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Report for Clinical Trial NCT01534520

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women: a Randomized Controlled Trial

This study is designed to evaluate if self-inserted intravaginal 2% lidocaine gel is effective at decreasing pain during intrauterine device insertion in nulliparous women.

NCT01534520 Pain

2 Interventions

Name: Lidocaine

Description: Intravaginal insertion of 4mL 2% lidocaine gel
Type: Drug
Group Labels: 1

Group 1: Intravaginal 2% lidocaine gel

Name: Placebo

Description: KY Jelly
Type: Drug
Group Labels: 1

Group 2: Intravaginal placebo gel


Primary Outcomes

Description: 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).

Measure: Change in Pain From Baseline to IUD Insertion

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

Secondary Outcomes

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

Measure: To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD

Time: After inserting the gel but prior to IUD insertion

Description: 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.

Measure: Percentage of IUDs Considered by Physicians Easy to Insert

Time: Directly after IUD insertion

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

Measure: Need for Pain Medication up to 7 Days

Time: 7 days post-insertion

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 T380A

Inclusion criteria: - Nulliparous, as defined in this study as no history of pregnancy ≥ 24 weeks gestational age - Desires insertion of either levonorgestrel-releasing IUD (LNG-IUD) or copper T380A IUD (Cu-IUD) - No history of pregnancy in the last 6 weeks - Able to provide written informed consent in English and comply with all study procedures Exclusion criteria: - Known allergy or hypersensitivity to lidocaine or other amino amide local anesthetics - Prior failed IUD insertion - Prior IUD use - Use of narcotic or benzodiazepine medication within the last 24 hours - U.S. Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for use of an IUD - Positive pregnancy test or reasonable risk of pregnancy due to unprotected heterosexual intercourse since the last menstrual period Inclusion criteria: - Nulliparous, as defined in this study as no history of pregnancy ≥ 24 weeks gestational age - Desires insertion of either levonorgestrel-releasing IUD (LNG-IUD) or copper T380A IUD (Cu-IUD) - No history of pregnancy in the last 6 weeks - Able to provide written informed consent in English and comply with all study procedures Exclusion criteria: - Known allergy or hypersensitivity to lidocaine or other amino amide local anesthetics - Prior failed IUD insertion - Prior IUD use - Use of narcotic or benzodiazepine medication within the last 24 hours - U.S. Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for use of an IUD - Positive pregnancy test or reasonable risk of pregnancy due to unprotected heterosexual intercourse since the last menstrual period Pain Intrauterine devices (IUDs) are among the most effective forms of reversible contraception. --- T380A ---

Inclusion criteria: - Nulliparous, as defined in this study as no history of pregnancy ≥ 24 weeks gestational age - Desires insertion of either levonorgestrel-releasing IUD (LNG-IUD) or copper T380A IUD (Cu-IUD) - No history of pregnancy in the last 6 weeks - Able to provide written informed consent in English and comply with all study procedures Exclusion criteria: - Known allergy or hypersensitivity to lidocaine or other amino amide local anesthetics - Prior failed IUD insertion - Prior IUD use - Use of narcotic or benzodiazepine medication within the last 24 hours - U.S. Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for use of an IUD - Positive pregnancy test or reasonable risk of pregnancy due to unprotected heterosexual intercourse since the last menstrual period Inclusion criteria: - Nulliparous, as defined in this study as no history of pregnancy ≥ 24 weeks gestational age - Desires insertion of either levonorgestrel-releasing IUD (LNG-IUD) or copper T380A IUD (Cu-IUD) - No history of pregnancy in the last 6 weeks - Able to provide written informed consent in English and comply with all study procedures Exclusion criteria: - Known allergy or hypersensitivity to lidocaine or other amino amide local anesthetics - Prior failed IUD insertion - Prior IUD use - Use of narcotic or benzodiazepine medication within the last 24 hours - U.S. Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for use of an IUD - Positive pregnancy test or reasonable risk of pregnancy due to unprotected heterosexual intercourse since the last menstrual period Pain Intrauterine devices (IUDs) are among the most effective forms of reversible contraception. --- T380A --- --- T380A ---



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