Premature Discontinuation of Contraceptive Implants

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT04828824

Collaborator

(none)

600

Enrollment

Location

Arms

26.4

Anticipated Duration (Months)

22.7

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Contraception Behavior	Drug: Ethinyl Estradiol / Norgestimate Oral Tablet	Phase 4

Detailed Description

Objective:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 18, 2021

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: COCR Arm 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 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.
No Intervention: SOC Arm 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.

Arm

Intervention/Treatment

Experimental: COCR Arm

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

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.

No Intervention: SOC Arm

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.

Outcome Measures

Primary Outcome Measures

Implant Continuation [12 months post-insertion]
We will assess continuation of use of the contraceptive implant.

Secondary Outcome Measures

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").

Other Outcome Measures

Implant-related health care interactions [within 12 months of insertion]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 23 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital Colorado	Aurora	Colorado	United States	80045

Sponsors and Collaborators

University of Colorado, Denver

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT04828824

Other Study ID Numbers:

19-2750

First Posted:

Apr 2, 2021

Last Update Posted:

Aug 19, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Norgestimate, ethinyl estradiol drug combination

Estradiol

Study Results

No Results Posted as of Aug 19, 2021