Trial Outcomes & Findings for Premature Discontinuation of Contraceptive Implants (NCT NCT04828824)
NCT ID: NCT04828824
Last Updated: 2026-04-23
Results Overview
We will assess continuation of use of the contraceptive implant.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
600 participants
Primary outcome timeframe
12 months post-insertion
Results posted on
2026-04-23
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
300
|
300
|
|
Overall Study
COMPLETED
|
282
|
283
|
|
Overall Study
NOT COMPLETED
|
18
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Premature Discontinuation of Contraceptive Implants
Baseline characteristics by cohort
| Measure |
COCR Arm
n=300 Participants
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.
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.
|
SOC Arm
n=300 Participants
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.
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
111 Participants
n=60 Participants
|
116 Participants
n=56 Participants
|
227 Participants
n=116 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
189 Participants
n=60 Participants
|
184 Participants
n=56 Participants
|
373 Participants
n=116 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Age, Continuous
|
18.7 Years
n=60 Participants
|
18.6 Years
n=56 Participants
|
18.6 Years
n=116 Participants
|
|
Sex: Female, Male
Female
|
300 Participants
n=60 Participants
|
300 Participants
n=56 Participants
|
600 Participants
n=116 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
156 Participants
n=60 Participants
|
170 Participants
n=56 Participants
|
326 Participants
n=116 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
122 Participants
n=60 Participants
|
103 Participants
n=56 Participants
|
225 Participants
n=116 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=60 Participants
|
27 Participants
n=56 Participants
|
49 Participants
n=116 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
11 Participants
n=60 Participants
|
5 Participants
n=56 Participants
|
16 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=60 Participants
|
19 Participants
n=56 Participants
|
29 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=60 Participants
|
6 Participants
n=56 Participants
|
8 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 Participants
n=60 Participants
|
28 Participants
n=56 Participants
|
71 Participants
n=116 Participants
|
|
Race (NIH/OMB)
White
|
152 Participants
n=60 Participants
|
135 Participants
n=56 Participants
|
287 Participants
n=116 Participants
|
|
Race (NIH/OMB)
More than one race
|
29 Participants
n=60 Participants
|
40 Participants
n=56 Participants
|
69 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
53 Participants
n=60 Participants
|
67 Participants
n=56 Participants
|
120 Participants
n=116 Participants
|
|
Region of Enrollment
United States
|
300 participants
n=60 Participants
|
300 participants
n=56 Participants
|
600 participants
n=116 Participants
|
PRIMARY outcome
Timeframe: 12 months post-insertionWe will assess continuation of use of the contraceptive implant.
Outcome measures
| Measure |
COCR Arm
n=282 Participants
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.
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.
|
SOC Arm
n=283 Participants
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.
|
|---|---|---|
|
Number of Participants With Implant Continuation
|
219 Participants
|
225 Participants
|
SECONDARY outcome
Timeframe: Assessed at 3, 6, and 12 months post-insertion, 12 months reportedWe 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.
Outcome measures
| Measure |
COCR Arm
n=200 Participants
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.
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.
|
SOC Arm
n=212 Participants
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.
|
|---|---|---|
|
Overall Satisfaction With Contraceptive Implant
Somewhat satisfied
|
64 Participants
|
73 Participants
|
|
Overall Satisfaction With Contraceptive Implant
Very dissatisfied
|
11 Participants
|
9 Participants
|
|
Overall Satisfaction With Contraceptive Implant
Somewhat dissatisfied
|
16 Participants
|
16 Participants
|
|
Overall Satisfaction With Contraceptive Implant
Not satisfied or dissatisfied
|
24 Participants
|
20 Participants
|
|
Overall Satisfaction With Contraceptive Implant
Very satisfied
|
85 Participants
|
94 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: within 12 months of insertionWe 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.
Outcome measures
| Measure |
COCR Arm
n=282 Participants
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.
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.
|
SOC Arm
n=283 Participants
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.
|
|---|---|---|
|
Implant-related Health Care Interactions
|
0 Interactions
Interval 0.0 to 3.0
|
0 Interactions
Interval 0.0 to 3.0
|
Adverse Events
COCR Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SOC Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place