Trial Outcomes & Findings for Nexplanon and Combined Oral Contraceptive (COC) Combined Use Study (NCT NCT02852265)
NCT ID: NCT02852265
Last Updated: 2018-12-28
Results Overview
Evaluate the acceptability (continuation of the implant throughout the study) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
6 months
Results posted on
2018-12-28
Participant Flow
We consented and enrolled 20 women in the outpatient clinic at the University of California, Davis Department of Obstetrics and Gynecology for study participation between September and December 2016.
Participant milestones
| Measure |
New Start COC Users
Women who are starting or recently started (within last 4 weeks) a combined oral contraceptive
|
Continuing COC Users
Women who have been using a combined oral contraceptive for more than 4 weeks
|
|---|---|---|
|
1-month Follow-up
STARTED
|
10
|
10
|
|
1-month Follow-up
COMPLETED
|
10
|
10
|
|
1-month Follow-up
NOT COMPLETED
|
0
|
0
|
|
3-month Follow-up
STARTED
|
10
|
10
|
|
3-month Follow-up
COMPLETED
|
9
|
9
|
|
3-month Follow-up
NOT COMPLETED
|
1
|
1
|
|
6-month Follow-up
STARTED
|
9
|
9
|
|
6-month Follow-up
COMPLETED
|
9
|
9
|
|
6-month Follow-up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
New Start COC Users
Women who are starting or recently started (within last 4 weeks) a combined oral contraceptive
|
Continuing COC Users
Women who have been using a combined oral contraceptive for more than 4 weeks
|
|---|---|---|
|
3-month Follow-up
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Nexplanon and Combined Oral Contraceptive (COC) Combined Use Study
Baseline characteristics by cohort
| Measure |
New Start COC Starters
n=10 Participants
Women who are starting or recently started (within last 4 weeks) a combined oral contraceptive
|
Continuing COC Users
n=10 Participants
Women who have been using a combined oral contraceptive for more than 4 weeks
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25 years
n=5 Participants
|
20.5 years
n=7 Participants
|
23 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Pill type
21/7 monophasic
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Pill type
24/4 monophasic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Pill type
21/7 triphasic
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Pill type
Continuous dosing
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All women enrolled in study
Evaluate the acceptability (continuation of the implant throughout the study) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception
Outcome measures
| Measure |
New Start COC Users
n=10 Participants
Women who are starting or recently started (within last 4 weeks) a combined oral contraceptive
|
Continuing COC Users
n=10 Participants
Women who have been using a combined oral contraceptive for more than 4 weeks
|
|---|---|---|
|
Number of Participants Evaluating ENG as Acceptable: Acceptability (Measurement: Questionnaire)
|
9 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All enrolled subjects, new or worsening side effects after 6 months of use in women using both an implant and a COC
Evaluate the tolerability (side effects) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception
Outcome measures
| Measure |
New Start COC Users
n=5 Participants
Women who are starting or recently started (within last 4 weeks) a combined oral contraceptive
|
Continuing COC Users
n=5 Participants
Women who have been using a combined oral contraceptive for more than 4 weeks
|
|---|---|---|
|
Number of Participants Evaluating ENG as Tolerable: Tolerability (Measurement: Diaries and Questionnaire)
headache
|
2 participants
|
0 participants
|
|
Number of Participants Evaluating ENG as Tolerable: Tolerability (Measurement: Diaries and Questionnaire)
nausea
|
1 participants
|
0 participants
|
|
Number of Participants Evaluating ENG as Tolerable: Tolerability (Measurement: Diaries and Questionnaire)
mastalgia
|
1 participants
|
0 participants
|
|
Number of Participants Evaluating ENG as Tolerable: Tolerability (Measurement: Diaries and Questionnaire)
mood complaints
|
1 participants
|
0 participants
|
|
Number of Participants Evaluating ENG as Tolerable: Tolerability (Measurement: Diaries and Questionnaire)
worsening acne
|
2 participants
|
0 participants
|
|
Number of Participants Evaluating ENG as Tolerable: Tolerability (Measurement: Diaries and Questionnaire)
worsening dysmenorrhea
|
2 participants
|
1 participants
|
|
Number of Participants Evaluating ENG as Tolerable: Tolerability (Measurement: Diaries and Questionnaire)
weight gain
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: women using or starting a COC and having an etonogestrel implant placed; 1 lost to follow-up in each group from enrollment (n=10 in both groups at enrollment)
