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OpenTrials
Completed

NCT Number: NCT04828824

Premature Discontinuation of Contraceptive Implants

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).

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Key information

Conditions

Contraception Behavior Behavior Reproductive Behavior

Age range

14 year–23 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ethinyl Estradiol / Norgestimate Oral Tablet

Drug

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.

Primary outcomes

  1. Number of Participants With Implant Continuation

    Time frame: 12 months post-insertion

    We will assess continuation of use of the contraceptive implant.

Secondary outcomes

  1. Overall Satisfaction With Contraceptive Implant

    Time frame: Assessed at 3, 6, and 12 months post-insertion, 12 months reported

    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.

Other outcomes

  1. Implant-related Health Care Interactions

    Time frame: within 12 months of insertion

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 2, 2021
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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