Contraception Behavior
Conditions
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: 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.
Interventions
DRUGEthinyl 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.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 23 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Implant Continuation | 12 months post-insertion | We will assess continuation of use of the contraceptive implant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Satisfaction With Contraceptive Implant | Assessed at 3, 6, and 12 months post-insertion, 12 months reported | We will assess satisfaction with the bleeding profile and overall satisfaction using a Likert scale ("very satisfied", "somewhat satisfied" and "not satisfied"). Overall satisfaction at 12 months will be used as a measure for data analysis. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 227 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 373 Participants |
| Age, Continuous | 18.7 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 156 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 49 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 16 Participants |
| Race (NIH/OMB) Asian | 19 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants |
| Race (NIH/OMB) More than one race | 69 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 8 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 67 Participants |
| Race (NIH/OMB) White | 287 Participants |
| Region of Enrollment United States | 300 participants |
| Sex: Female, Male Female | 600 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 300 | 0 / 300 |
| other Total, other adverse events | 0 / 300 | 0 / 300 |
| serious Total, serious adverse events | 0 / 300 | 0 / 300 |
Outcome results
None listed