Nexplanon and Combined Oral Contraceptive (COC) Combined Use Study (NexTOC)

Nexplanon Use in Women Primarily Choosing a Combined Hormonal Contraceptive: a Proof of Concept Trial

Women currently using or starting a combined oral contraceptive will be offered study enrollment. Study subjects will have a Nexplanon placed and followed for 6 months to evaluate if they continue the COC, continue the implant, or both, and to assess adverse events and bleeding patterns.

Study Overview

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

Detailed Description

The investigators will recruit women being seen in a UC Davis medical office or who contact our research office. Potential participants must be women currently COCs or intending to initiate COCs at the time of the office visit. The investigators expect that most women will be recruited while in the office who decide to initiate COCs or are continuing COC use-these women will be offered the ability to talk to research staff about the study.

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 receive a prescription for the desired COC (if needed) and 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 A follow-up visit will occur at 1 month (+1 week) and 3 and 6 months (+2 weeks). The diary will be reviewed and a copy made to keep with the source documentation. 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. At the 1 and 3 month visits, additional diaries will be dispensed as needed. The ENG implant will be removed upon request at any time during the study.

A phone call will occur approximately 1 week prior to the 3 and 6 month visits to check status and remind subject of the scheduled visit. Study participation will be complete after the 6 month follow-up visit.

No surveys will be used that the subject fills out herself. A daily diary will be used.

No blood draws will occur during this study.

Data to be collected by study staff include demographics, past medical and gynecologic history, prior and current contraceptive use, and reason for using COC (contraception, medical or both).

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. We would 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 (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion:

• Women being seen in a UC Davis medical office or who contact our research office.
• Potential participants must be women currently COCs or intending to initiate COCs at the time of the office visit.

Exclusion:

• Women who have contraindications to using a COC or a contraceptive implant (Category 3 or 4 in the CDC Medical Eligibility Criteria) will be excluded.
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

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 a etonogestrel contraceptive implant placed at enrollment. Women using COC as method of contraception for at least 1 month will be considered COC users. Women starting a COC or recently started a COC within the past month will be considered new starts.	Drug: Etonogestrel contraceptive implant; Place nexplanon; Other Names: Nexplanon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Evaluating ENG as Acceptable: Acceptability (Measurement: Questionnaire)	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	6 months
Number of Participants Evaluating ENG as Tolerable: Tolerability (Measurement: Diaries and Questionnaire)	Evaluate the tolerability (side effects) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Interest (Measurement: Ability to Enroll)	Demonstrate that women desiring a COC are willing to use ENG implant concomitantly as a continuous "back-up" contraceptive	6 months
Bleeding Patterns (Measurement: Diaries)	Bleeding patterns while using a COC concomitantly with ENG implant	6 months
COC Continuation Rate (Measurement: Participant Interview)	Continuation rate of COC over 6 months of evaluation regardless on whether or not the implant was still present at 6 months	6 months
Post-study Method Plan (Measurement: Participant Interview)	Plan to continue the COC and/or implant after the study based on interview at last visit	6 months

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Mitchell Creinin, MD, Univeristy of California, Davis

Publications and helpful links

General Publications

• Chen MJ, Hsia JK, Creinin MD. Etonogestrel implant use in women primarily choosing a combined oral contraceptive pill: A proof-of-concept trial. Contraception. 2018 Jun;97(6):533-537. doi: 10.1016/j.contraception.2018.02.009. Epub 2018 Feb 26.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2016
• Primary Completion (Actual): July 26, 2017
• Study Completion (Actual): July 26, 2017

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (Estimate): August 2, 2016

Study Record Updates

• Last Update Posted (Actual): December 28, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: adherence; contraception; contraceptive implant; oral contraceptive; adverse event
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents; Etonogestrel
• Other Study ID Numbers: 890433

Plan for Individual participant data (IPD)

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