Premature Discontinuation of Contraceptive Implants

Phase 4

Recruiting

• Conditions: Contraception Behavior
• Interventions: Drug: Ethinyl Estradiol / Norgestimate Oral Tablet

• Registration Number: NCT04828824
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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).

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 Timeline

• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-02
• Study Start: 2021-06-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COCR Arm	Ethinyl Estradiol / Norgestimate Oral Tablet	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.

Primary Outcome Measures

Name	Time	Method
Implant Continuation	12 months post-insertion	We will assess continuation of use of the contraceptive implant.

Secondary Outcome Measures

Name	Time	Method
Satisfaction with contraceptive implant	3, 6, and 12 months post-insertion	We will assess satisfaction with bleeding profile and overall satisfaction using a Likert scale ("very satisfied", "somewhat satisfied" and "not satisfied").

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States