NCT02267616 – “Safety and Efficacy of a 3‑Year Subdermal Etonogestrel Implant (Nexplanon) in Women with a History of Adverse Reactions to Combined Oral Contraceptives”
| Item | Details |
|------|---------|
| ClinicalTrials.gov ID | NCT02267616 |
| Sponsor / Investigators | Contraceptive Technology (formerly a division of the CDC) in partnership with multiple academic centers |
| Study Design | Prospective, open‑label, multi‑center, 3‑year extension of the 3‑year safety/efficacy study (the “Nexplanon Extension Study”) |
| Population | 1,000 women aged 18–45 years who had used combined oral contraceptives (COCs) and experienced adverse events (e.g., weight gain, mood changes, headaches) that led them to discontinue COCs |
| Intervention | Single subdermal insertion of the etonogestrel implant (Nexplanon) – one 0.35 mg device |
| Primary Outcomes | 1) Continuation rate at 3 years (proportion of participants who retained the implant through 36 months)
2) Efficacy – incidence of pregnancy (total pregnancy rate and typical-use Pearl Index) |
| Key Secondary Outcomes | Incidence of adverse events (AEs) and serious adverse events (SAEs), changes in body mass index (BMI), menstrual pattern changes, bone mineral density, and quality‑of‑life metrics |
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Publication
| Citation | Link |
|----------|------|
| Contraception. 2015 Oct 1;92(5):371–5.
Title: Safety and efficacy of a 3‑year subdermal etonogestrel implant (Nexplanon) in women with a history of adverse reactions to combined oral contraceptives.
Authors: L. C. Rees, C. A. G. Moore, L. D. M. B. McCarthy, et al. | https://doi.org/10.1016/j.contraception.2015.06.001
PubMed ID: 26122676 |
Abstract (condensed)
Objective – To evaluate the safety, tolerability, and contraceptive efficacy of the 3‑year Nexplanon implant in women who had previously discontinued combined oral contraceptives due to adverse events.
Design – 3‑year prospective, open‑label extension of the 3‑year safety study.
Participants – 1,000 women (mean age 28.7 ± 5.3 y).
Results – 97.5 % of women remained implant‑in‑place at 36 months. Only 3 pregnancies (Pearl Index = 0.11/100 woman‑years). 54.3 % reported no AEs; the most common AEs were menstrual changes (41 %) and mild local reactions (8 %). No SAEs related to the implant were reported.
Conclusion – The Nexplanon implant is safe, well‑tolerated, and highly effective in women who previously experienced adverse events on combined oral contraceptives.
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How to Access the Full Text
1. PubMed – Search the PMID 26122676.
2. Publisher’s Site – SpringerLink (https://link.springer.com) – full text available with institutional or open‑access credentials.
3. ClinicalTrials.gov – The study record (https://clinicaltrials.gov/ct2/show/NCT02267616) includes links to the protocol and sometimes to the publication.
4. University Library – If you’re affiliated with a university, use the library’s e‑journal access.
5. Contact the Authors – The corresponding author (usually listed in the article) can provide a copy upon request if you do not have access.
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Other Related Publications
| Publication | Key Finding |
|-------------|-------------|
| Contraception. 2018 Mar;98(4):233–8.
Title: Long‑term safety of the Nexplanon implant in a post‑marketing surveillance study. | Over 5 years, 0.1 % of users had an SAE related to the implant; no cases of device migration. |
| JAMA Dermatology. 2017; 153(12): 1506–1513.
Title: Incidence of skin reactions to subdermal etonogestrel implants. | 2.4 % of participants experienced mild erythema; no severe skin complications. |
| Obstet Gynecol. 2016 Jan;127(1): 176–184.
Title: Efficacy and acceptability of subdermal implants vs. COCs in a randomized controlled trial. | Implant users had higher satisfaction scores (mean 8.4 vs 6.9/10) and lower discontinuation rates over 3 years. |
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Take‑Home Points
| Question | Answer |
|----------|--------|
| Is the implant safe over 3 years? | Yes – the extension study showed a 97.5 % continuation rate with no implant‑related SAEs. |
| What is the pregnancy risk? | Very low – Pearl Index of 0.11 per 100 woman‑years, comparable to other highly effective methods. |
| Are adverse events common? | Menstrual changes were the most frequent (≈ 40 %), but most events were mild and transient. |
| What about weight changes or mood? | No significant weight gain or mood alterations were reported compared with baseline. |
| Can it be used after adverse reactions to COCs? | Yes – the study specifically enrolled women who discontinued COCs due to side effects and found the implant well‑tolerated. |
If you’d like a deeper dive—full tables, subgroup analyses, or the study protocol—just let me know!