Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive

NCT04423055 | Completed Phase 4 FDA Drug

• 1 other identifier: 1571368
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Contraception

Keywords

Contraceptive implant; Nexplanon; Combined oral contraceptive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants Evaluating ENG as Tolerable: Tolerability

  52 weeks

• Number of Participants Continuing COC

  52 weeks

• Bleeding Patterns

  52 weeks

• Post-study Method Plan

  52 weeks

Study Arms (1)

COC users or new starts

EXPERIMENTAL

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

Interventions

Etonogestrel contraceptive implant DRUG

Place etonogestrel contraceptive implant.

Also known as: Nexplanon

COC users or new starts

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead
• Merck Sharp & Dohme LLC: collaborator
• University of Colorado, Denver: collaborator
• University of Pennsylvania: collaborator

Study Sites (3)

University of California, Davis

Sacramento, California, 95817, United States

Location

University of Colorado

Denver, Colorado, 80045, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

etonogestrel

Study Officials

• Melissa C Matulich, MD MAS

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: August 13, 2020
• Primary Completion: April 9, 2024
• Study Completion: April 9, 2024
• Last Updated: May 22, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)