Study Summary
This trial will assess the efficacy and safety of the etonogestrel contraceptive implant when used for 4-5 years.
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
4 Primary · 16 Secondary · Reporting Duration: Up to 48 months (From 3 years prior to study entry to 1 year after study entry)
Up to 12 months
Pregnancy Rate (Pearl Index) for At Risk Cycles During Year 4 of Implant Use
Pregnancy Rate (Pearl Index) for At Risk Cycles During Year 5 of Implant Use
Up to 24 months
Mean Length of Bleeding and/or Spotting Episodes During Extended-Duration Use as Assessed in 90-day Reference Periods
Hemorrhage
Number of Bleeding and/or Spotting Days During Extended-Duration Use as Assessed in 90-day Reference Periods
Number of Complications Associated with Implant Removal
Number of Spotting Days During Extended-Duration Use as Assessed in 90-day Reference Periods
Percentage of Participants per 90-Day Reference Period with Frequent Bleeding and/or Spotting During Extended-Duration Use
Percentage of Participants per 90-Day Reference Period with Infrequent Bleeding and/or Spotting During Extended-Duration Use
Percentage of Participants per 90-Day Reference Period with Normal Frequency Bleeding and/or Spotting During Extended-Duration Use
Percentage of Participants per 90-Day Reference Period with Prolonged Bleeding and/or Spotting During Extended-Duration Use
Percentage of Participants per 90-day Reference Period with Amenorrhea During Extended-Duration Use
Pregnancy Rate (Pearl Index) for Alternative At Risk Cycles During Extended-Duration Use
Erythrocyte Indices
Year 3
Cumulative Pregnancy Rate During 4 Years of Implant Use
Year 3
Cumulative Pregnancy Rate During 5 Years of Implant Use
Pregnancy Rate (Pearl Index) for Alternative At Risk Cycles During 5 Years of Implant Use
Pregnancy Rate (Pearl Index) for At Risk Cycles During 5 Years of Implant Use
Month 24
Number of Participants Who Discontinue Treatment (Implant Removed) Due to an Adverse Event During Extended-Duration Use
Month 27
Number of Participants Who Experience One or More Adverse Events During Extended-Duration Use
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
1 Treatment Group
ENG implant
1 of 1
Experimental Treatment
495 Total Participants · 1 Treatment Group
Primary Treatment: Radiopaque Etonogestrel (ENG) Implant · No Placebo Group · Phase 3
ENG implant
Drug
Experimental Group · 1 Intervention: Radiopaque Etonogestrel (ENG) Implant · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 48 months (from 3 years prior to study entry to 1 year after study entry)
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,577,864 Total Patients Enrolled
Organon and CoLead Sponsor
489 Previous Clinical Trials
1,731,684 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,635 Previous Clinical Trials
7,940,732 Total Patients Enrolled
Eligibility Criteria
Age < 65 · Female Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you: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.
A Palpable intact ENG implant in the upper inner-arm for 36 months from the date of insertion.
Does not want to get pregnant within the next two years, is willing to use the implant for another two years, and does not plan to use any other form of contraception during that time.
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 haven't been diagnosed with perimenopause or menopause.
The participant is able and willing to adhere to all required study procedures, including study visits and eDiary entries, and does not plan to relocate during the study.
The investigator has judged that the person has good physical and mental health.
Who else is applying?
What state do they live in?
| Texas | 50.0% |
| California | 25.0% |
| Arizona | 12.5% |
| Other | 12.5% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Desert Star Family Planning ( Site 0193) | 20.0% |
| University of California Los Angeles ( Site 0119) | 20.0% |
| Oregon Health Sciences University Hospital ( Site 0128) | 20.0% |
| Other | 40.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 83.3% |
| Did not meet criteria | 16.7% |
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."
What questions have other patients asked about this trial?
- "How long is a the study?"
How many prior treatments have patients received?
| 0 | 100.0% |
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Conditions
Cancer Related
Treatments