Trial Outcomes & Findings for Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women (NCT NCT01534520)

NCT ID: NCT01534520

Last Updated: 2016-12-22

Results Overview

To assess change in pain from baseline to IUD insertion measured on a visual analog scale (VAS) from 0 mm (no pain) to 100 mm (worst pain in patient's life). This pain assessment was prior to (baseline) and at the time of IUD insertion following vaginal self-administration of study gel (either 2% lidocaine gel or placebo gel).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 61 participants
• Primary outcome timeframe: change in pain score from baseline (before IUD insertion) to time of IUD insertion
• Results posted on: 2016-12-22

Participant Flow

In total, 79 women presenting for IUD insertion at OPC, UPP, and GMO were approached for participation.

• 2 patients were removed from the study. Patients were considered screen failures before randomization to an arm. * 18 declined participation; 10 (56%) reported "time concerns" as their primary reason for declining.

Participant milestones

Measure	Group 1: Intravaginal 2% Lidocaine Gel 4 ml of 2% lidocaine gel for self vaginal insertion	Group 2: Intravaginal Placebo Gel Intravaginal insertion of 4ml of placebo gel (K-Y Jelly)
Overall Study STARTED	30	29
Overall Study COMPLETED	30	28
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Group 1: Intravaginal 2% Lidocaine Gel 4 ml of 2% lidocaine gel for self vaginal insertion	Group 2: Intravaginal Placebo Gel Intravaginal insertion of 4ml of placebo gel (K-Y Jelly)
Overall Study Adverse Event	0	1

Baseline Characteristics

Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women

Baseline characteristics by cohort

Measure	Group 1: Intravaginal 2% Lidocaine Gel n=30 Participants 4mL of 2% lidocaine gel for vaginal self-administration )	Group 2: Intravaginal Placebo Gel n=29 Participants 4mL placebo gel (K-Y Jelly) for vaginal self-administration	Total n=59 Participants Total of all reporting groups
Age, Customized Between 14-50	30 participants n=5 Participants	29 participants n=7 Participants	59 participants n=5 Participants
Gender Female	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: change in pain score from baseline (before IUD insertion) to time of IUD insertion

To assess change in pain from baseline to IUD insertion measured on a visual analog scale (VAS) from 0 mm (no pain) to 100 mm (worst pain in patient's life). This pain assessment was prior to (baseline) and at the time of IUD insertion following vaginal self-administration of study gel (either 2% lidocaine gel or placebo gel).

Outcome measures

Measure	Group 1: Intravaginal 2% Lidocaine Gel n=30 Participants Intravaginal insertion of 4mL of 2% lidocaine gel Placebo: KY Jelly	Group 2: Intravaginal Placebo Gel n=29 Participants Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly) Lidocaine: Intravaginal insertion of 5mL 2% lidocaine gel
Change in Pain From Baseline to IUD Insertion	61 change in visual analog scale score Interval 53.0 to 71.0	68 change in visual analog scale score Interval 58.0 to 80.0

SECONDARY outcome

Timeframe: After inserting the gel but prior to IUD insertion

Number of participants who rated self-application of study gel as "some what easy" or "very easy" on Likert scale

Outcome measures

Measure	Group 1: Intravaginal 2% Lidocaine Gel n=30 Participants Intravaginal insertion of 4mL of 2% lidocaine gel Placebo: KY Jelly	Group 2: Intravaginal Placebo Gel n=29 Participants Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly) Lidocaine: Intravaginal insertion of 5mL 2% lidocaine gel
To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD	29 participants who found gel easy to use	29 participants who found gel easy to use

SECONDARY outcome

Timeframe: Directly after IUD insertion

Population: Participants in each group self-administered the study gel as per instruction followed by insertion of the IUD by the physician 5 to 15 minutes later.

The physician who conducted the study visit and IUD insertion was asked about the difficulty/ease in placing the IUD immediately following the procedure and the percentage of IUD insertions considered to be "easy" was calculated for each study group.

Outcome measures

Measure	Group 1: Intravaginal 2% Lidocaine Gel n=30 Participants Intravaginal insertion of 4mL of 2% lidocaine gel Placebo: KY Jelly	Group 2: Intravaginal Placebo Gel n=29 Participants Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly) Lidocaine: Intravaginal insertion of 5mL 2% lidocaine gel
Percentage of IUDs Considered by Physicians Easy to Insert	87 percentage of insertions declared easy Interval 69.0 to 96.0	64 percentage of insertions declared easy Interval 44.0 to 81.0

SECONDARY outcome

Timeframe: 7 days post-insertion

Number of women taking pain medication for at least one day following IUD insertion

Outcome measures

Measure	Group 1: Intravaginal 2% Lidocaine Gel n=30 Participants Intravaginal insertion of 4mL of 2% lidocaine gel Placebo: KY Jelly	Group 2: Intravaginal Placebo Gel n=28 Participants Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly) Lidocaine: Intravaginal insertion of 5mL 2% lidocaine gel
Need for Pain Medication up to 7 Days	24 participants	27 participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Study Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=29 participants at risk Intravaginal insertion of 4mL placebo gel Placebo: KY Jelly	Study Drug n=30 participants at risk Intravaginal insertion of 4mL 2% lidocaine gel Lidocaine: Intravaginal insertion of 4mL 2% lidocaine gel
Reproductive system and breast disorders Intolerable Pain	3.4% 1/29 • Number of events 1	0.00% 0/30

Additional Information

Dionne Best

UPittsburgh

Phone: 412-641-5496

Email: dbest@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place