Premature Discontinuation of Contraceptive Implants

NCT04828824 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 19-2750
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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).

Conditions

Contraception Behavior

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Implant Continuation

  We will assess continuation of use of the contraceptive implant.

  12 months post-insertion

Secondary Outcomes (1)

• Overall Satisfaction With Contraceptive Implant

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

Other Outcomes (1)

• Implant-related Health Care Interactions

  within 12 months of insertion

Study Arms (2)

COCR Arm

EXPERIMENTAL

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

SOC Arm

NO INTERVENTION

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.

Interventions

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.

COCR Arm

Eligibility Criteria

• Age: 14 Years - 23 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Contraception Behavior

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr Jeanelle Sheeder
• Organization: University of Colorado

JEANELLE.SHEEDER@CUANSCHUTZ.EDU

(303)724-2272

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 2, 2021
• Study Start: June 18, 2021
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: April 23, 2026
• Results First Posted: April 23, 2026

Record last verified: 2026-04

Locations

US (1)