Trial Outcomes & Findings for Management of Etonogestrel Subdermal Implant-related Bleeding (NCT NCT01658995)
NCT ID: NCT01658995
Last Updated: 2021-01-26
Results Overview
The proportion of subjects who requested additional secondary treatment of intervention after ESI
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
82 participants
Primary outcome timeframe
After initial treatment up to 39 weeks
Results posted on
2021-01-26
Participant Flow
Participant milestones
| Measure |
Post ESI Implant - Doxycycline
Subjects who were randomization into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received Doxycycline 100 mg oral capsules, twice daily for 10 days. After 10 days subsequent treatment can requested by the subjects
|
Post ESI Implant - Placebo
Subjects who were randomization into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received placebo 100 mg oral capsules, twice daily for 10 days. After 10 days subsequent treatment can requested by the subjects
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
40
|
|
Overall Study
COMPLETED
|
42
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Management of Etonogestrel Subdermal Implant-related Bleeding
Baseline characteristics by cohort
| Measure |
Post ESI Implant - Doxycycline
n=42 Participants
Subjects who were randomization into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received Doxycycline 100 mg oral capsules, twice daily for 10 days. After 10 days subsequent treatment can requested by the subjects
|
Post ESI Implant - Placebo
n=40 Participants
Subjects who were randomization into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received placebo 100 mg oral capsules, twice daily for 10 days. After 10 days subsequent treatment can requested by the subjects
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.6 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
26.0 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
25.8 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
40 participants
n=7 Participants
|
82 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After initial treatment up to 39 weeksThe proportion of subjects who requested additional secondary treatment of intervention after ESI
Outcome measures
| Measure |
Post ESI Implant - Doxycycline
n=42 Participants
Subjects who were randomization into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received Doxycycline 100 mg oral capsules, twice daily for 10 days. After 10 days subsequent treatment can requested by the subjects
|
Post ESI Implant - Placebo
n=40 Participants
Subjects who were randomization into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received placebo 100 mg oral capsules, twice daily for 10 days. After 10 days subsequent treatment can requested by the subjects
|
|---|---|---|
|
Secondary Treatment
|
20 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 13 weeks post-treatmentPopulation: In Doxycycline arm 8 subjects were lost to follow up and did not complete any surveys after randomized to treatment. In Placebo arm 7 subjects were lost to follow up and did not complete any surveys after randomized to treatment.
Number of subjects who reported satisfaction with bleeding after 13 weeks post ESI insertion. As measured by the number of subjects answering very satisfied or satisfied on the Patient Satisfaction Survey question "To what extent have you been satisfied overall while using the contraceptive implant? Very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied or very dissatisfied."
Outcome measures
| Measure |
Post ESI Implant - Doxycycline
n=34 Participants
Subjects who were randomization into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received Doxycycline 100 mg oral capsules, twice daily for 10 days. After 10 days subsequent treatment can requested by the subjects
|
Post ESI Implant - Placebo
n=33 Participants
Subjects who were randomization into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received placebo 100 mg oral capsules, twice daily for 10 days. After 10 days subsequent treatment can requested by the subjects
|
|---|---|---|
|
Subject Satisfaction
|
15 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 26 weeks post-randomizationNumber of subjects who requested ESI removal
Outcome measures
| Measure |
Post ESI Implant - Doxycycline
n=42 Participants
Subjects who were randomization into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received Doxycycline 100 mg oral capsules, twice daily for 10 days. After 10 days subsequent treatment can requested by the subjects
|
Post ESI Implant - Placebo
n=40 Participants
Subjects who were randomization into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received placebo 100 mg oral capsules, twice daily for 10 days. After 10 days subsequent treatment can requested by the subjects
|
|---|---|---|
|
Removal of ESI
|
4 Participants
|
2 Participants
|
Adverse Events
Post ESI Implant - Doxycycline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post ESI Implant - Placebo
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