Demonstrate that women desiring a COC are willing to use ENG implant concomitantly as a continuous "back-up" contraceptive
Outcome measures
| Measure |
New Start COC Users
n=10 Participants
Women who are starting or recently started (within last 4 weeks) a combined oral contraceptive
|
Continuing COC Users
n=10 Participants
Women who have been using a combined oral contraceptive for more than 4 weeks
|
|---|---|---|
|
Patient Interest (Measurement: Ability to Enroll)
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: women using or starting a COC and having an etonogestrel implant placed; 1 lost to follow-up in each group from enrollment (n=10 in both groups at enrollment)
Bleeding patterns while using a COC concomitantly with ENG implant
Outcome measures
| Measure |
New Start COC Users
n=9 Participants
Women who are starting or recently started (within last 4 weeks) a combined oral contraceptive
|
Continuing COC Users
n=9 Participants
Women who have been using a combined oral contraceptive for more than 4 weeks
|
|---|---|---|
|
Bleeding Patterns (Measurement: Diaries)
prolonged 1st 90 days
|
1 Participants
|
1 Participants
|
|
Bleeding Patterns (Measurement: Diaries)
frequent 1st 90 days
|
2 Participants
|
1 Participants
|
|
Bleeding Patterns (Measurement: Diaries)
irregular 1st 90 days
|
2 Participants
|
2 Participants
|
|
Bleeding Patterns (Measurement: Diaries)
infrequent 1st 90 days
|
1 Participants
|
3 Participants
|
|
Bleeding Patterns (Measurement: Diaries)
amenorrhea 1st 90 days
|
0 Participants
|
0 Participants
|
|
Bleeding Patterns (Measurement: Diaries)
regular 1st 90 days
|
3 Participants
|
2 Participants
|
|
Bleeding Patterns (Measurement: Diaries)
prolonged 2nd 90 days
|
0 Participants
|
1 Participants
|
|
Bleeding Patterns (Measurement: Diaries)
frequent 2nd 90 days
|
0 Participants
|
2 Participants
|
|
Bleeding Patterns (Measurement: Diaries)
irregular 2nd 90 days
|
2 Participants
|
2 Participants
|
|
Bleeding Patterns (Measurement: Diaries)
infrequent 2nd 90 days
|
5 Participants
|
2 Participants
|
|
Bleeding Patterns (Measurement: Diaries)
amenorrhea 2nd 90 days
|
1 Participants
|
1 Participants
|
|
Bleeding Patterns (Measurement: Diaries)
regular 2nd 90 days
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: women using or starting a COC and having an etonogestrel implant placed; 1 lost to follow-up in each group from enrollment (n=10 in both groups at enrollment)
Continuation rate of COC over 6 months of evaluation regardless on whether or not the implant was still present at 6 months
Outcome measures
| Measure |
New Start COC Users
n=9 Participants
Women who are starting or recently started (within last 4 weeks) a combined oral contraceptive
|
Continuing COC Users
n=9 Participants
Women who have been using a combined oral contraceptive for more than 4 weeks
|
|---|---|---|
|
COC Continuation Rate (Measurement: Participant Interview)
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: women using or starting a COC and having an etonogestrel implant placed; 1 lost to follow-up in each group from enrollment (n=10 in both groups at enrollment)
Plan to continue the COC and/or implant after the study based on interview at last visit
Outcome measures
| Measure |
New Start COC Users
n=9 Participants
Women who are starting or recently started (within last 4 weeks) a combined oral contraceptive
|
Continuing COC Users
n=9 Participants
Women who have been using a combined oral contraceptive for more than 4 weeks
|
|---|---|---|
|
Post-study Method Plan (Measurement: Participant Interview)
using implant only
|
3 Participants
|
4 Participants
|
|
Post-study Method Plan (Measurement: Participant Interview)
using COC only
|
1 Participants
|
3 Participants
|
|
Post-study Method Plan (Measurement: Participant Interview)
using implant and COC
|
5 Participants
|
2 Participants
|
|
Post-study Method Plan (Measurement: Participant Interview)
not using implant or COC
|
0 Participants
|
0 Participants
|
Adverse Events
New Start COC Users
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Continuing COC Users
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
New Start COC Users
n=10 participants at risk
Women who are starting or recently started (within last 4 weeks) a combined oral contraceptive
|
Continuing COC Users
n=10 participants at risk
Women who have been using a combined oral contraceptive for more than 4 weeks
|
|---|---|---|
|
Surgical and medical procedures
Nexplanon removal
|
10.0%
1/10 • Number of events 1 • 6 months of follow-up
|
10.0%
1/10 • Number of events 1 • 6 months of follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place