Trial Outcomes & Findings for A Trial of 2% Lidocaine Gel for Intrauterine Device (IUD) Insertion (NCT NCT01292447)
NCT ID: NCT01292447
Last Updated: 2020-09-02
Results Overview
0 to 100 mm visual analog scale, higher values represent more pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
Day 1
Results posted on
2020-09-02
Participant Flow
Participant milestones
| Measure |
Control Group
Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement.
Placebo gel: Inert gel x 1
|
Study Group
Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement.
2% lidocaine gel: 120mg lidocaine x 1
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
73
|
72
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of 2% Lidocaine Gel for Intrauterine Device (IUD) Insertion
Baseline characteristics by cohort
| Measure |
Control Group
n=73 Participants
Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement.
Placebo gel: Inert gel x 1
|
Study Group
n=72 Participants
Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement.
2% lidocaine gel: 120mg lidocaine x 1
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.2 years
STANDARD_DEVIATION 5 • n=93 Participants
|
26.2 years
STANDARD_DEVIATION 5.3 • n=4 Participants
|
25.7 years
STANDARD_DEVIATION 5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=93 Participants
|
72 Participants
n=4 Participants
|
145 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 10 to 100 mm visual analog scale, higher values represent more pain.
Outcome measures
| Measure |
Control Group
n=73 Participants
Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement.
Placebo gel: Inert gel x 1
|
Study Group
n=72 Participants
Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement.
2% lidocaine gel: 120mg lidocaine x 1
|
|---|---|---|
|
Mean Pain Score During IUD Insertion
|
36.7 score on a scale
Standard Deviation 30
|
35.2 score on a scale
Standard Deviation 27.7
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Study Group
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 |
Control Group
n=73 participants at risk
Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement.
Placebo gel: Inert gel x 1
|
Study Group
n=72 participants at risk
Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement.
2% lidocaine gel: 120mg lidocaine x 1
|
|---|---|---|
|
Surgical and medical procedures
Acute complication
|
1.4%
1/73 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place