Premature Discontinuation of Contraceptive Implants

University of Colorado Denver (CU Denver)

Status and phase: Enrolling; Phase 4

Conditions: Contraception Behavior

Treatments: Drug: Ethinyl Estradiol / Norgestimate Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04828824

19-2750

Details and patient eligibility

About

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).

Full 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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 14 to 23 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

COCR Arm

Experimental group

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.

Treatment:

Drug: Ethinyl Estradiol / Norgestimate Oral Tablet

SOC Arm

No Intervention group

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.