Premature Discontinuation of Contraceptive Implants

Contraception Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04828824
• Other study ID #: 19-2750
• Status: Recruiting
• Phase: Phase 4
• Start date: June 18, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Jeanelle Sheeder, PhD
• Phone: (303) 724-2272
• Email: jeanelle.sheeder[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 23 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception Behavior

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Implant Continuation	We will assess continuation of use of the contraceptive implant.	12 months post-insertion
Secondary	Satisfaction with contraceptive implant	We will assess satisfaction with bleeding profile and overall satisfaction using a Likert scale ("very satisfied", "somewhat satisfied" and "not satisfied").	3, 6, and 12 months post-insertion