Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive (NextOC2)

Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive: a Multicenter Trial

Women currently using or starting a combined oral contraceptive (COC) will be offered study enrollment. Study subjects will have a Nexplanon placed and followed for approximately 12 months to evaluate if they continue the implant, the COC, or both, and to assess bleeding patterns and adverse events.

Study Overview

• Status: Recruiting
• Conditions: Contraception
• Intervention / Treatment: Drug: Etonogestrel contraceptive implant

Detailed Description

This study will be conducted at three sites across the United States: University of California, Davis, University of Colorado and University of Pennsylvania. Investigators will recruit women currently using COCs or intending to initiate COCs for pregnancy prevention. Each site will recruit approximately 40 women for a total of 120 subjects.

Visit 1:

Informed consent will be obtained. As part of informed consent, subjects will be educated that there is little data available on the adverse effects of combined COC and ENG implant use. The consent form will include a standardized description of the side effects and bleeding profile of COCs and the implant. Subjects will also need to review the package label information for Nexplanon and sign the FDA-required Nexplanon consent. After obtaining informed consent, subjects will be screened for entry criteria. Medical history will be obtained. A urine pregnancy test will be performed. Eligible subjects will have a Nexplanon contraceptive implant placed. A diary will be dispensed for the subject to document daily bleeding, COC use and adverse events.

Follow-up:

Follow up contact will be at approximately 4, 12, 26 and 39 weeks with the exit visit scheduled at 52 weeks.

At each follow up contact, the diary will be reviewed. Adverse events will be determined by inquiry and diary review. The subject will inform the study staff if she is using her COC and if she wants to continue use of her COC and ENG implant. The ENG implant will be removed upon request at any time during the study.

Study participation will be complete after the 52 week (~ 12 month) exit visit.

No blood draws will occur during this study.

A diary will be used but no surveys will be used.

Data to be collected by study staff include demographics, past medical and gynecologic history, prior and current contraceptive use.

Because women are being enrolled who are already currently using COCs or who plan to start COCs, the COC is not a study drug. The study intervention (study drug) is the contraceptive implant. The systemic hormone exposure with a contraceptive implant is minimal relative to a COC. The investigators do not expect any increase in side effects by adding a contraceptive implant to COC users. Of note, the primary risk with COC use is related to the estrogen which can increase the risk of venous thromboembolic disease. The implant has no estrogen. All products being used in the study are FDA-approved for contraception.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Melissa C Matulich, MD MAS; Phone Number: 916-734-6670; Email: mcmatulich@ucdavis.edu
• Study Contact Backup: Name: Courtney B Overstreet, BS; Phone Number: 916-734-6846; Email: cboverstreet@ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California, Davis
      • Contact: Melissa C Matulich, MD MAS; Phone Number: 916-734-6670; Email: mcmatulich@ucdavis.edu
      • Contact: Courtney B Overstreet, BS; Phone Number: 916-734-6846; Email: hs-obgynresearch@ucdavis.edu
      • Principal Investigator: Melissa C Matulich, MD MAS
  • Colorado
    • Denver, Colorado, United States, 80045
      • Recruiting
      • University of Colorado
      • Contact: Rebecca H Cohen, MD MPH; Phone Number: 303-724-2015; Email: rebecca.h.cohen@cuanschutz.edu
      • Principal Investigator: Rebecca H Cohen, MD MPH
      • Contact: Eva Dindinger, MPH; Phone Number: 303-724-8482; Email: Eva.Dindinger@CUAnschutz.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Andrea Roe, MD MPH; Phone Number: 267-254-0225; Email: andrea.roe@pennmedicine.upenn.edu
      • Contact: Arden McAllister, MPH; Phone Number: 215-662-3532; Email: arden.mcallister@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women 18 years and older currently using COCs or who have a COC prescription and are intending to initiate COCs for contraception

Exclusion Criteria:

• Women who have contraindications to using a COC or a contraceptive implant (Category 3 or 4 in the CDC Medical Eligibility Criteria [MEC])
• Because the CDC MEC are continuously revised, the most updated criteria will be used (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5904a3.htm)
• Women who are currently participating in a clinical trial or have participated within the past 30 days.
• Less than 2 weeks from the end of a pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COC users or new starts; 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.	Drug: Etonogestrel contraceptive implant; Place etonogestrel contraceptive implant.; Other Names: Nexplanon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Evaluating ENG Implant as Acceptable	Evaluate the acceptability (continuation of the implant throughout the study) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Evaluating ENG as Tolerable: Tolerability	Evaluate the tolerability (side effects) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception	52 weeks
Number of Participants Continuing COC	Continuation of COC over 52 weeks of evaluation regardless of whether or not the implant was still present at 52 weeks	52 weeks
Bleeding Patterns	Bleeding patterns while using a COC concomitantly with ENG implant	52 weeks
Post-study Method Plan	Plan to continue the COC and/or implant after the study based on interview at last visit	52 weeks

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: University of Colorado, Denver; University of Pennsylvania; Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Melissa C Matulich, MD MAS, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2020
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Contraceptive implant; Nexplanon; Combined oral contraceptive
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents; Etonogestrel
• Other Study ID Numbers: 1571368

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No