Premature Discontinuation of Contraceptive Implants
Primary Purpose
Contraception Behavior
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ethinyl Estradiol / Norgestimate Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Contraception Behavior
Eligibility Criteria
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.
Sites / Locations
- Children's Hospital ColoradoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
COCR Arm
SOC Arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Implant Continuation
We will assess continuation of use of the contraceptive implant.
Secondary Outcome Measures
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").
Full Information
NCT ID
NCT04828824
First Posted
March 30, 2021
Last Updated
March 3, 2023
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT04828824
Brief Title
Premature Discontinuation of Contraceptive Implants
Official Title
Reduction of Premature Discontinuation of Contraceptive Implants by Advance Provision of an OCP-based Participant Intervention: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraception Behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
COCR Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
SOC Arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ethinyl Estradiol / Norgestimate Oral Tablet
Intervention Description
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 Outcome Measure Information:
Title
Implant Continuation
Description
We will assess continuation of use of the contraceptive implant.
Time Frame
12 months post-insertion
Secondary Outcome Measure Information:
Title
Satisfaction with contraceptive implant
Description
We will assess satisfaction with bleeding profile and overall satisfaction using a Likert scale ("very satisfied", "somewhat satisfied" and "not satisfied").
Time Frame
3, 6, and 12 months post-insertion
Other Pre-specified Outcome Measures:
Title
Implant-related health care interactions
Description
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.
Time Frame
within 12 months of insertion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanelle Sheeder, PhD
Phone
(303) 724-2272
Email
jeanelle.sheeder@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Graves
Phone
303-724-3514
Email
EMILY.GRAVES@CUANSCHUTZ.EDU
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Graves
Phone
303-724-3514
Email
EMILY.GRAVES@CUANSCHUTZ.EDU
First Name & Middle Initial & Last Name & Degree
Morgan Pena
Email
MORGAN.PENA@CUANSCHUTZ.EDU
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Premature Discontinuation of Contraceptive Implants
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