Premature Discontinuation of Contraceptive Implants

Reduction of Premature Discontinuation of Contraceptive Implants by Advance Provision of an OCP-based Participant Intervention: Randomized Clinical Trial

To compare rates of etonogestrel implant discontinuation in implant initiators who are given advance provision of combined oral contraceptive pills (COCs) and a bleeding rescue regimen (COCR intervention) to participants given standard counseling (comparator).

Study Overview

• Status: Completed
• Conditions: Contraception Behavior
• Intervention / Treatment: Drug: Ethinyl Estradiol / Norgestimate Oral Tablet

Detailed Description

Objective:

To compare rates of etonogestrel implant discontinuation in implant initiators who are given advance provision of combined oral contraceptive pills (COCs) and a bleeding rescue regimen (COCR intervention) to participants given standard counseling (comparator).

Secondary Objectives:

To determine if participants initiating the contraceptive implant who are also provided COCR are more likely than participants receiving standard counseling to:

1. report higher levels of satisfaction with their contraceptive implant at one year following initiation
2. require less clinical follow-up and clinical resources in the year following initiation.

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 23 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. You are between ages of 14 to 22.9 years.
2. Started etonogestrel implant for the first time and have never used the implant before.

Exclusion Criteria:

1. There is any contraindication to estrogen containing birth control.
2. Desire of pregnancy in next 12 months.
3. Plans to move from the area in next 12 months and is not able to come to the clinic.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COCR Arm; Participants in the COCR arm will receive three packs of combined oral contraceptive pills (35mcg ethinyl estradiol/norgestimate) and a specific protocol for their use for bothersome bleeding.	Drug: Ethinyl Estradiol / Norgestimate Oral Tablet; Those who desire COCs as an intervention are prescribed (over the phone) or given (in person) 3 packs of COCs. They are told to take one pill per day until the first pack is complete and save the remaining 2 packs for possible future use.
No Intervention: SOC Arm; Participants in the SC arm will be offered care according to our standardized protocol, which may include STI testing, reassurance and monitoring, prescription of COCs if desired, or removal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Implant Continuation	We will assess continuation of use of the contraceptive implant.	12 months post-insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Satisfaction With Contraceptive Implant	We will assess satisfaction with the bleeding profile and overall satisfaction using a Likert scale ("very satisfied", "somewhat satisfied" and "not satisfied"). Overall satisfaction at 12 months will be used as a measure for data analysis.	Assessed at 3, 6, and 12 months post-insertion, 12 months reported

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant-related Health Care Interactions	We will assess the number of healthcare interactions (phone calls, visits, messages, prescription refills) that are related to the use of the contraceptive implant or oral contraceptives dispensed in this study using the electronic medical record system.	within 12 months of insertion

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2021
• Primary Completion (Actual): November 12, 2025
• Study Completion (Actual): November 12, 2025

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Reproductive Behavior; Contraception Behavior; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Moxifloxacin
• Other Study ID Numbers: 19-2750

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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