New extended-use data supported a five-year approval for a contraceptive implant, with no on-treatment pregnancies reported during years four and five.
Long-acting reversible contraception (LARC), including IUDs and arm implants, offers pregnancy prevention that can last for years without a daily pill or monthly reminder. These methods are among the most effective reversible birth control options available.
Many patients want a method that fits their health needs, preferences and future plans. That makes evidence across body mass index (BMI) categories useful during contraceptive counseling.
In early 2026, the FDA extended the approved duration of use for an etonogestrel implant, 68 mg, from three years to five years. It is a small, flexible rod that sits under the skin of the upper arm.
In the Phase III extended-use study supporting the approval, no on-treatment pregnancies were reported during years four and five. The study also included women across a wide range of body weights, including just over 38% of participants with a BMI of 30 kg/m² or higher.
Director of Medical Affairs
Organon
Dr. Amy Taneja, MD, FACOG, Director of Medical Affairs at Organon and an OBGYN, spoke with Xtalks about how extended-use data support the etonogestrel implant as a five-year contraceptive implant option and why contraceptive research needs to include more types of patients.
How LARC Options Have Expanded
LARC options have changed a lot over time, with more choices available and different ways they can be placed. Today, patients may choose between options such as an arm implant or an IUD placed in the uterus, depending on their needs and preferences.
“The LARC space has continued to evolve since my initial training to include multiple options that previously had not been available to either HCPs or to patients,” stated Dr. Taneja.
Some LARC options can now be used over longer periods, giving patients and providers more flexibility when discussing pregnancy prevention goals.
“They can now be used for longer periods of time, and there are multiple different periods of time that patients could continue to utilize LARCs.”
“For patients in particular, choosing a birth control method is a highly personal decision.”
— Dr. Amy Taneja
Some LARC products may also help with health needs beyond birth control, such as heavy menstrual bleeding, depending on the product and the patient. This gives patients and providers more to discuss when choosing a method that fits a patient’s health needs and reproductive plans.
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Contraceptive Decisions Are Highly Personal
Choosing a birth control method is about more than how well it works. Medical history, current health, life circumstances, personal values and prior experiences with contraception can all shape the decision.
“For patients in particular choosing a birth control method, it’s a highly personal decision.”
Clinicians help explain which options may be appropriate, including safety, effectiveness and practical factors. But counseling also depends on the patient’s own understanding of their body, preferences and daily life.
“The patient is the expert in their own health and in their own body.”
When patients are considering longer-duration options, the conversation often includes duration of use, reversibility and future pregnancy plans. Cost, access, dosing schedule and fit with a patient’s routine can also guide the decision.
What the Extended-Use Data Adds
The FDA’s five-year approval of the etonogestrel implant was supported by an extended-use study in women who had already used the implant for three years and agreed to continue into years four and five.
“During this extended use period, no pregnancies were reported, and no safety findings were observed.”
BMI is also an important part of the data. Women enrolled in the trial had BMI values ranging from 17.2 to 64.3 kg/m², and just over 38% had a BMI of 30 kg/m² or higher.
Extended-use studies help clinicians and patients understand how a contraceptive method performs over time. In this case, the data provide evidence supporting use of the etonogestrel implant through five years, including among women with a range of body weights.
The findings may also help patients who prefer an arm implant over an IUD. Thinking about what feels acceptable and practical to them is a crucial aspect.
“We need to ensure that we are including the right mix and number of patients, whether those are patients with different ethnic backgrounds or patients who may have medical comorbidities.”
— Dr. Amy Taneja
Reading the Endpoints and Building Better Trials
Pregnancy rates and the Pearl Index are key measures in contraceptive trials. It is usually reported as the number of pregnancies per 100 women-years of use, which helps researchers compare effectiveness across methods and studies.
“Pearl Index has historically been a method by which we can simply quantify the effectiveness of various contraceptive methods.”
A lower Pearl Index indicates a more effective contraceptive method, while a higher number suggests a higher likelihood of unintended pregnancy. In the five-year contraceptive implant extended-use study, the Pearl Index was 0.00 pregnancies per 100 women-years during years four and five.
Dr. Taneja noted that the Pearl Index also has limitations. It can assume a constant failure rate over time and may not fully account for study dropouts or differences in the population enrolled.
Longer studies need enough participants, strong follow-up and study groups that reflect the patients who may use these products in real life.
“We need to ensure that we are including the right mix and number of patients, whether those are patients with different ethnic backgrounds, whether those are patients who may have medical comorbidities.”
Participants also need simple and intuitive ways to track and report their experiences.
The Next Questions in Long-Acting Contraception
Future contraceptive research may need to better reflect how healthcare is changing. One area of interest is the use of weight-loss management options, a population that has not always been well studied in contraceptive trials.
That includes patients with special health needs or complex medical conditions, who may require more individualized counseling but still need access to effective contraceptive options.
“It would be important to ensure that we have appropriate studies to evaluate the safety and efficacy of various contraceptive methods in those patients,” concluded Dr. Taneja.
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