive Arm Long Acting-iMplant (CALM) and Carry On." ClinicalTrials.gov, 2024.
Last updated: 2025-01-07

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