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Progestin

Contraceptive Implant for Birth Control (NextOC2 Trial)

Phase 4
Recruiting
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 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

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 more

NextOC2 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
~170

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
910 Previous Clinical Trials
4,706,871 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,433 Total Patients Enrolled
University of PennsylvaniaOTHER
2,000 Previous Clinical Trials
42,879,968 Total Patients Enrolled

Media Library

Etonogestrel contraceptive implant (Progestin) Clinical Trial Eligibility Overview. Trial Name: NCT04423055 — Phase 4
Birth Control Research Study Groups: COC users or new starts
Birth Control Clinical Trial 2023: Etonogestrel contraceptive implant Highlights & Side Effects. Trial Name: NCT04423055 — Phase 4
Etonogestrel contraceptive implant (Progestin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04423055 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the recruitment capacity for this research endeavor?

"Indeed, the information found on clinicaltrials.gov indicates that this medical trial is actively seeking candidates. The study was first posted on August 13th 2020 with its most recent update being February 22nd 2022; it seeks 120 volunteers from 3 different sites."

Answered by AI

To what extent does Etonogestrel contraceptive implant help treat medical conditions?

"The etonogestrel contraceptive implant is a viable therapy for individuals of reproductive age looking to manage their contraception."

Answered by AI

Are there any historical precedents for the use of Etonogestrel implant in clinical trials?

"8 medical trials concerning the Etonogestrel contraceptive implant are being conducted, and one of them is in its third phase. Primarily based around Summerville, South carolina, these studies have a total of 162 sites running experiments."

Answered by AI

Is the recruitment phase of this experiment still open?

"Confirmed. The clinicaltrials.gov page for this trial indicates that it is actively recruiting participants, beginning on August 13th 2020 and last updated on February 22nd 2022. 120 individuals are being sought from 3 medical facilities."

Answered by AI

Have the regulatory authorities ratified Etonogestrel contraceptive implant?

"This form of contraception has been deemed safe by our team, and is therefore assigned a rating of 3. The approval status of this treatment as a Phase 4 trial attests to its safety in the public sphere."

Answered by AI

Is this experiment a pioneering endeavor?

"Since Merck Sharp & Dohme LLC's 2011 Phase 4 drug approval study, where 90 participants were involved to test the efficacy of Etonogestrel contraceptive implant, 44 additional studies have been conducted in 5 countries and 59 cities. These trials are still taking place today."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive
2020. "Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04423055.
~26 spots leftby Apr 2025
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