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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04423055
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : February 25, 2022
Sponsor:
Collaborators:
Merck Sharp & Dohme LLC
University of Colorado, Denver
University of Pennsylvania
Information provided by (Responsible Party):
University of California, Davis

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Etonogestrel contraceptive implant Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive: a Multicenter Trial
Actual Study Start Date : August 13, 2020
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arms and Interventions
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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 Name: Nexplanon


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Evaluating ENG Implant as Acceptable [ Time Frame: 52 weeks ]
    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


Secondary Outcome Measures :
  1. Number of Participants Evaluating ENG as Tolerable: Tolerability [ Time Frame: 52 weeks ]
    Evaluate the tolerability (side effects) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception

  2. Number of Participants Continuing COC [ Time Frame: 52 weeks ]
    Continuation of COC over 52 weeks of evaluation regardless of whether or not the implant was still present at 52 weeks

  3. Bleeding Patterns [ Time Frame: 52 weeks ]
    Bleeding patterns while using a COC concomitantly with ENG implant

  4. Post-study Method Plan [ Time Frame: 52 weeks ]
    Plan to continue the COC and/or implant after the study based on interview at last visit


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04423055


Contacts
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Contact: Melissa C Matulich, MD MAS 916-734-6670 mcmatulich@ucdavis.edu
Contact: Courtney B Overstreet, BS 916-734-6846 cboverstreet@ucdavis.edu

Locations
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United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Melissa C Matulich, MD MAS    916-734-6670    mcmatulich@ucdavis.edu   
Contact: Courtney B Overstreet, BS    916-734-6846    hs-obgynresearch@ucdavis.edu   
Principal Investigator: Melissa C Matulich, MD MAS         
United States, Colorado
University of Colorado Recruiting
Denver, Colorado, United States, 80045
Contact: Rebecca H Cohen, MD MPH    303-724-2015    rebecca.h.cohen@cuanschutz.edu   
Contact: Eva Dindinger, MPH    303-724-8482    eva.dindinger@cuanschutz.edu   
Principal Investigator: Rebecca H Cohen, MD MPH         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Andrea Roe, MD MPH    267-254-0225    andrea.roe@pennmedicine.upenn.edu   
Contact: Arden McAllister, MPH    215-662-3532    arden.mcallister@pennmedicine.upenn.edu   
Sponsors and Collaborators
University of California, Davis
Merck Sharp & Dohme LLC
University of Colorado, Denver
University of Pennsylvania
Investigators
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Principal Investigator: Melissa C Matulich, MD MAS University of California, Davis
More Information
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Additional Information:

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04423055    
Other Study ID Numbers: 1571368
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: February 25, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of California, Davis:
Contraceptive implant
Nexplanon
Combined oral contraceptive
Additional relevant MeSH terms:
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Contraceptive Agents
Etonogestrel
Reproductive Control Agents
 Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Contraceptive Agents, Female