NCT04828824

Premature Discontinuation of Contraceptive Implants

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 14 Years – 23 Years
• Healthy volunteers: Accepted

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.

Conditions

• Contraception Behavior

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-18
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-04-02
• Last updated: 2024-05-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study