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Progestin
Contraceptive Implant for Birth Control (NextOC2 Trial)
Phase 4
Waitlist Available
Led By Melissa C Matulich, MD MAS
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
NextOC2 Trial Summary
This trial is testing whether a contraceptive implant is more effective than the pill in women who are already using birth control.
Who is the study for?
This trial is for women over 18 who are currently using combined oral contraceptives (COCs) or about to start them. It's not suitable for those with conditions that make COCs or contraceptive implants risky, anyone in another clinical trial recently, or within 2 weeks post-pregnancy.Check my eligibility
What is being tested?
The study tests the Nexplanon implant in women who choose COCs for birth control. Participants will receive the implant and be monitored for a year to see if they stick with it, return to COCs, use both, and to note any changes in bleeding patterns and adverse events.See study design
What are the potential side effects?
Possible side effects include irregular bleeding patterns, discomfort at the implant site, potential hormonal side effects similar to those of oral contraceptives such as mood swings, weight gain, headaches, acne or breast tenderness.
NextOC2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
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 Evaluating ENG Implant as Acceptable
Secondary outcome measures
Bleeding Patterns
Number of Participants Continuing COC
Number of Participants Evaluating ENG as Tolerable: Tolerability
+1 moreNextOC2 Trial Design
1Treatment groups
Experimental Treatment
Group I: COC users or new startsExperimental Treatment1 Intervention
Subjects will have an etonogestrel contraceptive implant placed at enrollment. Women using COC as method of contraception for at least 1 month will be considered COC users. Women using COC for less than 1 month will be considered new starts.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etonogestrel contraceptive implant
2010
Completed Phase 4
~290
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
914 Previous Clinical Trials
4,720,595 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,907 Previous Clinical Trials
5,065,916 Total Patients Enrolled
University of PennsylvaniaOTHER
2,016 Previous Clinical Trials
42,873,976 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman over 18 using or about to use birth control pills.I cannot use certain birth control methods due to health risks.I gave birth or ended a pregnancy less than 2 weeks ago.
Research Study Groups:
This trial has the following groups:- Group 1: COC users or new starts
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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