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Progestin-only Contraceptive
ENG Implant for Birth Control
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Palpable intact ENG implant in the upper inner-arm for 36 months from the date of insertion at the time of enrollment, and has documentation of the insertion date (for example, Nexplanon user card or medical record completed on the date of insertion).
Not diagnosed with perimenopause or menopause.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months (from 3 years prior to study entry to 2 years after study entry)
Awards & highlights
Study Summary
This trial will assess the efficacy and safety of the etonogestrel contraceptive implant when used for 4-5 years.
Who is the study for?
This trial is for women in good health, not going through menopause, who have had regular menstrual cycles and a palpable ENG implant for 3 years. They must be sexually active with a fertile male partner and want contraception without using other methods. Participants should commit to the study's procedures and timeline.Check my eligibility
What is being tested?
The study tests if the Etonogestrel (ENG) contraceptive implant remains effective in preventing pregnancy during the fourth and fifth years of use. It currently has approval for three years, but this trial seeks to confirm its safety and efficacy beyond that period.See study design
What are the potential side effects?
While specific side effects are not listed here, typical ones associated with contraceptive implants may include irregular bleeding, headaches, breast tenderness, mood changes, weight gain, or local reactions at the implant site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a birth control implant in my arm for 3 years with proof of when it was put in.
Select...
I have not been diagnosed with perimenopause or menopause.
Select...
I have not been diagnosed with perimenopause or menopause.
Select...
I have a birth control implant in my arm for 3 years with proof of when it was put in.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 months (from 3 years prior to study entry to 2 years after study entry)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months (from 3 years prior to study entry to 2 years after study entry)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Who Discontinue Treatment (Implant Removed) Due to an Adverse Event During Extended-Duration Use
Number of Participants Who Experience One or More Adverse Events During Extended-Duration Use
Pregnancy Rate (Pearl Index) for Alternative At Risk Cycles During Extended-Duration Use
+1 moreSecondary outcome measures
Cumulative Pregnancy Rate During 4 Years of Implant Use
Cumulative Pregnancy Rate During 5 Years of Implant Use
Mean Length of Bleeding and/or Spotting Episodes During Extended-Duration Use as Assessed in 90-day Reference Periods
+13 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ENG implantExperimental Treatment1 Intervention
Participants will have the ENG 68 mg implant inserted and in place for 36 months before enrollment. The ENG implant will remain in place for an additional 24 months.
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Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,324 Total Patients Enrolled
Organon and CoLead Sponsor
491 Previous Clinical Trials
1,732,398 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,982 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had unexplained and frequent vaginal bleeding in the last year.I do not plan to become pregnant for the next 2 years and agree to use only the study's birth control method.I do not plan to become pregnant for the next 2 years and will not use other birth control methods.I haven't used hormonal contraceptives or sex hormone treatments in the last 3 months.I have a history of blood clots or certain heart and circulation problems.I have used a long-lasting injectable birth control in the last 9 months.I have used a 3-month injectable hormone therapy within the last 10 months.I haven't taken liver enzyme-inducing meds in the last 2 months.I have high blood pressure that is not well-managed.The person has had regular menstrual cycles of 21 to 35 days before the insertion of the ENG implant or before using hormonal contraceptives (which may have preceded the current implant use).I have a birth control implant in my arm for 3 years with proof of when it was put in.I have not treated my gonorrhea, chlamydia, trichomonas, or I have symptoms of vaginitis/cervicitis.I can follow the study's requirements and won't move during the study.I have not been diagnosed with perimenopause or menopause.You are in good overall health, both physically and mentally, according to the doctor's evaluation.I have had unexplained vaginal bleeding in the last year.I have a serious liver condition, like hepatitis or cirrhosis.I haven't had any cancer except skin cancer in the last 5 years.I have had cancer influenced by hormones, like breast or prostate cancer.I have or had liver tumors.I am not allergic to ENG implants or lidocaine with epinephrine.I haven't taken any experimental drugs in the last 2 months, except for COVID-19 treatment.I have not been diagnosed with perimenopause or menopause.I have a birth control implant in my arm for 3 years with proof of when it was put in.A heterosexual person who is sexually active, and is not aware of their partner's infertility, sterility, or subfertility, is seeking contraception in order to avoid pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: ENG implant
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Birth Control Patient Testimony for trial: Trial Name: NCT04626596 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA green-lit ENG implant use for medical procedures?
"There is both efficacy and safety data from multiple rounds of clinical trials, so Radiopaque Etonogestrel (ENG) Implant received a score of 3."
Answered by AI
Could you please list other times that Radiopaque Etonogestrel (ENG) Implant has been studied?
"Radiopaque Etonogestrel (ENG) Implant was first studied in 2011 by VL Medi Oy. As of now, there have been 44 completed trials and 9 ongoing studies. A notable amount of research is being conducted out of Portland, Oregon."
Answered by AI
How is Radiopaque Etonogestrel (ENG) Implant typically employed?
"Radiopaque Etonogestrel (ENG) Implant is an effective contraceptive solution for patients of reproductive age experiencing contraception-related issues."
Answered by AI
What other similar research projects preceded this one?
"Radiopaque Etonogestrel (ENG) Implant has been under research since 2011 when the first clinical trial, sponsored by Merck Sharp & Dohme LLC, occurred. After this initial study with 90 participants in 2011, Phase 4 drug approval was received and now there are 9 active studies involving Radiopaque Etonogestrel (ENG) Implant across 59 cities and 5 countries."
Answered by AI
What goals does this scientific research hope to achieve?
"The primary outcome of this study is the number of participants who experience one or more adverse events during extended-duration use, which will be evaluated over a period of up to 24 months. Secondary objectives include the pregnancy rate (Pearl Index) for at-risk cycles during 5 years of implant use, as well as the mean length of bleeding and/or spotting episodes during extended-duration use, both of which will be assessed in 90-day reference periods."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
California
Other
Texas
How old are they?
18 - 65
What site did they apply to?
Desert Star Family Planning ( Site 0193)
Matrix Clinical Research Inc ( Site 0105)
University of California Los Angeles ( Site 0119)
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
How long is a the study?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I’ve tried the iud and was forced to remove it due to pelvic pain. I’m hoping this contraception will help me.
PatientReceived no prior treatments
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