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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

Must not have

Women who have contraindications to using a COC or a contraceptive implant (Category 3 or 4 in the CDC Medical Eligibility Criteria [MEC])

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot use certain birth control methods due to health risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Evaluating ENG Implant as Acceptable

Secondary study objectives

Bleeding Patterns

Number of Participants Continuing COC

Number of Participants Evaluating ENG as Tolerable: Tolerability

+1 more

Awards & Highlights

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.

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

0 / 1Eligibility criteria met